[ { "nct": "NCT00000378", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Sertraline vs nortriptyline, both antidepressants; no placebo arm.", "decided_by": "both_coders" }, { "nct": "NCT00006170", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "weight-concerns smoking-cessation intervention", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "standard smoking-cessation counselling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "2x2 factorial (bupropion vs placebo x counselling type); one comparison per counselling background.", "decided_by": "both_coders" }, { "nct": "NCT00027378", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "treatment as usual (CBT/MET psychotherapy)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Adolescents with comorbid alcohol use disorder and depression; depression taken as the main target of the antidepressant.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00043550", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline", "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Drug arm switched week-8 sertraline non-responders to venlafaxine. Supportive-expressive psychotherapy arm (EG001) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00048815", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Minor depression.", "note": "St. John's Wort arm (EG001) excluded: herbal, not on the list and not described as an antidepressant. Placebo is double-dummy.", "decided_by": "both_coders" }, { "nct": "NCT00052078", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG003" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "CBT alone (EG001, no pill placebo) and sertraline+CBT (EG002, gets CBT the placebo group lacks) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00056472", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "olanzapine", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Psychotic depression.", "note": "Both arms got olanzapine; sertraline vs placebo added to it.", "decided_by": "both_coders" }, { "nct": "NCT00057551", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Chronic depression.", "note": "Open-label; every arm gets medication (switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine); trial tests CBASP and supportive psychotherapy added at entry. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00062738", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "nortriptyline", "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in Parkinson's disease.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00066937", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Temporomandibular disorder pain.", "note": "2x2: nortriptyline vs benztropine x CBT vs disease management. Benztropine is an active drug (likely an anticholinergic active placebo), not placebo. If accepted as placebo: EG000 vs EG001 (CBT) and EG002 vs EG003 (disease management).", "decided_by": "both_coders" }, { "nct": "NCT00070941", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in Parkinson's disease.", "note": "Double-dummy. SAM-e arm (EG000) excluded: supplement, not on the list and not described as an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT00074802", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Social anxiety disorder.", "note": "Phase 1 paroxetine for all; partial responders randomized to continued paroxetine with or without CBT. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00074815", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Pediatric OCD in SRI partial responders.", "note": "SRI medication management continues in every arm; trial tests CBT vs instructional CBT vs none. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00078286", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in chronic heart failure.", "note": "AE groups are described as serious adverse events by arm.", "decided_by": "both_coders" }, { "nct": "NCT00078754", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Intermittent explosive disorder.", "note": "Divalproex arm (EG001) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00078767", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "trauma-focused CBT", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD in sexually abused youth.", "note": "Placebo arm's intervention list also names sertraline, but its description is a matched placebo.", "decided_by": "both_coders" }, { "nct": "NCT00086138", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression of Alzheimer's disease (depression is the target, not behavioural symptoms).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00086190", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "paroxetine", "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in Parkinson's disease.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00086307", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "pramipexole", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Double-dummy, no placebo-only arm. Escitalopram+pramipexole (EG002) vs pramipexole+placebo (EG000) differ only in escitalopram. Escitalopram+placebo (EG001) has no matching placebo group, excluded.", "decided_by": "both_coders" }, { "nct": "NCT00086385", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Open-label; every arm gets 12 weeks of bupropion plus NRT, then randomized extended NRT/counselling conditions. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00086411", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "2x2 double-dummy: bupropion vs nicotine patch x counselling type. No placebo-only arm; bupropion's comparator is the nicotine patch.", "decided_by": "both_coders" }, { "nct": "NCT00101452", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Weeks 1-12 groups used. SAMe (EG000) excluded (described as a natural substance, not an antidepressant). Weeks 12-24 continuation groups EG003-EG005 (responders continuing, same people) and SAMe+escitalopram crossover EG006 excluded.", "decided_by": "both_coders" }, { "nct": "NCT00105586", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Late-life generalized anxiety disorder.", "note": "Placebo arm's intervention list names escitalopram; the group is described as placebo.", "decided_by": "both_coders" }, { "nct": "NCT00105989", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Prevention of MDD recurrence.", "note": "34 weeks of duloxetine for all, then randomized to continue it or switch to placebo. AE groups don't name their period; taken as the randomized phase since a placebo group is reported, with duloxetine split by dose.", "decided_by": "both_coders" }, { "nct": "NCT00107120", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00113295", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Refractory generalized anxiety disorder.", "note": "Open-label paroxetine CR (EG002, phase 1), then non-remitters randomized to quetiapine or placebo added to continued paroxetine. Tests quetiapine.", "decided_by": "both_coders" }, { "nct": "NCT00114127", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Social anxiety disorder.", "note": "Open-label duloxetine 60 mg, then non-remitters randomized to 60 mg + placebo or 120 mg: a dose comparison; no group off duloxetine.", "decided_by": "both_coders" }, { "nct": "NCT00116857", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in coronary heart disease.", "note": "Sertraline in both arms; tests omega-3 vs corn-oil placebo.", "decided_by": "both_coders" }, { "nct": "NCT00118404", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "acute-phase cognitive therapy before the continuation phase (all participants)", "combination": null } ], "design": "other", "indication": "depressive", "indication_note": "Recurrent depression; preventing relapse after acute-phase cognitive therapy.", "note": "Design other: everyone had 12 weeks of acute-phase cognitive therapy, and fluoxetine or pill placebo started only in the prophylactic continuation phase after it, so the drug wasn't randomized at the start and no one took it before (not a withdrawal). Continuation cognitive therapy (EG001) left out. EG000 and EG002 have titles and descriptions that conflict (the descriptions look swapped); coded by title, so check the direction.", "decided_by": "third_reader" }, { "nct": "NCT00118417", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Treatment-resistant panic disorder.", "note": "Open-label SSRI phase, then SSRI continued in all arms (placebo vs dose increase, then CBT vs clonazepam). AE groups also pool arms by phase.", "decided_by": "both_coders" }, { "nct": "NCT00118430", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with musculoskeletal pain; both targeted, depression taken as main.", "note": "Open-label stepped care (antidepressant, then pain self-management) vs usual care; no placebo. The no-treatment cohort has no AE group.", "decided_by": "both_coders" }, { "nct": "NCT00124306", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful bladder syndrome / interstitial cystitis.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00127673", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "PTSD.", "note": "Sertraline vs CBT with participants randomized to choice or no choice of treatment (preference design). No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00129272", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "CBT for smoking cessation", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in young people; official title mentions depressed youth.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00129467", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in hospice cancer patients.", "note": "An SSRI (continued, or citalopram) in both arms; tests methylphenidate vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00131456", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Comorbid depression and cannabis use disorder; depression taken as main.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00136318", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "peginterferon alfa-2a plus ribavirin", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention of interferon-associated depression in hepatitis C.", "note": "Escitalopram or placebo started 2 weeks before antiviral therapy.", "decided_by": "both_coders" }, { "nct": "NCT00136760", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "contingent reinforcement (contingency management)", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "non-contingent reinforcement", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking in people with schizophrenia; both other psychiatric.", "note": "2x2 factorial; one comparison per reinforcement condition.", "decided_by": "both_coders" }, { "nct": "NCT00149643", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Comorbid MDD and cannabis use disorder; depression taken as main.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00149799", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "other_psychiatric", "indication_note": "Body dysmorphic disorder.", "note": "Open-label phase I (EG000) excluded; responders randomized to continue escitalopram or switch to placebo.", "decided_by": "both_coders" }, { "nct": "NCT00149825", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with insomnia; depression taken as main.", "note": "Escitalopram in both arms; tests CBT for insomnia vs control therapy.", "decided_by": "both_coders" }, { "nct": "NCT00159965", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Psychogenic nonepileptic seizures (conversion disorder) taken as main; comorbid depression and PTSD also listed.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00166114", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram vs desipramine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00166296", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "pegylated interferon alfa-2a plus ribavirin", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention of interferon-induced depression in chronic hepatitis C.", "note": "Escitalopram or placebo started 2 weeks before antiviral therapy.", "decided_by": "both_coders" }, { "nct": "NCT00177216", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Primary insomnia.", "note": "Zolpidem arm (EG000) excluded. Arms' intervention lists are swapped in the record; AE groups are clear.", "decided_by": "both_coders" }, { "nct": "NCT00177294", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Late-life depression.", "note": "6 weeks of escitalopram, then partial responders randomized to IPT or care management, escitalopram 20 mg in both.", "decided_by": "both_coders" }, { "nct": "NCT00177671", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Late-life depression; dementia also listed (donepezil for cognition).", "note": "Open-label antidepressant phase, then remitters randomized to donepezil or placebo with the antidepressant kept in both.", "decided_by": "both_coders" }, { "nct": "NCT00182078", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Prevention of PTSD in injured youth; depression also listed.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00183339", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Autism in preschool children.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00200902", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine", "duloxetine", "escitalopram" ], "background": "interpersonal clinical interaction (ICI)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Medication group pools venlafaxine, duloxetine or escitalopram, chosen per participant. ICI-only group (EG002, no placebo) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00202449", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Combat PTSD nightmares and sleep disturbance.", "note": "Prazosin arm (EG000) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00209170", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "computerized CBT (Beating the Blues)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression with type 2 diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00215137", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "other_psychiatric", "indication_note": "OCD.", "note": "Open-label phase (EG000) excluded; improvers randomized to escitalopram or placebo.", "decided_by": "both_coders" }, { "nct": "NCT00215150", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Refractory social anxiety disorder.", "note": "Open-label sertraline (EG000), then randomized to ziprasidone or placebo added to sertraline.", "decided_by": "both_coders" }, { "nct": "NCT00218036", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002", "EG003" ], "placebo_groups": [ "EG004" ], "molecules": [ "citalopram" ], "background": "methadone maintenance", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Cocaine and opioid dependence.", "note": "Modafinil arms (EG000, EG001) excluded. ae_note says the trial was terminated and its data are no longer accessible; check that posted AE counts are real.", "decided_by": "both_coders" }, { "nct": "NCT00220701", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Dysthymic disorder.", "note": "Placebo arm's intervention list names escitalopram; described as an inactive comparator.", "decided_by": "both_coders" }, { "nct": "NCT00225251", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Dysthymic disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00233103", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression after traumatic brain injury.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00245635", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Pediatric body dysmorphic disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00246441", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Comorbid social anxiety disorder and alcohol use disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00247624", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with insomnia; depression taken as main.", "note": "Fluoxetine in both arms; tests eszopiclone vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00248612", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine" ], "background": "CBT", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "venlafaxine" ], "background": "progressive muscle relaxation", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Anxiety disorders with alcohol use disorder.", "note": "2x2 factorial; one comparison per therapy. All had a 1-week placebo run-in before randomized medication.", "decided_by": "both_coders" }, { "nct": "NCT00248651", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "amitriptyline", "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Functional dyspepsia.", "note": "Double-dummy.", "decided_by": "both_coders" }, { "nct": "NCT00249444", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Comorbid depression and cocaine dependence; depression taken as main.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00253890", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "trazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Poor sleep (insomnia) in opioid addiction; both other psychiatric.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00262223", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "Seeking Safety psychotherapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD with alcohol/substance use disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00271596", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Executive dysfunction in Huntington's disease, a neurological illness; arguably a DSM-5 neurocognitive disorder, but cognition rather than behavioural symptoms is targeted.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00282828", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Generalized social anxiety disorder.", "note": "Sertraline non-responders randomized to sertraline+clonazepam, a switch to venlafaxine, or sertraline+placebo; every arm gets an antidepressant and the placebo only masks clonazepam.", "decided_by": "both_coders" }, { "nct": "NCT00283842", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG004" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful diabetic peripheral neuropathy.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00285584", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depressed men who have sex with men; also aims at HIV sexual risk behaviour.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00288574", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Anorexia nervosa, relapse prevention after weight restoration.", "note": "Randomized after weight restoration, not after an antidepressant run-in, so coded acute.", "decided_by": "both_coders" }, { "nct": "NCT00292370", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Treatment-resistant PTSD.", "note": "Open-label paroxetine (EG000), then refractory patients randomized to quetiapine or placebo added to paroxetine.", "decided_by": "both_coders" }, { "nct": "NCT00296517", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "SSRI non-responders; the record doesn't say whether the SSRI was stopped.", "decided_by": "both_coders" }, { "nct": "NCT00296647", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Open-label; bupropion compared only with nicotine replacement (bupropion+lozenge vs lozenge has no placebo).", "decided_by": "both_coders" }, { "nct": "NCT00302068", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in coronary heart disease.", "note": "Exercise arm (EG000) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00302107", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD in veterans.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00304707", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people recovering from alcohol dependence.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00314249", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00318409", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine dependence in men who have sex with men; HIV also listed.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00322309", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Comorbid depression and cocaine dependence; depression taken as main.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00330187", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "contingency management", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Adolescent nicotine dependence.", "note": "2x2 factorial; one comparison per contingency-management condition.", "decided_by": "both_coders" }, { "nct": "NCT00338962", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol dependence with comorbid depression or PTSD; alcohol taken as main.", "note": "Every arm gets paroxetine or desipramine; tests naltrexone vs placebo (and SSRI vs TCA).", "decided_by": "both_coders" }, { "nct": "NCT00339079", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "medication-management supportive therapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Hypochondriasis.", "note": "CBT alone (EG000) and CBT+fluoxetine (EG003, no CBT+placebo arm) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00340379", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Psychotic depression.", "note": "Ziprasidone vs sertraline+haloperidol; no placebo arm.", "decided_by": "both_coders" }, { "nct": "NCT00354029", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Postoperative pain after hemorrhoidectomy.", "note": "Low-dose i.v. S(+)-ketamine (esketamine) given perioperatively for surgical analgesia, as an anaesthetic adjunct, not as an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT00354432", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "venlafaxine" ], "background": "none", "combination": null }, { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine" ], "background": "soy protein/isoflavones powder", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Hot flashes in men with prostate cancer.", "note": "2x2 factorial (venlafaxine vs placebo pill x soy vs placebo powder); one comparison per powder. Arm types in the record are mislabeled.", "decided_by": "both_coders" }, { "nct": "NCT00360399", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram vs duloxetine vs CBT; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00360724", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Chronic depression (dysthymia, depression NOS).", "note": "Placebo arm's intervention list names duloxetine; described as matched placebo. ae_note: other AEs assessed only in completers.", "decided_by": "both_coders" }, { "nct": "NCT00368550", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "cognitive-behavioural coping skills therapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol dependence.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00369343", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD in peri- and postmenopausal women.", "note": "Open-label extension groups (EG002, EG003) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00375973", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic fatigue syndrome.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00382291", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "CBT", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Pediatric OCD.", "note": "Regular and slow sertraline titration groups pooled.", "decided_by": "both_coders" }, { "nct": "NCT00384033", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Duloxetine reference arm is an antidepressant, pooled with both desvenlafaxine doses against placebo.", "decided_by": "both_coders" }, { "nct": "NCT00385671", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful diabetic peripheral neuropathy.", "note": "Open-label duloxetine vs pregabalin vs duloxetine+gabapentin in gabapentin inadequate responders; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00386243", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic pain in veterans.", "note": "Open-label stepped care (analgesics and unnamed co-analgesics, self-management, CBT) vs usual care; no group randomized to a named antidepressant and no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00387348", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Depression in advanced lung or gastrointestinal cancer; fatigue is also listed.", "note": "Three randomized 4+4-week sequences: placebo-placebo (EG000), placebo-escitalopram (EG001), escitalopram-placebo (EG002). The AE groups span all 8 weeks and can't be split by period, so each escitalopram group mixes 4 weeks of escitalopram with 4 of placebo. Were such groups accepted, EG002 vs EG000 would be the comparison.", "decided_by": "third_reader" }, { "nct": "NCT00401245", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG005", "EG006" ], "placebo_groups": [ "EG008" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms.", "note": "Only the double-blind taper phase has a placebo: after open-label DVS 100 mg (EG004, left out), participants were re-randomized to 2-week tapers (EG005 50 mg every other day, EG006 50 then 25 mg) or an abrupt switch to placebo (EG008). EG007 (DVS 50 mg one week, then placebo one week) left out as mixed exposure. Titration groups EG000-EG003 are all DVS, no placebo.", "decided_by": "third_reader" }, { "nct": "NCT00401726", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label venlafaxine ER in both arms; tests the Dialogues support program. Record lists no arms; AE groups are clear.", "decided_by": "both_coders" }, { "nct": "NCT00406848", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Late-life MDD.", "note": "1-week placebo lead-in for all. Rescued-placebo group (EG002, events after switching to duloxetine) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00408421", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Osteoarthritis knee pain.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00408993", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful diabetic peripheral neuropathy.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00414167", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge eating disorder taken as main; obesity also listed.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00420004", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "ly2216684", "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "LY2216684 counted as an antidepressant: the record describes it as a selective norepinephrine reuptake inhibitor for major depression. Drop EG000 if that is not accepted. Discontinuation-phase groups (EG003-EG005, the same participants after stopping) excluded.", "decided_by": "both_coders" }, { "nct": "NCT00420641", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "GSK372475 group (EG001) excluded: investigational drug whose class the record doesn't give and which it doesn't call an antidepressant. Groups include a 1-week taper.", "decided_by": "both_coders" }, { "nct": "NCT00422162", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Severe depression, inpatients.", "note": "Duloxetine 60 mg vs 120 mg; the placebo only masks the dose, and no group is off duloxetine.", "decided_by": "both_coders" }, { "nct": "NCT00429169", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with suicidal ideation or attempts.", "note": "Paroxetine vs bupropion; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00433290", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Osteoarthritis knee pain.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00439413", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "selegiline" ], "background": "weekly smoking cessation counseling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Transdermal selegiline patch (listed MAOI) for smoking cessation.", "decided_by": "both_coders" }, { "nct": "NCT00440115", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Open-label trial of disease-management intensity; every arm is offered free NRT or bupropion; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00445679", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Three desvenlafaxine doses vs paroxetine only; no placebo arm or group.", "decided_by": "both_coders" }, { "nct": "NCT00449007", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with comorbid alcohol abuse/dependence; alcohol use disorder also targeted.", "note": "Fluoxetine vs bupropion; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00452543", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with comorbid alcohol abuse/dependence; alcohol use disorder also targeted.", "note": "Escitalopram in both arms; the trial tests acamprosate vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00456521", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "intensive group lifestyle modification counseling", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Naltrexone SR/bupropion SR combination product.", "decided_by": "both_coders" }, { "nct": "NCT00457730", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Central pain in multiple sclerosis.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00465972", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Insomnia in people with HIV.", "note": "A doxepin arm is listed but has no adverse-event group; the AE groups are placebo and temazepam (a benzodiazepine) only.", "decided_by": "both_coders" }, { "nct": "NCT00471445", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": "ketamine" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chemotherapy-induced peripheral neuropathy.", "note": "Topical amitriptyline/ketamine cream (one product) vs placebo cream.", "decided_by": "both_coders" }, { "nct": "NCT00474630", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "behavioural ancillary therapy", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Obesity with type 2 diabetes.", "note": "Naltrexone SR/bupropion SR combination product.", "decided_by": "both_coders" }, { "nct": "NCT00474708", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label venlafaxine XR vs SSRIs or conventional antidepressants after a switch; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00475878", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "buprenorphine treatment for opioid dependence", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in people entering office-based buprenorphine treatment; opioid dependence is also a listed condition.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00475904", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "amitriptyline" ], "background": "none (double-dummy placebo capsules)", "combination": "ketamine" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Postherpetic neuralgia.", "note": "NP-1 cream is one amitriptyline/ketamine product. Gabapentin group EG001 excluded (non-antidepressant active comparator).", "decided_by": "both_coders" }, { "nct": "NCT00476151", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": "ketamine" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful diabetic peripheral neuropathy.", "note": "NP-1 cream is one amitriptyline/ketamine product.", "decided_by": "both_coders" }, { "nct": "NCT00477165", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Irritable bowel syndrome.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00482612", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia.", "note": "Esmirtazapine (S-enantiomer of mirtazapine, developed for insomnia) is not on the codebook list and the record does not call it an antidepressant, so no antidepressant group. If it counted: in-treatment EG000-EG002 vs EG003; follow-up groups EG004-EG007 are an off-drug period.", "decided_by": "both_coders" }, { "nct": "NCT00497081", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine use among MSM; HIV risk behaviour also targeted.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00506389", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia.", "note": "Esmirtazapine (S-enantiomer of mirtazapine, developed for insomnia) is not on the codebook list and the record does not call it an antidepressant, so no antidepressant group. If it counted: in-treatment EG000-EG001 vs EG002; follow-up groups EG003-EG005 are an off-drug period.", "decided_by": "both_coders" }, { "nct": "NCT00507728", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "smoking cessation counseling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Varenicline group EG000 excluded (not an antidepressant).", "decided_by": "both_coders" }, { "nct": "NCT00511134", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Insomnia during smoking cessation; nicotine dependence also targeted.", "note": "Bupropion (Zyban) in both arms; the trial tests eszopiclone vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00516503", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": "baclofen, ketamine" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chemotherapy-induced peripheral neuropathy.", "note": "Topical baclofen/amitriptyline/ketamine gel is one product.", "decided_by": "both_coders" }, { "nct": "NCT00519428", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram + bupropion vs each alone; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00523705", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Premenstrual syndrome in adolescents: not a DSM-5 disorder (PMDD would be depressive), though its mood symptoms are part of the target.", "note": "Luteal-phase dosing.", "decided_by": "both_coders" }, { "nct": "NCT00531947", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "selegiline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "EMSAM is transdermal selegiline; adolescents.", "decided_by": "both_coders" }, { "nct": "NCT00532779", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "behavioural ancillary therapy", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Two naltrexone doses, same bupropion SR 360 mg; combination product.", "decided_by": "both_coders" }, { "nct": "NCT00533117", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "dialectical behavior therapy", "combination": null }, { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "fluoxetine" ], "background": "supportive psychotherapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Suicidal behaviour and self-injury in borderline personality disorder.", "note": "2x2 factorial (psychotherapy x fluoxetine/placebo): one comparison per psychotherapy.", "decided_by": "both_coders" }, { "nct": "NCT00534001", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Smoking cessation; the cancer conditions are a generic listing.", "note": "Both arms get bupropion; arm I takes placebo in weeks 1-3 then bupropion, so its AE group mixes exposures. Design compares 1- vs 4-week pre-quit bupropion.", "decided_by": "both_coders" }, { "nct": "NCT00535288", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms.", "note": "Esmirtazapine (S-enantiomer of mirtazapine, developed for insomnia and hot flushes) is not on the codebook list and the record does not call it an antidepressant, so no antidepressant group. If it counted: EG001-EG004 vs EG000.", "decided_by": "both_coders" }, { "nct": "NCT00536172", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "head and neck cancer treatment", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention of depression in patients treated for head and neck cancer.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00536198", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Premenstrual dysphoric disorder, a DSM-5 depressive disorder.", "note": "Symptom-onset dosing.", "decided_by": "both_coders" }, { "nct": "NCT00536471", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Placebo group includes the protocol rescue switch to duloxetine 60 mg in months 1-3, reported in the same AE group (mixes exposures). Duloxetine EG000 itself is clean.", "decided_by": "both_coders" }, { "nct": "NCT00539240", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "nortriptyline" ], "background": "rabeprazole 20 mg once daily and placebo at dinner", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "PPI-refractory GERD.", "note": "EG001 taken as rabeprazole once daily + placebo at dinner and bedtime from its title (Arm 2) and first sentence; its appended intervention text describes the twice-daily arm (EG000's is swapped the same way). EG000 (rabeprazole twice daily) excluded: different background.", "decided_by": "both_coders" }, { "nct": "NCT00547703", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "nortriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Non-ulcer dyspepsia.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00552175", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Diabetic peripheral neuropathic pain.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00557622", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Single-blind; randomized after a run-in; paroxetine group includes a taper phase.", "decided_by": "both_coders" }, { "nct": "NCT00560612", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Secondary prevention in subthreshold PTSD.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00560833", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms.", "note": "Esmirtazapine (S-enantiomer of mirtazapine, developed for insomnia and hot flushes) is not on the codebook list and the record does not call it an antidepressant, so no antidepressant group. If it counted: EG001-EG004 vs EG000.", "decided_by": "both_coders" }, { "nct": "NCT00561574", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia in the elderly.", "note": "Two esmirtazapine doses, no placebo; esmirtazapine is also not on the codebook list nor called an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT00561821", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia in the elderly.", "note": "Esmirtazapine (S-enantiomer of mirtazapine, developed for insomnia) is not on the codebook list and the record does not call it an antidepressant, so no antidepressant group. If it counted: EG000-EG002 vs EG003 (placebo run-in and run-out in every arm).", "decided_by": "both_coders" }, { "nct": "NCT00562861", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "mood stabilizers", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Bipolar depression.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00564278", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Both arms get algorithm-guided antidepressants; the trial tests motivational interviewing; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00567255", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "behavioural ancillary therapy", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "EG000 includes NB32 non-responders re-randomized in weeks 28-44 to NB48 (more naltrexone, same bupropion 360 mg).", "decided_by": "both_coders" }, { "nct": "NCT00572234", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine use disorder.", "note": "Open-label bupropion vs treatment as usual.", "decided_by": "both_coders" }, { "nct": "NCT00574847", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Myocardial ischemia (mental stress-induced).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00578669", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "brief behavioural smoking cessation treatment and transdermal nicotine patch", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation (nicotine dependence) in smokers with elevated depressive symptoms; MDD and depression are also listed, so depressive symptoms are a second target.", "note": "Fluoxetine 20 mg or placebo (dextrose) begun 8 weeks before and continued through standard cessation treatment, 16 weeks in all.", "decided_by": "third_reader" }, { "nct": "NCT00580645", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol drinking.", "note": "Varenicline vs placebo only.", "decided_by": "both_coders" }, { "nct": "NCT00580853", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking lapse behaviour (tobacco use).", "note": "Varenicline group EG000 excluded. One-week medication lead-in before a laboratory session.", "decided_by": "both_coders" }, { "nct": "NCT00581009", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in MDD and bipolar disorder.", "note": "Open-label chronotherapy vs SSRI (plus mood stabilizer) medication; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00590863", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "escitalopram", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram + bupropion vs escitalopram + placebo (single-blind). Venlafaxine + mirtazapine EG001 excluded: different background. AE note says only SAEs were recorded.", "decided_by": "both_coders" }, { "nct": "NCT00592384", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depression or dysthymia after spinal cord injury.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00596817", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "", "note": "Open-label period group EG000 excluded.", "decided_by": "both_coders" }, { "nct": "NCT00601965", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "randomized_withdrawal", "indication": "other_psychiatric", "indication_note": "GAD in older adults.", "note": "AE groups span 12 weeks open-label and 16 weeks continuation escitalopram before the 28-week escitalopram/placebo maintenance phase, so the placebo groups mix exposures. If maintenance-only: EG000 vs EG002 (CBT) and EG001 vs EG003 (no CBT).", "decided_by": "both_coders" }, { "nct": "NCT00602290", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "methylphenidate", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Geriatric depression.", "note": "Methylphenidate + citalopram vs methylphenidate + placebo. Citalopram + placebo EG000 excluded: its only comparator is methylphenidate.", "decided_by": "both_coders" }, { "nct": "NCT00602355", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "clinical management and mothercrafting", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Postpartum depression.", "note": "IPT-alone group EG002 excluded.", "decided_by": "both_coders" }, { "nct": "NCT00602537", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Bipolar II depression.", "note": "Venlafaxine vs lithium; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00603265", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine" ], "background": "none (double-dummy placebo capsules)", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful diabetic peripheral neuropathy.", "note": "Group titles (Duloxetine EG001, Placebo EG002) follow the arm order but their descriptions are swapped; titles followed. ADL5859 group EG000 excluded.", "decided_by": "both_coders" }, { "nct": "NCT00607789", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge eating disorder with comorbid depressive disorder; both targeted.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00611975", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Healthy women (sex hormones and sexual function).", "note": "Fluoxetine vs bupropion; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00612313", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Paediatric MDD.", "note": "Fluoxetine in both arms; after 6 weeks of fluoxetine, randomized to add relapse-prevention CBT or not; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00612807", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life MDD; partner relational problem also listed.", "note": "Medication management in both arms; the trial tests marital therapy.", "decided_by": "both_coders" }, { "nct": "NCT00618956", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "AE note: both arms had a single-blind placebo discontinuation period after double-blind treatment.", "decided_by": "both_coders" }, { "nct": "NCT00619983", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "duloxetine" ], "background": "gabapentin titrated from week 8", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Diabetic neuropathic pain; chronic low back pain also listed.", "note": "Donepezil EG000 and donepezil + duloxetine EG002 excluded (donepezil; doses differ, so EG002 vs EG000 is not clean).", "decided_by": "both_coders" }, { "nct": "NCT00620776", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "GAD.", "note": "Venlafaxine XR in both arms; the trial tests adding CBT; open-label.", "decided_by": "both_coders" }, { "nct": "NCT00621517", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Restless legs syndrome, which DSM-5 counts as a sleep-wake disorder (otherwise treated as neurological).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00621777", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "randomized_withdrawal", "indication": "other_psychiatric", "indication_note": "Smoking relapse prevention in schizophrenia or bipolar disorder.", "note": "Varenicline vs placebo only.", "decided_by": "both_coders" }, { "nct": "NCT00621946", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD in patients with severe asthma.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00624013", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in patients with diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00625131", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in PTSD; both other_psychiatric.", "note": "Bupropion SR and CBT in both arms; the trial tests nicotine vs placebo patch pretreatment.", "decided_by": "both_coders" }, { "nct": "NCT00631657", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia.", "note": "Esmirtazapine (S-enantiomer of mirtazapine, developed for insomnia) is not on the codebook list and the record does not call it an antidepressant, so no antidepressant group. If it counted: EG000 vs EG001.", "decided_by": "both_coders" }, { "nct": "NCT00634283", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Healthy volunteers; 'Depression' is listed only as the research area.", "note": "Both groups receive venlafaxine; groups are defined by prior exposure (venlafaxine or placebo earlier), not randomized here.", "decided_by": "both_coders" }, { "nct": "NCT00635219", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003", "EG004" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Duloxetine active reference pooled as an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT00636649", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Night eating syndrome (DSM-5 other specified feeding or eating disorder).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00641719", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Diabetic peripheral neuropathic pain.", "note": "Open-label extension with two duloxetine doses; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00642694", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with insomnia.", "note": "Escitalopram in both arms; the trial tests ramelteon vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00643162", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life depression.", "note": "Escitalopram in both arms; the trial tests massage vs light touch; open-label.", "decided_by": "both_coders" }, { "nct": "NCT00654953", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Cocaine dependence in depressed, recently abstinent patients; depressive symptoms also targeted.", "note": "Sertraline + gabapentin group EG002 excluded.", "decided_by": "both_coders" }, { "nct": "NCT00655057", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "", "note": "Escitalopram vs CBT in depressed patients plus non-randomized healthy controls; no placebo; AE note says data are unavailable.", "decided_by": "both_coders" }, { "nct": "NCT00666757", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label duloxetine vs four generic SSRIs.", "decided_by": "both_coders" }, { "nct": "NCT00666978", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "health education counseling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in African American light smokers; the cancer conditions are a generic listing.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00668525", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00672620", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "AE groups include a 1-week post-treatment period (placebo after vortioxetine, duloxetine 30 mg taper).", "decided_by": "both_coders" }, { "nct": "NCT00672958", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00673452", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00677352", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Panic disorder.", "note": "Sertraline vs paroxetine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00683592", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00683800", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00687713", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine dependence.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00689611", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation after an acute coronary syndrome.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00696787", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "Pregabalin group EG002 excluded; study stopped after stage 1.", "decided_by": "both_coders" }, { "nct": "NCT00701675", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Late-life GAD.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00702780", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Slowing Alzheimer's disease progression; the codebook counts only behavioural symptoms of neurocognitive disorders as psychiatric.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00704379", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention of mood disorders (depression) after traumatic brain injury.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00711477", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none (fMRI scans in both)", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Naltrexone SR/bupropion SR combination product.", "decided_by": "both_coders" }, { "nct": "NCT00730691", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003", "EG004" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "GAD.", "note": "AE groups include a 1-week post-treatment period (placebo after vortioxetine, duloxetine 30 mg taper).", "decided_by": "both_coders" }, { "nct": "NCT00731120", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "GAD.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00732901", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Cocaine dependence.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00734071", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "GAD.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00735670", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Mild to moderate depressive symptoms after spinal cord injury.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00735709", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00742573", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Algorithm-guided antidepressants vs patient choice of brief IPT alone or with medication; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00744328", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline" ], "background": "none (double-dummy placebo patch)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Postpartum depression.", "note": "Transdermal estradiol group EG000 excluded.", "decided_by": "both_coders" }, { "nct": "NCT00744627", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "GAD.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00755807", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Central neuropathic pain in multiple sclerosis.", "note": "Open-label extension group EG002 excluded.", "decided_by": "both_coders" }, { "nct": "NCT00765895", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "nortriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Idiopathic gastroparesis.", "note": "Placebo arm is described as 'No treatment' but received matching placebo capsules.", "decided_by": "both_coders" }, { "nct": "NCT00767624", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with insomnia.", "note": "Antidepressant in both arms; the trial tests two insomnia therapies.", "decided_by": "both_coders" }, { "nct": "NCT00767806", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic low back pain.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00775203", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "trazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Extended-release trazodone (Contramid OAD).", "decided_by": "both_coders" }, { "nct": "NCT00786188", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms (hot flashes).", "note": "Paroxetine mesylate 7.5 mg (Brisdelle) vs sugar-pill placebo.", "decided_by": "both_coders" }, { "nct": "NCT00789854", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant major depression.", "note": "Open-label trial of quetiapine XR monotherapy vs quetiapine or lithium added to continued SSRI/venlafaxine; no placebo arm, and the antidepressant is continued prior therapy, not randomized.", "decided_by": "both_coders" }, { "nct": "NCT00794040", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "optimized methylphenidate", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Chronic irritability in youth with severe mood dysregulation (the research forerunner of DSM-5 disruptive mood dysregulation disorder, a depressive disorder); all also have ADHD. Could be read as other_psychiatric.", "note": "Open methylphenidate optimization lead-in, then randomized to add-on citalopram vs add-on placebo; citalopram starts at randomization, so acute add-on.", "decided_by": "both_coders" }, { "nct": "NCT00797797", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "Open-label milnacipran added to pregabalin vs no treatment added; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00797966", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder, adjunctive treatment.", "note": "OPC-34712 (brexpiprazole, antipsychotic) vs placebo, both added to physician-assigned antidepressant therapy after a prospective ADT phase; the antidepressant is background in every arm.", "decided_by": "both_coders" }, { "nct": "NCT00798707", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Desvenlafaxine 25 and 50 mg pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00803361", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Generalized anxiety disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00806234", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Antipsychotic-related weight gain and metabolic problems in children with psychiatric disorders (conditions list psychotic disorders).", "note": "Randomized to continue antipsychotic, switch antipsychotic, or add metformin; olanzapine/fluoxetine appears only as a possible current antipsychotic. No antidepressant arm, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00807248", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "none (double-dummy placebos)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Escitalopram 20 mg + gaboxadol placebo vs double placebo; escitalopram + gaboxadol 5/10 mg groups (EG002, EG003) left out: combined with an investigational drug placebo doesn't get.", "decided_by": "both_coders" }, { "nct": "NCT00810069", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Everyone starts escitalopram; non-improvers randomized to early switch to duloxetine vs continued escitalopram with delayed switch. Antidepressant vs antidepressant strategy trial, no placebo; some groups are post-randomization subgroups (responders/non-responders).", "decided_by": "both_coders" }, { "nct": "NCT00811252", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in elderly patients.", "note": "Vortioxetine 5 mg and duloxetine 60 mg (active reference) pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00812812", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in children and adolescents.", "note": "AE groups include the 0-3 week taper phase on both sides.", "decided_by": "both_coders" }, { "nct": "NCT00818207", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Pragmatic open trial randomizing reimbursement of self-chosen smoking cessation therapy vs no reimbursement; no randomized antidepressant or placebo.", "decided_by": "both_coders" }, { "nct": "NCT00824044", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Open-label escitalopram vs CBT; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00824291", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Arm entries are mislabeled (placebo arm lists DVS SR, other arm genotyping), but the AE groups are plainly DVS SR 50 mg vs placebo in a double-blind placebo-controlled trial.", "decided_by": "both_coders" }, { "nct": "NCT00826111", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with comorbid anxiety and insomnia.", "note": "Escitalopram in both arms, randomized to add eszopiclone or placebo; trial tests eszopiclone.", "decided_by": "both_coders" }, { "nct": "NCT00833443", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine dependence.", "note": "The sugar-pill arm's registry entry repeats the bupropion intervention and dosing text (a data-entry artifact); arm type and title make it the placebo group.", "decided_by": "both_coders" }, { "nct": "NCT00834652", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in overweight adults.", "note": "Sertraline in both arms, randomized to add metformin or placebo; trial tests metformin.", "decided_by": "both_coders" }, { "nct": "NCT00834834", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Borderline personality disorder with suicidal behavior and self-injury.", "note": "Fluoxetine (possibly switched to citalopram) with clinical management vs dialectical behavior therapy; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00839423", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Vortioxetine 5 and 10 mg and venlafaxine XL 225 mg (active reference) pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00844857", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": "olanzapine" } ], "design": "acute", "indication": "depressive", "indication_note": "Bipolar I depression in patients aged 10-17.", "note": "Olanzapine/fluoxetine combination vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00849693", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "duloxetine", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in children and adolescents.", "note": "Acute 10-week groups only; extension groups (EG004-EG007) left out, as placebo patients switched to duloxetine there.", "decided_by": "both_coders" }, { "nct": "NCT00849901", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in children and adolescents.", "note": "Acute-phase groups only; extension groups (EG003-EG005) left out, as placebo patients switched to duloxetine there.", "decided_by": "both_coders" }, { "nct": "NCT00854100", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder, adjunctive treatment.", "note": "Cariprazine (antipsychotic) vs placebo added to ongoing antidepressant after an 8-week antidepressant lead-in (EG000, everyone); the antidepressant is background in every randomized arm.", "decided_by": "both_coders" }, { "nct": "NCT00857584", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Bipolar depression, add-on to a mood stabilizer.", "note": "Open-label sertraline vs quetiapine XR, both added to lithium or valproate; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00863798", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Desvenlafaxine 10 and 50 mg pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00866294", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003", "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "paroxetine" ], "background": "none (double-dummy placebos)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Used the 'Total' groups for paroxetine CR (EG003) and IR (EG006), which match the randomized arms; the starting-dose subgroups (EG001, EG002, EG004, EG005) are subsets of them and left out to avoid double counting. AE groups include the taper phase on both sides.", "decided_by": "both_coders" }, { "nct": "NCT00872027", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention of depression after mechanical ventilation in the ICU.", "note": "AEs collected by body system only.", "decided_by": "both_coders" }, { "nct": "NCT00887224", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG004" ], "placebo_groups": [ "EG003" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Major depressive disorder, relapse prevention.", "note": "Open-label response and stability phases (EG000-EG002) left out. DB taper/post-study follow-up groups (EG005, EG006) left out too: same randomized participants in a later window, with denominators counting only those with taper/follow-up events; the DB-phase groups already include the 7-day taper.", "decided_by": "both_coders" }, { "nct": "NCT00892047", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life depression with incomplete response.", "note": "Venlafaxine XR in both arms, randomized to add aripiprazole or placebo; trial tests aripiprazole.", "decided_by": "both_coders" }, { "nct": "NCT00894166", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "nicotine patches (pre-quit non-responders)", "combination": null }, { "antidepressant_groups": [ "EG004" ], "placebo_groups": [ "EG006" ], "molecules": [ "bupropion" ], "background": "nicotine patches (post-quit lapsers)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Uncertain: no placebo is named, but masking is listed as triple, so the continued-NRT arms are taken as 'no added drug in a double-blind design'; if they were open, the trial is ineligible (no_placebo_group). Two separately randomized strata, one comparison each. NRT responders (EG000, not randomized) and varenicline groups (EG002, EG005) left out. Bupropion starts at randomization after an NRT lead-in, so acute.", "decided_by": "both_coders" }, { "nct": "NCT00894543", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal hot flashes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00898807", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "psychosocial intervention", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Agitation in Alzheimer's disease (behavioural symptoms of a neurocognitive disorder).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00905424", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with residual symptoms, augmentation.", "note": "Escitalopram in both arms after an 8-week escitalopram lead-in, randomized to add lisdexamfetamine (SPD489) or placebo; trial tests lisdexamfetamine.", "decided_by": "both_coders" }, { "nct": "NCT00909155", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Depressed patients randomized to venlafaxine ER vs fluoxetine; the no-medication control group is non-randomized healthy volunteers. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00929344", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine" ], "background": "standardized behavioral therapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol dependence.", "note": "Pregabalin group (EG001) left out: non-antidepressant active drug.", "decided_by": "both_coders" }, { "nct": "NCT00930293", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with co-occurring panic/anxiety symptoms.", "note": "Open-label citalopram in both arms with IPT-PS vs brief supportive psychotherapy; trial tests the psychotherapy. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00935818", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "varenicline and behavioral counseling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Bupropion SR vs placebo, both added to varenicline.", "decided_by": "both_coders" }, { "nct": "NCT00936299", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "cognitive behavioral therapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "ADHD in adolescents, with comorbid nicotine dependence and cannabis use disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00943618", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "varenicline and counseling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Varenicline + bupropion vs varenicline + bupropion placebo. Double-placebo group (EG002) left out: no antidepressant-only arm to pair it with (vs EG000 the groups would also differ in varenicline).", "decided_by": "both_coders" }, { "nct": "NCT00945945", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Osteoarthritis knee pain.", "note": "A drug-labeling error mixed exposures in both groups: one got duloxetine 30 mg for 1 week then placebo for 12 weeks, the other placebo for 1 week then duloxetine 60 mg for 12 weeks. Neither group is a clean antidepressant or placebo group.", "decided_by": "both_coders" }, { "nct": "NCT00946998", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depression in predialysis chronic kidney disease (depression with a medical illness).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00955474", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with psychotic features.", "note": "Quetiapine XR alone vs quetiapine XR plus an SSRI (escitalopram, sertraline or citalopram); single-blind, no SSRI placebo, so the quetiapine-only arm is not a placebo group.", "decided_by": "both_coders" }, { "nct": "NCT00958568", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Treatment-resistant depression, relapse prevention.", "note": "After open-label OFC, stabilized patients randomized to continue OFC vs fluoxetine alone; fluoxetine is in both arms and the trial tests olanzapine. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00958633", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Maintenance after remission of bipolar I depression (preventing depressive relapse); could be read as bipolar disorder outside a depressive episode (other_psychiatric).", "note": "Remitters on open-label escitalopram or bupropion XL added to antimanic drugs (EG002, left out) were randomized double-blind to continue the antidepressant 52 weeks (EG001) or stop at 8 weeks (taper from week 6, placebo by week 8; EG000). EG000 reports its 6 to 8 weeks on the antidepressant together with the later placebo period.", "decided_by": "third_reader" }, { "nct": "NCT00960986", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Open-label comparison of four duloxetine dosing strategies (start dose, with or without food); no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00961961", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "fluoxetine" ], "background": "lithium", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Bipolar depression, prevention of relapse and recurrence.", "note": "Responders to lithium + fluoxetine in Phase I (EG000, everyone; EG001 is an empty placeholder) randomized to continue fluoxetine vs switch to placebo, lithium continued. ae_note says all events were noted during the first phase, so Phase II groups may hold few or no events.", "decided_by": "both_coders" }, { "nct": "NCT00962039", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Anxiety with recurrent abdominal pain in children; the trial targets both, and abdominal pain alone would be non_psychiatric.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00962988", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in smokers with cerebrovascular disease.", "note": "Open trial randomizing cost-free cessation medication supply vs a prescription only; the medication isn't specified and no group is randomized to an antidepressant or placebo.", "decided_by": "both_coders" }, { "nct": "NCT00964886", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG003" ], "molecules": [ "desipramine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic back pain.", "note": "EG003 is an active placebo (benztropine 0.125 mg daily, meant to mimic desipramine's anticholinergic effects) that the record calls the placebo; taken as the placebo group, though a stricter reading would leave it out. CBT alone (EG001) and desipramine + CBT (EG002) left out: the CBT arm lists no pill and the trial's only placebo is mapped to arm 4 alone. If the CBT arm did get the active placebo, EG002 vs EG001 would be a second comparison.", "decided_by": "third_reader" }, { "nct": "NCT00965081", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "Duloxetine 30 mg vs placebo. The 'Duloxetine 60 mg' group (EG002) is a rescue group of participants with MDD whose depression worsened, from either arm under blinded criteria; left out as not a randomized arm. Events after rescue (likely including depression worsening) fall in EG002, not in the compared groups.", "decided_by": "both_coders" }, { "nct": "NCT00965562", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Moderate to severe premenstrual syndrome (not stated as PMDD, which DSM-5 counts as a depressive disorder; if read as PMDD, depressive).", "note": "Calcium group (EG001) left out. ae_note: AE data only for the 32 patients randomized at one site.", "decided_by": "both_coders" }, { "nct": "NCT00969150", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00969709", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Levomilnacipran ER 40, 80 and 120 mg pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT00981149", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful temporomandibular joint disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT00985504", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with residual apathy.", "note": "Switch to duloxetine vs escitalopram; antidepressant vs antidepressant, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT00986310", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Ictal hypoventilation in uncontrolled partial epilepsy.", "note": "Groups form a clean comparison, but ae_note says the PI left without entering results and no study data are available, so the AE tables may be empty; check at-risk counts before use.", "decided_by": "both_coders" }, { "nct": "NCT00991081", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Open trial of genetic feedback plus standard treatment vs standard treatment; in both arms pharmacotherapy (bupropion or nicotine patch) is assigned by genotype, not randomized. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT00994448", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine abuse in adolescents.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01000805", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with associated painful physical symptoms.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01014585", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "milnacipran" ], "background": "none (responders stratum)", "combination": null }, { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "milnacipran" ], "background": "none (non-responders stratum)", "combination": null } ], "design": "randomized_withdrawal", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "Patients on long-term milnacipran randomized to continue or switch to placebo; responders and non-responders reported as separate strata, one comparison each.", "decided_by": "both_coders" }, { "nct": "NCT01018680", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "NSAID therapy", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Osteoarthritis knee pain with suboptimal NSAID response.", "note": "Duloxetine vs placebo added to ongoing NSAIDs.", "decided_by": "both_coders" }, { "nct": "NCT01020799", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none (double-dummy placebos)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Escitalopram (active comparator) vs placebo. AZD7268 group (EG000) left out: investigational drug the record doesn't describe as an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT01027559", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depression.", "note": "Depressed patients randomized to sertraline vs CBT; healthy controls are a non-randomized, untreated group. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT01028014", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG005" ], "molecules": [ "imipramine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Urethral sphincter activity and periurethral sensation (physiologic study, apparently in volunteers without a disease condition).", "note": "Imipramine 25 mg vs lactose sham capsules for 14 days; pseudoephedrine, solifenacin, tamsulosin and cyclobenzaprine groups left out.", "decided_by": "both_coders" }, { "nct": "NCT01032018", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression after acute coronary syndrome (depression with a medical illness).", "note": "Stepped care in which patients chose problem-solving therapy, an antidepressant, both or neither vs referred usual care; no group randomized to an antidepressant, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01032083", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "none stated (usual antipsychotic care presumed)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Negative symptoms of schizophrenia.", "note": "Citalopram added to usual care vs placebo; background treatment not described in the record.", "decided_by": "both_coders" }, { "nct": "NCT01034462", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01038323", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "milnacipran" ], "background": "telephone CBT", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "CBT + milnacipran vs CBT + placebo. Education + milnacipran (EG001) left out: no education + placebo group to match.", "decided_by": "both_coders" }, { "nct": "NCT01041274", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "psychoeducation, CBT if moderately suicidal (presumed for both arms)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "First-episode schizophrenia or schizophreniform disorder; the acronym also names depression, which may be a secondary target.", "note": "Psychoeducation, CBT for moderate suicidality and fMRI are listed only under the placebo arm, but the descriptions apply to 'participants' generally, so taken as given to both arms (registry listing quirk). If only the placebo arm got them, background_differs.", "decided_by": "both_coders" }, { "nct": "NCT01048944", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "none (placebo patch/pill as double dummy)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Nicotine dependence, smoking cessation.", "note": "Bupropion SR vs placebo pill + placebo patch. Nicotine patch (EG001) and open delayed-quit control (EG003) left out.", "decided_by": "both_coders" }, { "nct": "NCT01056289", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "After 24 weeks of open-label DVS SR 50 mg (EG000, left out), randomized to continue 50 mg vs abrupt switch to placebo for 4 weeks. Taper arm (EG002: DVS 25 mg for 1 week, then placebo) left out as mixed exposure since a clean abrupt-placebo group exists; it could be added as a second discontinuation arm.", "decided_by": "both_coders" }, { "nct": "NCT01070329", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with associated painful physical symptoms.", "note": "Duloxetine group includes an optional 2-week taper.", "decided_by": "both_coders" }, { "nct": "NCT01077024", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Stimulant (cocaine or methamphetamine) dependence with nicotine dependence.", "note": "Open-label smoking-cessation package (bupropion XL plus counseling, nicotine inhaler and contingency management) added to treatment as usual vs treatment as usual alone; no placebo, and bupropion is also combined with a nicotine inhaler the control doesn't get.", "decided_by": "both_coders" }, { "nct": "NCT01077375", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia with inadequate response to duloxetine.", "note": "Switch study: duloxetine inadequate responders randomized to milnacipran vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT01085812", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "levomilnacipran" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Major depressive disorder, relapse prevention.", "note": "Open-label levomilnacipran phase (EG000) left out.", "decided_by": "both_coders" }, { "nct": "NCT01089556", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Painful diabetic neuropathy.", "note": "Duloxetine vs pregabalin, then high-dose monotherapy vs combination of both in period III; no placebo arm (placebo only as double dummy).", "decided_by": "both_coders" }, { "nct": "NCT01098318", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Rhodiola rosea herbal extract group (EG000) left out: not an antidepressant under the codebook.", "decided_by": "both_coders" }, { "nct": "NCT01101841", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms (hot flashes).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01103180", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Borderline personality disorder (self-harm).", "note": "Placebo arm's intervention entry repeats escitalopram (registry artifact); described as inert placebo.", "decided_by": "both_coders" }, { "nct": "NCT01106456", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in American Indians.", "note": "Open trial of culturally tailored vs non-tailored counseling; all participants offered pharmacotherapy (varenicline, bupropion or NRT) in both arms. No randomized antidepressant, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01108731", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Fibromyalgia ('brain fog').", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01111149", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people with schizophrenia.", "note": "Bupropion (active comparator) vs sugar pill; varenicline group (EG001) left out.", "decided_by": "both_coders" }, { "nct": "NCT01111539", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG004" ], "molecules": [ "escitalopram" ], "background": "aripiprazole (started at randomization)", "combination": null } ], "design": "other", "indication": "depressive", "indication_note": "Major depressive disorder with incomplete response to escitalopram.", "note": "After 8 weeks of single-blind escitalopram, incomplete responders randomized double-blind (blinded capsules) to aripiprazole + escitalopram, escitalopram alone, or aripiprazole alone. Aripiprazole/escitalopram (EG002) vs aripiprazole alone (EG004) differ only in continued escitalopram vs its blinded removal. Design: like a randomized withdrawal but in incomplete responders. Phase B and B+ groups (EG000, EG001, not randomized) and escitalopram alone (EG003, no matched placebo) left out.", "decided_by": "both_coders" }, { "nct": "NCT01111552", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG004" ], "placebo_groups": [ "EG003" ], "molecules": [ "escitalopram" ], "background": "aripiprazole (started at randomization)", "combination": null } ], "design": "other", "indication": "depressive", "indication_note": "Major depressive disorder with incomplete response to escitalopram.", "note": "After 8 weeks of single-blind escitalopram, incomplete responders randomized double-blind (matching placebo capsules) to escitalopram alone, aripiprazole alone, or both. Aripiprazole/escitalopram (EG004) vs aripiprazole alone (EG003) differ only in continued escitalopram vs its blinded removal. Design: like a randomized withdrawal but in incomplete responders. Phase B and B+ groups (EG000, EG001) and escitalopram alone (EG002) left out.", "decided_by": "both_coders" }, { "nct": "NCT01111565", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG004" ], "molecules": [ "escitalopram" ], "background": "aripiprazole (started at randomization)", "combination": null } ], "design": "other", "indication": "depressive", "indication_note": "Major depressive disorder with incomplete response to escitalopram.", "note": "After 8 weeks of single-blind escitalopram, incomplete responders randomized double-blind to aripiprazole + escitalopram, escitalopram alone, or aripiprazole alone. Aripiprazole/escitalopram (EG002) vs aripiprazole alone (EG004) differ only in escitalopram; placebo capsules aren't named in this record, but the phase is double-blind ('no added drug in a double-blind design'). Design: like a randomized withdrawal but in incomplete responders. EG000, EG001 (not randomized) and EG003 (no matched placebo) left out.", "decided_by": "both_coders" }, { "nct": "NCT01118780", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Generalized anxiety disorder in elderly patients.", "note": "AE tables cover the 10-week treatment period; taper reported elsewhere.", "decided_by": "both_coders" }, { "nct": "NCT01121484", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in peri- and postmenopausal women.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01124188", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with chronic back pain in older adults; back pain is a co-target.", "note": "Higher-dose venlafaxine in both arms, with problem-solving therapy vs supportive management; trial tests the psychotherapy. No placebo.", "decided_by": "both_coders" }, { "nct": "NCT01130103", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "paroxetine" ], "background": "prolonged exposure therapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Posttraumatic stress disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01138007", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "323U66 SR is GSK's code for bupropion SR (150 and 300 mg doses match); the record doesn't spell out the name but studies it as a monotherapy for MDD. Both doses pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT01140906", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Vortioxetine 15 and 20 mg and duloxetine 60 mg (active reference) pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT01145755", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine" ], "background": "none (double-dummy placebos)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Duloxetine (active comparator) vs placebo; AZD2066 group (EG000) left out: investigational drug the record doesn't describe as an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT01153009", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Vortioxetine 15 and 20 mg and duloxetine 60 mg pooled vs placebo; each arm's final week is a blinded taper/discontinuation week (vortioxetine to placebo, duloxetine to 30 mg).", "decided_by": "both_coders" }, { "nct": "NCT01163266", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Vortioxetine 10 and 20 mg pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT01178671", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "sertraline (started in both arms)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Posttraumatic stress disorder.", "note": "Mirtazapine vs sugar pill, both with flexible-dose sertraline; the background is itself an antidepressant given to both sides.", "decided_by": "both_coders" }, { "nct": "NCT01179516", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Vortioxetine 10 and 15 mg pooled vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT01179568", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "grief-focused clinical management", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "citalopram" ], "background": "complicated grief treatment (psychotherapy)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Complicated grief (prolonged grief; trauma- and stressor-related).", "note": "2x2 factorial: citalopram vs placebo within each psychotherapy condition.", "decided_by": "both_coders" }, { "nct": "NCT01179672", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Diabetic peripheral neuropathic pain.", "note": "12-week treatment groups used; 1-week taper groups (EG002, EG003) left out because they are the same randomized participants in a later window and would double count them in one comparison.", "decided_by": "both_coders" }, { "nct": "NCT01189812", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depressive mood disorders (MDD, dysthymia, depression NOS), some with borderline personality disorder.", "note": "Citalopram 20 mg in both arms with lithium vs placebo; trial tests lithium.", "decided_by": "both_coders" }, { "nct": "NCT01206478", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "megestrol from visit 2 (week 10), both arms", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic oral food refusal in children aged 9 months to 8 years, read as a feeding disorder (DSM-5 feeding and eating disorders, avoidant/restrictive food intake); a medical reading as a paediatric feeding problem would make it non_psychiatric.", "note": "Amitriptyline 1 mg/kg vs matching placebo; both arms get megestrol from visit 2, so it is background. The placebo arm is typed active comparator only because of the megestrol.", "decided_by": "third_reader" }, { "nct": "NCT01219673", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "none", "combination": null }, { "antidepressant_groups": [ "EG005" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "armodafinil", "combination": null }, { "antidepressant_groups": [ "EG006" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "minocycline", "combination": null }, { "antidepressant_groups": [ "EG007" ], "placebo_groups": [ "EG004" ], "molecules": [ "bupropion" ], "background": "armodafinil + minocycline", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Symptom burden from chemoradiation for head and neck cancer.", "note": "2x2x2 factorial (armodafinil, minocycline, bupropion) with triple masking; one bupropion-vs-no-bupropion comparison per background. Matching placebos for absent drugs aren't spelled out per arm, taken from the triple-blind design.", "decided_by": "both_coders" }, { "nct": "NCT01223001", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention/treatment of depression after traumatic brain injury (also cognitive recovery).", "note": "ae_note says no adverse events of any type occurred.", "decided_by": "both_coders" }, { "nct": "NCT01225068", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic neuropathic low back pain.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01226511", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Generalized anxiety disorder in children and adolescents.", "note": "Acute 10-week groups only; extension groups (placebo switched to duloxetine) and taper groups (Placebo-Taper mixes former duloxetine and placebo patients) left out.", "decided_by": "both_coders" }, { "nct": "NCT01235338", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Healthy volunteers (drug-interaction study).", "note": "Phase 1 open-label pharmacokinetic interaction study of lisdexamfetamine and venlafaxine XR in two dosing sequences; AE groups are dosing periods, not randomized arms, and there is no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01237587", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Juvenile primary fibromyalgia in adolescents.", "note": "Acute 13-week groups only; open-label extension and taper groups (EG002-EG005) left out (placebo patients switched to duloxetine; Placebo/Placebo-Taper mixes former duloxetine 30 mg and placebo patients).", "decided_by": "both_coders" }, { "nct": "NCT01254305", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran", "paroxetine", "sertraline", "citalopram", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "fatigue associated with MDD", "note": "SSRI group (one of paroxetine, sertraline, citalopram or fluoxetine) is an antidepressant active comparator, pooled with levomilnacipran against placebo.", "decided_by": "both_coders" }, { "nct": "NCT01255787", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Active arms took blinded placebo for a 2-week discontinuation after 8 weeks; groups cover the whole blinded period.", "decided_by": "both_coders" }, { "nct": "NCT01265550", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "PPI-refractory GERD", "note": "Medical arm got omeprazole plus baclofen and/or desipramine (stepped, so the group mixes exposures) vs omeprazole plus placebo; baclofen is not given to the control. EG003 'All Enrolled' is pre-randomization; surgery arm irrelevant.", "decided_by": "both_coders" }, { "nct": "NCT01286402", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation in pregnancy", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01288079", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to prior antidepressant (monotherapy study)", "note": "TC-5214 (S-mecamylamine) groups EG000/EG001 left out: investigational drug of another class, not described as an antidepressant in the record.", "decided_by": "both_coders" }, { "nct": "NCT01288937", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "idiopathic peripheral neuropathy pain", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01299805", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "healthy volunteers (pharmacodynamic study); no condition treated", "note": "Phase 1, single-blind, 14 days.", "decided_by": "both_coders" }, { "nct": "NCT01299896", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation", "note": "Usual care vs coordinated care; no drug randomized (cessation medication only as part of usual care).", "decided_by": "both_coders" }, { "nct": "NCT01302964", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "anxiety in children with pervasive developmental disorders (autism spectrum)", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01303861", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline (smokers not responding to pre-quit nicotine patch)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "nicotine dependence", "note": "Patch non-responders assigned to varenicline vs varenicline+bupropion; the record names no bupropion placebo, but masking is double, so varenicline alone is taken as no added drug in a double-blind design. Randomized after a pre-quit patch phase (adaptive). Patch-responder groups EG001/EG002 and EG004 (dropped before assignment) left out.", "decided_by": "both_coders" }, { "nct": "NCT01312922", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "citalopram" ], "background": "pipamperone", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "PNB01 is a fixed-dose pipamperone+citalopram product; the quadruple-masked pipamperone-alone arm is taken as the no-added-citalopram comparator with pipamperone as shared background, assuming the same pipamperone dose (record gives none). Not a codebook 'combination' since the comparator also gets pipamperone. Citalopram arm EG001 left out: no placebo counterpart.", "decided_by": "both_coders" }, { "nct": "NCT01316302", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "generalized social anxiety disorder", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01324700", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none (high-severity stratum)", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "escitalopram" ], "background": "none (low-severity stratum)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "depression in inner-city asthma patients (depression with a medical illness)", "note": "Randomized within severity strata; one comparison per stratum (could be pooled).", "decided_by": "both_coders" }, { "nct": "NCT01328002", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "non_psychiatric", "indication_note": "juvenile primary fibromyalgia", "note": "EG000 is the open-label milnacipran period, left out.", "decided_by": "both_coders" }, { "nct": "NCT01330030", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "transdermal selegiline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Tobacco use disorder (nicotine dependence).", "note": "Selegiline 6 mg/24 h transdermal patch vs matching placebo patch for 8 weeks.", "decided_by": "third_reader" }, { "nct": "NCT01330043", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "smoking cessation", "note": "Everyone got open-label bupropion + nicotine patch + CBT (varenicline if still smoking at week 10); the randomized contrast is extended vs standard-length CBT, timing of randomization unclear.", "decided_by": "both_coders" }, { "nct": "NCT01337700", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "autism spectrum disorder in adults", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01347541", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD in injured trauma survivors", "note": "Stepped care (CBT, motivational interviewing, unspecified anti-anxiety medication) vs open-label standard care; no placebo and no named antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT01348542", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "chronic insomnia", "note": "Open-label trazodone vs CBT; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01354314", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "paroxetine" ], "background": "none (fluconazole placebo)", "combination": null }, { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "paroxetine" ], "background": "fluconazole", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "HIV-associated neurocognitive disorder (cognitive impairment); coded non_psychiatric because the codebook counts only behavioural symptoms of neurocognitive disorders as psychiatric, though DSM-5 lists NCD due to HIV", "note": "2x2 factorial paroxetine x fluconazole with matching placebos; one comparison per fluconazole background.", "decided_by": "both_coders" }, { "nct": "NCT01355081", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01361308", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "menopausal vasomotor symptoms", "note": "Brisdelle is paroxetine mesylate.", "decided_by": "both_coders" }, { "nct": "NCT01364649", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "well-treated MDD with SSRI-induced sexual dysfunction (switch study; sexual function is the primary target)", "note": "Vortioxetine vs escitalopram only.", "decided_by": "both_coders" }, { "nct": "NCT01368432", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "depression after traumatic brain injury, also other comorbid psychiatric conditions", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01371734", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "pediatric MDD (7-17 years)", "note": "Includes a 1-week blinded taper for those not entering the extension.", "decided_by": "both_coders" }, { "nct": "NCT01372150", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002", "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "pediatric MDD (7-17 years)", "note": "Fluoxetine is the active reference arm (an antidepressant), pooled with desvenlafaxine.", "decided_by": "both_coders" }, { "nct": "NCT01377194", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "EG002's description says 40 mg but its title says 80 mg; it is the 80 mg arm.", "decided_by": "both_coders" }, { "nct": "NCT01390246", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "smoking cessation counseling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "tobacco use disorder in pregnancy", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01393522", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "chronic migraine", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01398514", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "experimental fear-conditioning model for preventing trauma-related fear and anxiety; participants apparently without a disorder", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01406223", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline after pre-quit nicotine patch; placebo patch", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "nicotine dependence", "note": "Varenicline arm got placebo bupropion. Nicotine-patch groups EG001/EG003 (placebo bupropion, no antidepressant) left out.", "decided_by": "both_coders" }, { "nct": "NCT01409382", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "pregnancy outcomes, neonatal hypoglycemia", "note": "Lifestyle counseling vs standard prenatal care; no drug arms (groups split mothers and babies).", "decided_by": "both_coders" }, { "nct": "NCT01418209", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "menopausal vasomotor symptoms", "note": "Low-dose estradiol group EG000 left out (active comparator, not an antidepressant).", "decided_by": "both_coders" }, { "nct": "NCT01421342", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to antidepressant", "note": "Open-label switch to bupropion vs augmentation with bupropion vs augmentation with aripiprazole; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01422213", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD (cognitive dysfunction as outcome)", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01427608", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "remitted psychotic depression", "note": "Remitted patients on sertraline+olanzapine randomized to continue olanzapine or switch it to placebo; sertraline continued in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01432457", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Includes a 1-week taper (50 mg arm tapered on placebo).", "decided_by": "both_coders" }, { "nct": "NCT01436149", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to prospective antidepressant", "note": "Lisdexamfetamine vs placebo added to escitalopram, sertraline, venlafaxine XR or duloxetine in both arms; add-on randomized after a prospective antidepressant phase.", "decided_by": "both_coders" }, { "nct": "NCT01436162", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to prospective antidepressant", "note": "Lisdexamfetamine vs placebo added to escitalopram, sertraline, venlafaxine XR or duloxetine in both arms; add-on randomized after a prospective antidepressant phase.", "decided_by": "both_coders" }, { "nct": "NCT01441440", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01451606", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "chronic pelvic pain", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01456936", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "none (triple-dummy placebos)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation in smokers with and without a psychiatric history", "note": "Varenicline (EG000) and nicotine patch (EG002) groups left out: active comparators, not antidepressants. AEs collected to 30 days after last dose.", "decided_by": "both_coders" }, { "nct": "NCT01469377", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD, adjunctive treatment", "note": "Cariprazine vs placebo added to the ongoing antidepressant in every arm.", "decided_by": "both_coders" }, { "nct": "NCT01471379", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "irritable bowel syndrome", "note": "Placebo group EG002 switched to milnacipran 50 mg BID at week 6 and its AE group covers both phases (mixes exposures); the other two groups are both milnacipran, so no clean placebo group remains.", "decided_by": "both_coders" }, { "nct": "NCT01473381", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone", "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Citalopram is the active reference (an antidepressant), pooled; double-dummy design.", "decided_by": "both_coders" }, { "nct": "NCT01473394", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01474746", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "young children (2-5 years) with fragile X syndrome, a genetic neurodevelopmental condition; coded as neurodevelopmental", "note": "Low-dose liquid sertraline for 6 months.", "decided_by": "both_coders" }, { "nct": "NCT01479829", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "bipolar depression", "note": "Celecoxib vs placebo added to escitalopram in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01488071", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to prior antidepressant", "note": "Vortioxetine vs agomelatine only.", "decided_by": "both_coders" }, { "nct": "NCT01510457", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "knee osteoarthritis pain (mood changes also studied)", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01524133", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline" ], "background": "prolonged exposure therapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD in OEF/OIF veterans", "note": "Sertraline + enhanced medication management (EG000) left out: no placebo arm with the same co-intervention.", "decided_by": "both_coders" }, { "nct": "NCT01533753", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "hot flashes in men with prostate cancer", "note": "Open-label gabapentin vs venlafaxine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01535573", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "cocaine dependence", "note": "Official title mentions a 'serotonin medication combination', but arms and groups show only citalopram 20/40 mg vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT01537068", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "chronic depression / dysthymia", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01545843", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Fluoxetine in every arm; the randomized contrast is the sleep deprivation schedule.", "decided_by": "both_coders" }, { "nct": "NCT01552057", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "fibromyalgia", "note": "Includes a 1-week blinded taper.", "decided_by": "both_coders" }, { "nct": "NCT01558700", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "osteoarthritis pain", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01564862", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "vortioxetine", "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD (cognitive dysfunction as outcome)", "note": "Duloxetine is the active reference (an antidepressant), pooled.", "decided_by": "both_coders" }, { "nct": "NCT01569126", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG004", "EG005" ], "placebo_groups": [ "EG003" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "healthy volunteers (phase 1 PK study); no condition treated", "note": "LY110140 is fluoxetine. Multiple-dose cohorts 4 and 5 share placebo group EG003; single-dose cohorts EG000-EG002 have no placebo group reported and are left out.", "decided_by": "both_coders" }, { "nct": "NCT01571453", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Vortioxetine vs venlafaxine XR only.", "decided_by": "both_coders" }, { "nct": "NCT01574183", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "marijuana dependence", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01581281", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "pediatric migraine prevention", "note": "Topiramate group EG000 left out (active comparator).", "decided_by": "both_coders" }, { "nct": "NCT01592695", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking in rural veterans with comorbid depression, alcohol use or obesity; main target smoking", "note": "Tailored vs enhanced standard care; both arms could get bupropion, varenicline or NRT by preference, so no group was randomized to an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT01598298", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "aromatase inhibitor therapy", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "aromatase inhibitor-associated musculoskeletal pain in early breast cancer", "note": "Only AEs judged related to study drug are reported.", "decided_by": "both_coders" }, { "nct": "NCT01601704", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "weight management program", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "overweight/obesity with cardiovascular risk factors", "note": "NB32 is the naltrexone SR/bupropion SR combination product. Safety data from the database lock after the 50% interim analysis.", "decided_by": "both_coders" }, { "nct": "NCT01608295", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "geriatric MDD", "note": "Vilazodone vs paroxetine only.", "decided_by": "both_coders" }, { "nct": "NCT01609348", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "depression in Alzheimer's disease", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01611155", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine" ], "background": "FOLFOX chemotherapy", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "prevention of oxaliplatin-induced neuropathy", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01621009", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "counseling or medication checks only (pooled 2x2 factorial)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "tobacco dependence", "note": "2x2 bupropion x counseling factorial; AE groups pool the counseling arms on each side, so both sides carry the same randomized counseling mix.", "decided_by": "both_coders" }, { "nct": "NCT01629966", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "generalized anxiety disorder", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01635218", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "homeopathic placebo drops (double-dummy)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "moderate to severe depression in peri- and postmenopausal women", "note": "Individualized homeopathy group EG000 left out (not an antidepressant).", "decided_by": "both_coders" }, { "nct": "NCT01651442", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "primary and psychiatric-comorbid insomnia", "note": "Sequenced open-label treatments: behavioural therapy or zolpidem first, then cognitive therapy or trazodone (second-stage arm); no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01658228", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "depression with mild cognitive impairment; the randomized add-on (donepezil) targets cognition", "note": "After 16 weeks of open-label citalopram or venlafaxine, randomized to add-on donepezil vs placebo; the antidepressant continues in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01662297", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "insomnia in veterans with mental health and substance use disorders", "note": "Open-label stay on quetiapine vs switch to trazodone; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01680900", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "menopausal hot flashes", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01681849", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD after childhood abuse", "note": "Both arms entered 3 months of open-label paroxetine after the 3-month blinded phase, and the AE groups describe both phases, so the placebo group mixes placebo and paroxetine exposure. PTSD-negative group EG002 is not randomized.", "decided_by": "both_coders" }, { "nct": "NCT01687478", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "treatment-resistant depression", "note": "Olanzapine vs placebo added to fluoxetine in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01691105", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "hospitalized smokers", "note": "Health-IT order set vs academic detailing; bupropion is only a prescribing option; AEs were not assessed.", "decided_by": "both_coders" }, { "nct": "NCT01703039", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Riluzole vs placebo added to sertraline 100 mg in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01714310", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "open-label lisdexamfetamine", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "severe mood dysregulation in youth (chronic irritability; its DSM-5 successor, disruptive mood dysregulation disorder, is a depressive disorder); stimulant lead-in suggests ADHD comorbidity", "note": "After 4 weeks of open-label lisdexamfetamine, randomized to adjunctive fluoxetine vs placebo; open lead-in group EG002 left out.", "decided_by": "both_coders" }, { "nct": "NCT01714323", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "hospitalized smokers after discharge", "note": "Sustained care (free medication of choice: NRT, bupropion or varenicline, plus IVR counseling) vs standard care; no group randomized to an antidepressant, and no systematic AE assessment.", "decided_by": "both_coders" }, { "nct": "NCT01715805", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD, adjunctive treatment", "note": "Cariprazine vs placebo added to ADT after an 8-week ADT + single-blind placebo lead-in; lead-in (EG000) and continued-treatment (EG003) groups are not randomized arms.", "decided_by": "both_coders" }, { "nct": "NCT01740726", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "adolescent MDD", "note": "Behavioral activation vs fluoxetine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01748955", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with suicide attempt or ideation", "note": "Bupropion XL vs paroxetine CR only.", "decided_by": "both_coders" }, { "nct": "NCT01764386", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "overweight/obesity", "note": "Open-label naltrexone/bupropion + comprehensive lifestyle program vs usual care (self-directed lifestyle), so background also differs. EG002 'All Subjects' spans the uncontrolled period.", "decided_by": "both_coders" }, { "nct": "NCT01766401", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "generalized anxiety disorder", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01777581", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "milnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "lumbosacral radicular pain", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01778686", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "healthy volunteers (PET radioligand evaluation)", "note": "IV citalopram given with oral pindolol vs placebo for both; pindolol not given to the placebo group. Tryptophan-depletion group EG002 is not an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT01787240", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01797380", "eligible": false, "exclusion_reason": "other", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depressive symptoms and fatigue in HIV-seropositive women (depression with a medical illness).", "note": "Terminated before any participant was treated; no participants analyzed, so both AE groups are empty. By design escitalopram (EG001) vs placebo (EG000) would be a clean comparison.", "decided_by": "third_reader" }, { "nct": "NCT01802385", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "amphotericin + fluconazole", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "HIV-associated cryptococcal meningitis", "note": "Placebo arm is typed NO_INTERVENTION but described as placebo under quadruple masking; EG000's description repeats the sertraline text, apparently copied. Non-serious AE terms can't be separated.", "decided_by": "both_coders" }, { "nct": "NCT01802437", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "adolescent depression", "note": "Adaptive (SMART) design: IPT first, non-responders re-randomized to added fluoxetine vs more IPT; no placebo, and the AE groups (by decision point) mix fluoxetine and non-fluoxetine participants.", "decided_by": "both_coders" }, { "nct": "NCT01803711", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD in patients with a medical illness", "note": "Omega-3 vs placebo added to desvenlafaxine in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01806779", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline after 1-week nicotine patch run-in", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "nicotine dependence", "note": "Double-masked; the varenicline-alone group names no bupropion placebo, taken as no added drug in a double-blind design. EG002 is the pre-randomization patch run-in of all participants.", "decided_by": "both_coders" }, { "nct": "NCT01808612", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Treatment-period groups only; discontinuation-period groups EG003-EG005 (everyone on placebo) left out.", "decided_by": "both_coders" }, { "nct": "NCT01838681", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "MDD with inadequate response to antidepressant", "note": "Brexpiprazole vs placebo added to open-label ADT in both arms; maintenance-of-efficacy design inferred from the title.", "decided_by": "both_coders" }, { "nct": "NCT01844115", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "generalized anxiety disorder", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01846182", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Gulf War illness (chronic multisymptom illness)", "note": "Pregabalin group EG001 left out (active comparator). ae_note says event collection was inadequate and the data unreliable.", "decided_by": "both_coders" }, { "nct": "NCT01850589", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation in vascular surgery patients", "note": "Conservative vs aggressive cessation programs; pharmacotherapy offered, not randomized.", "decided_by": "both_coders" }, { "nct": "NCT01855919", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "chronic low back pain", "note": "Includes a 1-week taper.", "decided_by": "both_coders" }, { "nct": "NCT01856270", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "prevention of post-traumatic headache after TBI", "note": "Open-label amitriptyline started at once vs at day 30 (delayed start); no placebo, and the delayed group later takes amitriptyline.", "decided_by": "both_coders" }, { "nct": "NCT01871506", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation in cancer patients", "note": "Standard vs intensive counseling; cessation medication optional, not randomized.", "decided_by": "both_coders" }, { "nct": "NCT01878292", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "adolescent MDD", "note": "", "decided_by": "both_coders" }, { "nct": "NCT01901848", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD with smoking", "note": "Bupropion and NRT in both arms; the trial tests adding cognitive processing therapy.", "decided_by": "both_coders" }, { "nct": "NCT01902004", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "geriatric depression with mild cognitive impairment", "note": "Memantine vs placebo added to open-label escitalopram in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01919216", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Comparison within the blinded placebo track; open-label citalopram track EG000 left out (differs in blinding).", "decided_by": "both_coders" }, { "nct": "NCT01931202", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "late-life MDD", "note": "Open-label escitalopram group EG002 left out (differs in blinding).", "decided_by": "both_coders" }, { "nct": "NCT01931475", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic pain due to osteoarthritis.", "note": "Double-blind groups only. Extension groups (EG002, EG003) are open-label duloxetine for everyone; taper groups left out (EG005 mixes placebo taper and duloxetine taper after the extension).", "decided_by": "both_coders" }, { "nct": "NCT01933919", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluvoxamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Paediatric obsessive-compulsive disorder.", "note": "First (double-blind) phase only; second-phase groups (EG002, EG003) are the open-label fluvoxamine extension.", "decided_by": "both_coders" }, { "nct": "NCT01943435", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Lumbar spinal stenosis.", "note": "Medical-care arm gets physician-individualized NSAIDs, analgesics or optional antidepressants (no one randomized to a named antidepressant); comparators are exercise and manual therapy; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT01977729", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Child and adolescent anxiety disorders.", "note": "Both arms get sertraline (CBT plus sertraline vs switch to sertraline alone); the contrast is continued CBT. Open-label, no placebo. Randomized in a second phase after first-phase CBT.", "decided_by": "both_coders" }, { "nct": "NCT01987960", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Post-traumatic stress disorder.", "note": "Brexpiprazole vs placebo, both added to open-label paroxetine or sertraline; the antidepressant is background in both arms.", "decided_by": "both_coders" }, { "nct": "NCT01993017", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depressive symptoms after acute coronary syndrome (depression with a medical illness).", "note": "Randomized to depression-screening strategies; only screen-positive participants were offered CBT or antidepressant medication by preference, so no group was randomized to an antidepressant. The 'no screen' arm is no intervention, not placebo.", "decided_by": "both_coders" }, { "nct": "NCT01998958", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG019", "EG020", "EG021" ], "placebo_groups": [ "EG000" ], "molecules": [ "esketamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression.", "note": "Doubly-randomized design: Period 1 groups used (esketamine 14/28/56/84 mg vs placebo). Period 2 re-randomization of placebo non-responders left out: same people as the Period 1 placebo group, EG005 and EG010 descriptions mix in Panel B esketamine responders, and EG007 pools all Period 2 placebo. Open-label and follow-up groups excluded. Record names no background antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT01999920", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "vilazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Separation anxiety disorder in adults.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02005601", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "total knee arthroplasty with usual perioperative care", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Sub-acute pain after total knee arthroplasty.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02014363", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with unsatisfactory response to SSRIs.", "note": "ETS6103 (investigational, low and high dose; the record tests its antidepressant activity) vs amitriptyline; no placebo arm. Randomized after a citalopram lead-in.", "decided_by": "both_coders" }, { "nct": "NCT02015546", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder, switching from SSRIs/SNRIs.", "note": "Three vilazodone dose-initiation strategies; every arm gets vilazodone, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02017535", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Adolescent depression (continuation phase).", "note": "Continuation-phase groups defined by acute-phase treatment and response (IPT-A alone, IPT-A with continued, new, or increased fluoxetine); no placebo, single-blind, groups not a clean randomized drug contrast.", "decided_by": "both_coders" }, { "nct": "NCT02021669", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in people with cardiac risk factors.", "note": "Omega-3 (EPA) vs corn-oil placebo, both with sertraline 50 mg daily; the trial tests omega-3.", "decided_by": "both_coders" }, { "nct": "NCT02046564", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "ASC-01 (aripiprazole/sertraline 100 mg) vs placebo/sertraline 100 mg: both arms get sertraline 100 mg; the contrast is aripiprazole.", "decided_by": "both_coders" }, { "nct": "NCT02050308", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation (tobacco use).", "note": "Both web-program arms offer a choice of varenicline, bupropion, or nicotine replacement; no one was randomized to bupropion and there is no placebo. The trial tests web content.", "decided_by": "both_coders" }, { "nct": "NCT02052739", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Super-refractory status epilepticus.", "note": "Open-label brexanolone (SAGE-547) standard vs high dose as adjunctive therapy; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02080832", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Cocaine dependence.", "note": "Citalopram 20 mg and 40 mg pooled against placebo.", "decided_by": "both_coders" }, { "nct": "NCT02082392", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Escitalopram vs placebo crossed with visit frequency, but the adverse-event groups are by visit frequency only and each pools escitalopram and placebo participants.", "decided_by": "both_coders" }, { "nct": "NCT02088697", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Healthy volunteers (bioequivalence study).", "note": "Single-dose crossover bioequivalence of 'ASC-01 placebo' (aripiprazole 0 mg/sertraline 100 mg) vs sertraline tablet; both groups get sertraline 100 mg, no true placebo.", "decided_by": "both_coders" }, { "nct": "NCT02090998", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Transformed (chronic) migraine.", "note": "Open-label amitriptyline vs sphenopalatine ganglion block with lidocaine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02111798", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG003" ], "placebo_groups": [ "EG000", "EG002" ], "molecules": [ "bupropion" ], "background": "contingency management (abstinence-initiation or relapse-prevention incentives assigned by week 1-6 urine results)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Cocaine dependence.", "note": "Bupropion XL vs placebo randomized at week 2; the contingency-management track was assigned by urine results, not randomized, so the two strata are pooled on each side to keep the randomized contrast.", "decided_by": "both_coders" }, { "nct": "NCT02133001", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "esketamine" ], "background": "standard-of-care oral antidepressant chosen by the treating physician", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with imminent suicide risk.", "note": "Double-blind groups only; follow-up phase groups (EG002, EG003) are the same participants after treatment ended.", "decided_by": "both_coders" }, { "nct": "NCT02161458", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG002", "EG003" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Cognitively normal older adults; CSF amyloid-beta (Alzheimer's prevention research).", "note": "Escitalopram 20 mg 2 weeks, 30 mg 8 weeks and 20 mg 8 weeks pooled; the placebo group itself pools 2- and 8-week durations.", "decided_by": "both_coders" }, { "nct": "NCT02181231", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life depression with incomplete response.", "note": "Buprenorphine vs placebo, both added to venlafaxine XR that every participant stays on.", "decided_by": "both_coders" }, { "nct": "NCT02185131", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Co-occurring major depressive disorder and alcohol use disorder; both targeted, depression given as main.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02188459", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation (nicotine dependence) in pregnant women.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02191397", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "Bupropion XL vs escitalopram under double dummy; both arms are antidepressants and there is no placebo arm.", "decided_by": "both_coders" }, { "nct": "NCT02208466", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "sham rTMS", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Motor recovery after acute stroke.", "note": "Sham rTMS plus fluoxetine vs sham rTMS plus placebo. Active rTMS plus fluoxetine group (EG000) left out: the placebo group gets no active rTMS.", "decided_by": "both_coders" }, { "nct": "NCT02229539", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "doxepin" ], "background": "radiotherapy with or without chemotherapy", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Oral mucositis pain during radiotherapy.", "note": "Doxepin given as an oral rinse. DLA rinse group (EG002) is an active comparator, left out.", "decided_by": "both_coders" }, { "nct": "NCT02229825", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Severe major depression in hospitalized patients.", "note": "Duloxetine 60 mg vs 120 mg; placebo capsules only for blinding, no placebo arm.", "decided_by": "both_coders" }, { "nct": "NCT02235064", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention of postpartum depression.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02238977", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depression in end-stage renal disease on hemodialysis.", "note": "Open-label bupropion vs fluoxetine (no one enrolled in the fluoxetine arm); no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02245308", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Tobacco use disorder in homeless veterans.", "note": "Tele-health package (nicotine replacement, mobile contingency management, counselling, possible bupropion) vs referral to standard care; no one randomized to bupropion and no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02248480", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic knee osteoarthritis pain.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02260388", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Cryptogenic sensory polyneuropathy (neuropathic pain).", "note": "Open-label nortriptyline vs duloxetine vs pregabalin vs mexiletine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02288325", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "levomilnacipran" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Major depressive disorder (relapse prevention).", "note": "Open-label run-in/stabilization group (EG000) left out; comparison is the double-blind randomized phase.", "decided_by": "both_coders" }, { "nct": "NCT02317744", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge eating disorder in people with obesity; the eating disorder is taken as main.", "note": "Naltrexone 50 mg plus bupropion 300 mg daily vs pill placebo. Called a combination, but those are each drug's own standard doses, not ones the fixed-dose naltrexone-bupropion product gives, so it reads as two drugs taken together; the placebo group gets neither. If it were the one product, EG000 vs EG001 would be a comparison with combination naltrexone.", "decided_by": "third_reader" }, { "nct": "NCT02327013", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Adult ADHD.", "note": "Sequential parallel comparison design: each vortioxetine group adds placebo non-responders re-randomized to vortioxetine in Stage 2 (6 weeks placebo then vortioxetine), and the placebo group keeps only those who stayed on placebo, so every group mixes stages and exposures.", "decided_by": "both_coders" }, { "nct": "NCT02332291", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Late-life major depressive disorder.", "note": "Blinded 8-week phase only; open-label bupropion for non-remitters (EG002) left out.", "decided_by": "both_coders" }, { "nct": "NCT02357849", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Attenuated psychosis syndrome (psychosis prevention).", "note": "Fluoxetine vs aripiprazole; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02358343", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in end-stage renal disease.", "note": "Open-label sertraline vs cognitive behavioral therapy; adverse events only for these two arms; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02371980", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002", "EG003", "EG004" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Major depressive disorder (relapse prevention).", "note": "Open-label vortioxetine 10 mg period (EG000) left out. The 20 mg arm is mislabelled PLACEBO_COMPARATOR in the arms list but its group (EG004) is vortioxetine 20 mg.", "decided_by": "both_coders" }, { "nct": "NCT02372799", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Paediatric major depressive disorder.", "note": "Fluoxetine is an antidepressant active control, pooled with vilazodone against placebo.", "decided_by": "both_coders" }, { "nct": "NCT02385799", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Autism spectrum disorder in young children.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02389465", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life major depression (inflammation substudy).", "note": "Depressed participants all get escitalopram plus celecoxib or placebo; the trial tests celecoxib. Healthy-control group (EG000) not randomized. EG001 'Placebo' and EG002 'Escitalopram' descriptions overlap (both escitalopram with a placebo pill).", "decided_by": "both_coders" }, { "nct": "NCT02389712", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Bipolar depression.", "note": "Open-label fluoxetine vs lamotrigine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02389816", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02407704", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in younger and older adults.", "note": "Venlafaxine XR in every arm, with or without aerobic exercise (groups split by age); the trial tests exercise. Open-label, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02417064", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "esketamine" ], "background": "newly started open-label oral antidepressant (duloxetine, escitalopram, sertraline or venlafaxine XR)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression.", "note": "Esketamine 56 and 84 mg pooled against intranasal placebo (arm labelled active comparator only because of the oral antidepressant). Follow-up phase groups (EG003-EG005) left out.", "decided_by": "both_coders" }, { "nct": "NCT02417935", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Diabetic peripheral neuropathic pain.", "note": "Duloxetine vs pregabalin under double dummy; no placebo arm.", "decided_by": "both_coders" }, { "nct": "NCT02418585", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "esketamine" ], "background": "newly started open-label oral antidepressant (duloxetine, escitalopram, sertraline or venlafaxine XR)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression.", "note": "Double-blind induction groups only; follow-up phase groups (EG002, EG003) left out.", "decided_by": "both_coders" }, { "nct": "NCT02420015", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people with schizophrenia.", "note": "Both arms get nicotine replacement, bupropion and counselling; iCOMMIT adds mobile contingency management and apps. Open-label, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02422186", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "esketamine" ], "background": "newly started open-label oral antidepressant (duloxetine, escitalopram, sertraline or venlafaxine XR)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression in older adults.", "note": "Double-blind induction groups only; follow-up phase groups (EG002, EG003) left out.", "decided_by": "both_coders" }, { "nct": "NCT02424188", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation (with weight management) in serious mental illness.", "note": "Integrated programme with varenicline or bupropion plus nicotine replacement vs referral to a quit line; no one randomized to bupropion and no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02431806", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Adolescent major depressive disorder.", "note": "Levomilnacipran 40 and 80 mg and the fluoxetine active control pooled against placebo.", "decided_by": "both_coders" }, { "nct": "NCT02434523", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic laryngitis / laryngeal neuropathy.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02458690", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in older adults with cardiovascular disease risk.", "note": "Collaborative stepped care (CBT and/or antidepressants by preference) vs usual care; no one randomized to an antidepressant and no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02466958", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "levomilnacipran" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Geriatric major depressive disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02477618", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "brexanolone" ], "background": "standard care for super-refractory status epilepticus", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Super-refractory status epilepticus.", "note": "SAGE-547 is brexanolone. The SAGE-547 group's description also mentions an open-label period for blinded non-responders; the safety set is defined by blinded infusion, so taken as the blinded arms, but whether open-label exposure is mixed into either group is unclear.", "decided_by": "both_coders" }, { "nct": "NCT02493868", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "esketamine" ], "background": "continued open-label oral antidepressant (duloxetine, escitalopram, sertraline or venlafaxine XR)", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Treatment-resistant depression (relapse prevention).", "note": "Maintenance phase: esketamine-stabilized participants randomized to continue esketamine (EG002) or switch to placebo (EG003). Induction, optimization and follow-up groups left out, as are EG006/EG007 (transferred-entry participants already on placebo from earlier studies). EG003's description says 'transferred-entry participants', which may be a labelling error.", "decided_by": "both_coders" }, { "nct": "NCT02501265", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Nicotine dependence (smoking cessation).", "note": "Standard vs adaptive pharmacotherapy within self-chosen varenicline or patch: bupropion was added only for pre-quit non-responders in the adaptive arms (others got placebo bupropion), and the arms also differ in pre-quit active varenicline/patch. Adverse events reported only as totals.", "decided_by": "both_coders" }, { "nct": "NCT02504931", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "COPE therapy (prolonged-exposure-based CBT for PTSD and alcohol use)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD with alcohol use disorder (both psychiatric).", "note": "Sertraline arm's text is cut off where it names its psychotherapy; read as the same COPE therapy the placebo arm gets.", "decided_by": "both_coders" }, { "nct": "NCT02516332", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Anxiety in patients with cardiovascular disease.", "note": "Supervised aerobic exercise group (EG000) left out.", "decided_by": "both_coders" }, { "nct": "NCT02520726", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "usual burn care", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Prevention of PTSD in burn patients.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02528409", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge eating disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02535000", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "elective spine surgery with usual perioperative care", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Postoperative pain after elective spine surgery.", "note": "Two perioperative doses; adverse events assessed over the first two postoperative days.", "decided_by": "both_coders" }, { "nct": "NCT02552225", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic laryngitis.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02579343", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in young adults.", "note": "Escitalopram in both arms with active vs sham auricular acupuncture; the trial tests acupuncture.", "decided_by": "both_coders" }, { "nct": "NCT02593396", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "methadone maintenance therapy", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Sexual dysfunction in men on methadone maintenance (codebook places sexual dysfunction under non-psychiatric).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02614547", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "brexanolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Severe postpartum depression.", "note": "SAGE-547 is brexanolone.", "decided_by": "both_coders" }, { "nct": "NCT02620150", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "CCBT (cognitive behavioral therapy)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in people with HIV/AIDS.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02623205", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression.", "note": "Placebo non-responders were offered 8-12 weeks of open-label SSRI after the placebo phase; the record doesn't say whether that period's events are in the placebo group, taken as the randomized placebo arm.", "decided_by": "both_coders" }, { "nct": "NCT02637895", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Post-traumatic stress disorder.", "note": "Only treatment-related adverse events at a 5% threshold reported.", "decided_by": "both_coders" }, { "nct": "NCT02638129", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Overweight/obesity with cardiovascular disease (cardiovascular outcomes).", "note": "Naltrexone/bupropion ER combination tablets. Randomized after a 2-week blinded tolerability lead-in (1 week combination, 1 week placebo, order randomized); lead-in has no adverse-event groups. Only serious, discontinuation-causing and special-interest adverse events collected.", "decided_by": "both_coders" }, { "nct": "NCT02646449", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Comorbid major depressive disorder and alcohol use disorder in young adults; both targeted, depression given as main.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02655354", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD prevention after injury; also depression, alcohol problems and disability targeted.", "note": "Stepped collaborative care with optional psychotropics (several antidepressants, prazosin, diphenhydramine) vs enhanced usual care; no one randomized to an antidepressant and no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02674529", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "real-time fMRI neurofeedback task before and after treatment", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02676375", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people with schizophrenia.", "note": "Open-label standard monotherapy (one cessation medication) vs extended bupropion plus nicotine replacement (with or without home visits); no placebo, and bupropion comes with other active drugs. Non-serious adverse events recorded non-systematically.", "decided_by": "both_coders" }, { "nct": "NCT02687165", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic pain in post-treatment Lyme syndrome.", "note": "Milnacipran in both arms with D-cycloserine or placebo added in weeks 6-12; the trial tests D-cycloserine. Adverse events were not monitored.", "decided_by": "both_coders" }, { "nct": "NCT02709655", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002", "EG003", "EG004" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine", "fluoxetine" ], "background": "brief psychosocial intervention sessions", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Paediatric major depressive disorder (ages 7-11).", "note": "Double-blind phase B groups; single-blind placebo lead-in group (EG000) left out. Fluoxetine active reference pooled with vortioxetine.", "decided_by": "both_coders" }, { "nct": "NCT02709746", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG004" ], "molecules": [ "vortioxetine", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Adolescent major depressive disorder (ages 12-17).", "note": "Double-blind groups; single-blind placebo lead-in group not randomized (EG000) left out. EG003 is titled fluoxetine 20 mg though its description repeats vortioxetine text.", "decided_by": "both_coders" }, { "nct": "NCT02720198", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with inadequate response to SSRIs.", "note": "Switch to levomilnacipran vs adding quetiapine to the current SSRI; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02736474", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Weight loss and smoking cessation in obese smokers with schizophrenia; both targeted, weight loss listed first.", "note": "Separate naltrexone tablets and bupropion capsules vs matching placebos for both; naltrexone is not part of one product with bupropion here.", "decided_by": "both_coders" }, { "nct": "NCT02737930", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Visual recovery after ischemic stroke.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02813447", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "intensive pulmonary rehabilitation", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression in COPD/interstitial lung disease (depression with a medical illness); anxiety and stress also listed.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02917122", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in Parkinson's disease.", "note": "Sertraline in both arms with active vs sham tDCS; the trial tests tDCS. Open-label, no placebo pill.", "decided_by": "both_coders" }, { "nct": "NCT02918318", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001", "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "esketamine" ], "background": "oral antidepressant", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression (Japan).", "note": "Double-blind induction groups only (esketamine 28/56/84 mg pooled). Follow-up, post-treatment (oral antidepressant only) and open-label groups (EG004-EG013) left out. One participant randomized to 84 mg is summarized under 56 mg.", "decided_by": "both_coders" }, { "nct": "NCT02929667", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Epilepsy (ventilatory response to CO2, SUDEP risk).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT02932904", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vortioxetine", "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Healthy volunteers; effect on sexual functioning.", "note": "Paroxetine active control pooled with vortioxetine 10 and 20 mg against placebo.", "decided_by": "both_coders" }, { "nct": "NCT02942004", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "brexanolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Severe postpartum depression.", "note": "SAGE-547 is brexanolone; 60 and 90 ug/kg/h pooled.", "decided_by": "both_coders" }, { "nct": "NCT02942017", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "brexanolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Moderate postpartum depression.", "note": "SAGE-547 is brexanolone.", "decided_by": "both_coders" }, { "nct": "NCT02960763", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant late-life depression.", "note": "Aripiprazole, bupropion or lithium augmentation vs switch to bupropion or nortriptyline; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02977299", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant major depressive disorder.", "note": "Aripiprazole augmentation vs rTMS augmentation vs switch to venlafaxine/duloxetine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT02978326", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "zuranolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Severe postpartum depression.", "note": "SAGE-217 is zuranolone. Part B (30 mg capsules vs placebo) only; Part A (EG000) has no placebo group of its own in the adverse-event table.", "decided_by": "both_coders" }, { "nct": "NCT02978781", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "zuranolone" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "non_psychiatric", "indication_note": "Essential tremor.", "note": "SAGE-217 is zuranolone. Part B: Part A responders randomized to continue SAGE-217 or switch to placebo. Open-label Parts A and C left out.", "decided_by": "both_coders" }, { "nct": "NCT02995915", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Concurrent smoking cessation and alcohol abstinence.", "note": "Both arms get the same tele-health CBT and smoking-cessation pharmacotherapy (nicotine replacement and bupropion); the trial tests mobile contingency management. Open-label, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03000530", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "zuranolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Moderate to severe major depressive disorder.", "note": "SAGE-217 is zuranolone. Part B double-blind groups only; open-label Part A (EG000) left out. Adverse events include a post-treatment period.", "decided_by": "both_coders" }, { "nct": "NCT03002012", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "standard-of-care fluconazole", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Cryptococcal antigenemia / cryptococcosis in people with HIV.", "note": "Sertraline 400 mg/day as an antifungal adjunct.", "decided_by": "both_coders" }, { "nct": "NCT03024606", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in pregnant women.", "note": "Text messages vs none on top of usual care with nicotine patch or bupropion; no one randomized to bupropion and no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03033069", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "sertraline" ], "background": "none (double-dummy placebos)", "combination": null }, { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "brexpiprazole", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Post-traumatic stress disorder.", "note": "2x2 factorial: sertraline vs placebo, and brexpiprazole plus sertraline vs brexpiprazole plus sertraline placebo.", "decided_by": "both_coders" }, { "nct": "NCT03038867", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Effect of duloxetine on male fertility; 'depression' is listed as a condition but the trial studies fertility.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03039192", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "esketamine" ], "background": "comprehensive standard of care including an standard-of-care oral antidepressant started or optimized on Day 1", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with imminent suicide risk.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03045341", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "none", "combination": "naltrexone" }, { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "behavioral weight loss counselling", "combination": "naltrexone" } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge-eating disorder with obesity; both targeted, binge eating given as main.", "note": "2x2 factorial of naltrexone/bupropion (combination medication) vs placebo, with or without behavioral weight loss. Non-serious adverse events only those listed on the Contrave label, at month 1.", "decided_by": "both_coders" }, { "nct": "NCT03047005", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": "naltrexone" } ], "design": "other", "indication": "other_psychiatric", "indication_note": "Binge-eating disorder with obesity (maintenance stage); both targeted, binge eating given as main.", "note": "Design 'other': a maintenance-stage randomization to 16 weeks of naltrexone/bupropion or placebo after an earlier treatment stage that the record does not describe, so not clearly acute or randomized withdrawal.", "decided_by": "both_coders" }, { "nct": "NCT03063606", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Binge-eating disorder with obesity (specialist-treatment stage).", "note": "This stage randomized CBT vs no CBT; the adverse-event groups are the blinded naltrexone/bupropion or placebo carried over from the acute stage, in a subset selected after that stage, not this trial's randomized arms.", "decided_by": "both_coders" }, { "nct": "NCT03090152", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Pain after total hip replacement for hip osteoarthritis.", "note": "Duloxetine is part of the multimodal regimen in every arm; the trial compares periarticular injection, epidural PCA, and both.", "decided_by": "both_coders" }, { "nct": "NCT03097133", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "esketamine" ], "background": "comprehensive standard of care including an standard-of-care oral antidepressant started or optimized on Day 1", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with imminent suicide risk.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03126682", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "", "note": "Both groups get bupropion SR 300 mg, differing only in which ECT session it accompanies (a timing/order comparison, crossover-like); no placebo group.", "decided_by": "both_coders" }, { "nct": "NCT03128021", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Late-life major depression.", "note": "Placebo was randomized only until 5/16/18; afterwards randomization was escitalopram vs levomilnacipran, so levomilnacipran (EG001) never had a randomized placebo and is left out. EG000 also holds people randomized after placebo ended. EG003 is open-label escitalopram for placebo non-responders (Phase II), left out.", "decided_by": "both_coders" }, { "nct": "NCT03132571", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Weight loss in people with schizophrenia (and type 2 diabetes/obesity); weight is the target.", "note": "Both arms take bupropion ER; the trial tests naltrexone (separate capsule) vs placebo.", "decided_by": "both_coders" }, { "nct": "NCT03169244", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge drinking / alcohol abuse (substance use).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03180294", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Low sexual desire (sexual dysfunction) in women with breast or gynecologic cancer.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03185819", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Paediatric MDD at imminent risk for suicide.", "note": "The comparator gets oral midazolam (a benzodiazepine 'psychoactive placebo') plus intranasal placebo, so it is an active comparator, not placebo. All arms also get standard care incl. an oral antidepressant. FU-phase groups (EG004-EG007) are post-treatment with no study drug.", "decided_by": "both_coders" }, { "nct": "NCT03226522", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "dextromethorphan-bupropion", "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Agitation in Alzheimer's dementia (behavioural symptoms of a neurocognitive disorder).", "note": "AXS-05 is dextromethorphan-bupropion (the record doesn't spell it out; its bupropion arm is the component comparator). Both antidepressant groups pooled against placebo.", "decided_by": "both_coders" }, { "nct": "NCT03249558", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "extended-release morphine up to 60 mg/day", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic low back or neck pain.", "note": "EG002 (duloxetine + placebo morphine) has no double-placebo counterpart and is left out.", "decided_by": "both_coders" }, { "nct": "NCT03271151", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "standard perioperative anaesthesia and analgesia for knee arthroplasty", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Postoperative pain and opioid use after total knee arthroplasty.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03272711", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine" ], "background": "online cognitive training", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Age-related cognitive decline in older adults; DSM-5 lists it as a condition that may be a focus of clinical attention, not a mental disorder.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03279471", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Anxiety in children with autism spectrum disorder.", "note": "EG000 (CBT/BIACA, no pill) left out.", "decided_by": "both_coders" }, { "nct": "NCT03315793", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Paediatric depressive disorder.", "note": "Duloxetine group includes a 1-week taper; placebo given for 7 weeks.", "decided_by": "both_coders" }, { "nct": "NCT03321006", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life depression with age-related hearing loss.", "note": "Both arms get escitalopram or duloxetine; the trial tests active vs sham hearing aids.", "decided_by": "both_coders" }, { "nct": "NCT03321526", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Both arms continue their SSRI/SNRI; the randomized contrast is seltorexant vs quetiapine XR, with no placebo arm. Follow-up groups are post-treatment.", "decided_by": "both_coders" }, { "nct": "NCT03328832", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Blood loss in total knee arthroplasty for knee osteoarthritis.", "note": "Topical tranexamic acid with or without Floseal, plus rivaroxaban in both; no antidepressant and no placebo (active-vs-active hemostatic comparison).", "decided_by": "both_coders" }, { "nct": "NCT03342027", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "Positively Smoke Free behavioral treatment", "combination": null }, { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "brief advice to quit (standard of care)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people living with HIV.", "note": "2x2 factorial (bupropion/placebo x behavioral treatment); one comparison per behavioral background.", "decided_by": "both_coders" }, { "nct": "NCT03374956", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Obesity.", "note": "Both arms get anti-obesity drugs (phentermine-topiramate, liraglutide, naltrexone/bupropion or phentermine), phenotype-guided vs randomly assigned; no placebo, and each group mixes drugs.", "decided_by": "both_coders" }, { "nct": "NCT03388164", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Both arms take escitalopram 10 mg; the trial tests RT2CK17 vs placebo in the same capsule.", "decided_by": "both_coders" }, { "nct": "NCT03429075", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram (with 1 mg psilocybin) is compared with psilocybin 25 mg plus placebo tablets, a psychedelic active comparator; no placebo-only group.", "decided_by": "both_coders" }, { "nct": "NCT03431831", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Obesity, with food-addiction status as a stratifier.", "note": "Contrave (naltrexone-bupropion) arms are compared with diet/activity usual care or counselling with no placebo described, despite 'double' masking; groups are also split by food-addiction status (FA-/FA+), which wasn't randomized.", "decided_by": "both_coders" }, { "nct": "NCT03434041", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "esketamine" ], "background": "newly started open-label oral antidepressant (duloxetine, escitalopram, sertraline or venlafaxine XR)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression.", "note": "Follow-up groups (EG002, EG003) get no intranasal drug and are left out. The placebo arm is labelled active comparator only because of the oral antidepressant both arms take.", "decided_by": "both_coders" }, { "nct": "NCT03464383", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Anxiety and depression in epilepsy; depression taken as main, anxiety a co-target.", "note": "Escitalopram started by the epileptologist (venlafaxine XR if not tolerated) vs psychiatry referral (usual care); the survey arm isn't randomized.", "decided_by": "both_coders" }, { "nct": "NCT03466346", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Depression with PTSD in Kenya; depression taken as main.", "note": "SMART design: IPT vs fluoxetine, then second-stage switches or combination for non-remitters; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03471767", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking / nicotine dependence.", "note": "AXS-05 (dextromethorphan-bupropion) vs bupropion SR: both antidepressants, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03527043", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Sperm DNA fragmentation / male infertility.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03534063", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Postoperative pain after arthroplasty.", "note": "CYP2D6 genotype-guided opioid prescribing vs usual care; antidepressants are mentioned only as CYP2D6 inhibitors and none is randomized.", "decided_by": "both_coders" }, { "nct": "NCT03534284", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "trazodone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Insomnia in patients on hemodialysis.", "note": "EG000 (CBT-I) left out.", "decided_by": "both_coders" }, { "nct": "NCT03538691", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "", "note": "All phases give brexpiprazole with antidepressant therapy (ADT); Phase C randomizes stabilized participants to continue brexpiprazole or switch to placebo, ADT continuing in both. Phase A/B groups are pre-randomization.", "decided_by": "both_coders" }, { "nct": "NCT03539900", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": "naltrexone" } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge-eating disorder.", "note": "Naltrexone-bupropion combination product (NB, Contrave).", "decided_by": "both_coders" }, { "nct": "NCT03548454", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic pain.", "note": "Open-label pragmatic duloxetine vs desipramine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03569475", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran", "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder in children and adolescents (7 to 17 years).", "note": "8-week double-blind treatment-period groups used; fluoxetine is an antidepressant comparator, pooled. The down-taper groups (EG003-EG005) are the same participants in the blinded 1-week taper, reported separately; left out so no one is counted twice, so taper-week events aren't counted.", "decided_by": "third_reader" }, { "nct": "NCT03574792", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Pain during chemoradiation for head and neck cancer.", "note": "Open-label gabapentin/methadone/oxycodone with or without venlafaxine; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03575403", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "methylphenidate and laboratory alcohol doses", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol use disorder (human laboratory study).", "note": "Per the AE group descriptions every arm got alcohol and methylphenidate, so groups differ only in duloxetine. EG001 (30 mg) had 2 participants; the arm was dropped in 2020 and the record says its data aren't reported, so it may hold no counts.", "decided_by": "both_coders" }, { "nct": "NCT03588572", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Subcortical aphasia after ischemic stroke (stroke recovery).", "note": "Control group gets no drug and no placebo (single-blind, no-intervention control).", "decided_by": "both_coders" }, { "nct": "NCT03591458", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Hypoglycemia unawareness in type 1 diabetes.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03595579", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "AXS-05 (dextromethorphan-bupropion; not spelled out here) vs bupropion: both antidepressants, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT03670316", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people with HIV.", "note": "Algorithm-guided cessation pharmacotherapy recommendation (e.g., varenicline) vs quitline referral; open-label, no placebo, and the algorithm group mixes drugs.", "decided_by": "both_coders" }, { "nct": "NCT03672175", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "zuranolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "SAGE-217 is zuranolone. Treatment-period groups used; follow-up (EG003-EG005) and extended follow-up (EG006-EG008) groups are the same participants after dosing ended, left out.", "decided_by": "both_coders" }, { "nct": "NCT03771664", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "zuranolone" ], "background": "none (both arms get single-blind placebo on days -2 to -1 and 15 to 21)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD with comorbid insomnia; depression is the main target.", "note": "SAGE-217 is zuranolone.", "decided_by": "both_coders" }, { "nct": "NCT03799198", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Obesity.", "note": "Open pragmatic trial: weight program plus one of five clinician-chosen weight-loss drugs (one is naltrexone/bupropion) vs program alone; no placebo, and the drug group mixes drugs.", "decided_by": "both_coders" }, { "nct": "NCT03812588", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "clinical-frequency management (monthly visits, phone calls every other week)", "combination": null }, { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "research-frequency management (weekly visits)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "2x2: visit frequency x escitalopram/placebo; one comparison per visit schedule. Responders continue blinded in a 3-month continuation phase.", "decided_by": "both_coders" }, { "nct": "NCT03826875", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Prevention of depression after aneurysmal subarachnoid hemorrhage.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03844412", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "nortriptyline" ], "background": "placebo cream (no active cream)", "combination": null }, { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "nortriptyline" ], "background": "lidocaine/estradiol vestibular cream", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Vestibulodynia (chronic vulvar pain); other pain conditions listed as comorbidities.", "note": "2x2 factorial of cream x nortriptyline; one comparison per cream.", "decided_by": "both_coders" }, { "nct": "NCT03854578", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "citalopram" ], "background": "none (BI 1358894-matching placebo in both)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD (single-dose fMRI mechanism study).", "note": "Single 20 mg citalopram dose vs placebo. Groups are as-treated: EG003 (got BI 1358894 and citalopram) mixes exposures and is left out, and per ae_note one patient randomized to BI 1358894 who got only placebo sits in EG000. EG002 (BI 1358894) isn't an antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT03897439", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Smoking cessation in African American smokers.", "note": "Open-label usual care (nicotine patch) vs optimized adaptive care (patch, then varenicline or bupropion plus patch); no placebo, and the optimized group mixes drugs.", "decided_by": "both_coders" }, { "nct": "NCT03924323", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Generalized anxiety disorder in children and adolescents.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT03946111", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none stated", "combination": "naltrexone" } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge-eating disorder with obesity.", "note": "Naltrexone-bupropion combination product. Title says participants were non-responders to earlier treatment (LDX/CBT), now randomized to NB or placebo; the record doesn't say whether earlier treatment continued.", "decided_by": "both_coders" }, { "nct": "NCT03950427", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in adults with serious mental illness.", "note": "Every arm gets bupropion and counseling; the trial tests active vs sedentary videogames.", "decided_by": "both_coders" }, { "nct": "NCT03978442", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD and cigarette smoking (both other psychiatric).", "note": "Both arms get bupropion, smoking-cessation CBT and CPT; the trial tests contingent vs yoked payments.", "decided_by": "both_coders" }, { "nct": "NCT03979820", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Healthy volunteers (tyramine pressor study).", "note": "Phenelzine is an open-label positive control given 7 days (then with tyramine); the placebo group is placebo for BI 1467335 over 28 days, so no group was randomized to placebo for phenelzine over the same period. EG000 is pre-randomization tyramine screening.", "decided_by": "both_coders" }, { "nct": "NCT03993457", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label escitalopram vs bupropion, assigned consistently or inconsistently with CRP level; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04019704", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dextromethorphan-bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "AXS-05 is bupropion and dextromethorphan (stated in the record).", "decided_by": "both_coders" }, { "nct": "NCT04094870", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Perinatal depression in women with HIV.", "note": "Open-label sertraline vs interpersonal therapy; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04103892", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "esketamine" ], "background": "ongoing standard antidepressant (Part A, 1 week)", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "esketamine" ], "background": "ongoing standard antidepressant (Part B, 4 weeks)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD, adjunctive treatment.", "note": "CLE-100 is oral esketamine, given as an adjunct to standard antidepressants (per title). Parts A and B differ in duration, so one comparison per part; the record doesn't say whether the parts enrolled different people.", "decided_by": "both_coders" }, { "nct": "NCT04124614", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD.", "note": "Both randomized arms take sertraline 150 mg; the trial tests brexpiprazole vs placebo. The 'Placebo' arm is everyone's 1-week run-in and has no AE group.", "decided_by": "both_coders" }, { "nct": "NCT04167306", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "none (varenicline placebo)", "combination": null }, { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol use disorder.", "note": "2x2 factorial varenicline x bupropion; one comparison per varenicline background.", "decided_by": "both_coders" }, { "nct": "NCT04174170", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD.", "note": "All randomized arms take sertraline 150 mg; the trial tests brexpiprazole 2 or 3 mg vs placebo. The 'Placebo' arm is the run-in.", "decided_by": "both_coders" }, { "nct": "NCT04178993", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "methylphenidate and laboratory methamphetamine/placebo doses", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine use disorder (human laboratory study).", "note": "Per the descriptions every arm got methylphenidate and acute methamphetamine/placebo, so the groups differ only in duloxetine 60 mg.", "decided_by": "both_coders" }, { "nct": "NCT04226365", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "nortriptyline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Post-concussive (post-traumatic) headache in adolescents and young adults.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04338321", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression.", "note": "Open-label esketamine vs quetiapine XR (antipsychotic), both added to continuing SSRI/SNRI; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04342663", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluvoxamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Symptomatic COVID-19.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04345471", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "MD-120 is desvenlafaxine (named in the interventions).", "decided_by": "both_coders" }, { "nct": "NCT04352101", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Bupropion vs escitalopram: both antidepressants, no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04395001", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic pain.", "note": "All arms take duloxetine; the trial tests web-based CBT and nurse support.", "decided_by": "both_coders" }, { "nct": "NCT04404439", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "nortriptyline", "paroxetine" ], "background": "none", "combination": "topiramate; verapamil" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Subjective tinnitus.", "note": "Each active arm looks like one compounded product (nortriptyline+topiramate; verapamil+paroxetine): one intervention per arm, both doses raised together at a fixed ratio to 8x, one matching placebo pill. Both pooled against the single placebo. If not judged one product, both groups drop out (combined_with_other_active).", "decided_by": "both_coders" }, { "nct": "NCT04436289", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Post-hospital care for people with and without HIV.", "note": "Behavioral home-visit intervention vs care as usual; no drug.", "decided_by": "both_coders" }, { "nct": "NCT04437485", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Depression with prediabetes (diabetes risk reduction).", "note": "Stepped collaborative care (CBT and/or algorithm-chosen antidepressants) vs usual-care active control; no placebo, and the intervention group mixes treatments.", "decided_by": "both_coders" }, { "nct": "NCT04442490", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "zuranolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "SAGE-217 is zuranolone.", "decided_by": "both_coders" }, { "nct": "NCT04442503", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "zuranolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Severe postpartum depression.", "note": "SAGE-217 is zuranolone.", "decided_by": "both_coders" }, { "nct": "NCT04468776", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic insomnia.", "note": "Zolpidem or trazodone (chosen by preference before randomization) vs internet CBT-I vs both; no placebo, and the CBT-I-alone group gets no pill.", "decided_by": "both_coders" }, { "nct": "NCT04476030", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "zuranolone" ], "background": "newly assigned oral antidepressant (sertraline, escitalopram, citalopram, duloxetine or desvenlafaxine) through day 42", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "SAGE-217 (zuranolone) or placebo on days 1-14, with the same assigned antidepressant in both arms.", "decided_by": "both_coders" }, { "nct": "NCT04510194", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluvoxamine" ], "background": "none (metformin placebo)", "combination": null }, { "antidepressant_groups": [ "EG004" ], "placebo_groups": [ "EG000" ], "molecules": [ "fluvoxamine" ], "background": "metformin", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Early outpatient COVID-19.", "note": "Factorial: metformin/placebo x ivermectin/fluvoxamine/placebo. Placebo-side groups (EG001, EG000) pool fluvoxamine-placebo and ivermectin-placebo recipients (shared controls), possibly including people randomized while the fluvoxamine arm wasn't open. Ivermectin groups (EG002, EG005) left out.", "decided_by": "both_coders" }, { "nct": "NCT04531176", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Obesity with type 2 diabetes.", "note": "Open pragmatic trial: weight program plus one of four clinician-chosen anti-obesity drugs (one is naltrexone/bupropion) vs program alone vs usual care; no placebo, and the drug group mixes drugs.", "decided_by": "both_coders" }, { "nct": "NCT04537806", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "brexanolone" ], "background": "mechanical ventilation and standard care for COVID-19 ARDS", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "ARDS due to COVID-19.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04597190", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "PTSD in primary care.", "note": "Sequenced strategies of SSRI, switch to venlafaxine and written exposure therapy; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04599478", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "none", "combination": "naltrexone" }, { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "behavioral weight loss counseling", "combination": "naltrexone" } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Loss-of-control eating after bariatric surgery (eating pathology); weight outcomes are a co-target.", "note": "2x2 factorial of naltrexone-bupropion (combination product) x behavioral weight loss; one comparison per behavioral background.", "decided_by": "both_coders" }, { "nct": "NCT04599855", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "esketamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression (esketamine monotherapy).", "note": "Open-label treatment/observation (EG003-EG006) and follow-up (EG007) groups left out.", "decided_by": "both_coders" }, { "nct": "NCT04605081", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "none", "combination": "naltrexone" } ], "design": "other", "indication": "other_psychiatric", "indication_note": "Loss-of-control eating after bariatric surgery; weight outcomes are a co-target.", "note": "Stage 2a 'maintenance' of a staged program whose acute stage randomized NB, placebo and behavioral weight loss; the record doesn't say whether everyone had NB before this randomization, so it isn't clearly acute or randomized withdrawal.", "decided_by": "both_coders" }, { "nct": "NCT04668950", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluvoxamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Early COVID-19.", "note": "", "decided_by": "both_coders" }, { "nct": "NCT04760652", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Depression with suicidal ideation after esketamine treatment.", "note": "Randomizes CBT vs treatment as usual after esketamine; no antidepressant or placebo is randomized.", "decided_by": "both_coders" }, { "nct": "NCT04798664", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Usual care, coverage of cessation drugs prescribed outside the study, financial incentives and an app; no randomized antidepressant or placebo.", "decided_by": "both_coders" }, { "nct": "NCT04850222", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Prevention of mental-health decline (presumably depressive symptoms) after musculoskeletal trauma; the record doesn't name the disorder.", "note": "Fluoxetine 10 mg vs calcium 1000 mg (an active comparator), single-blind; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04876521", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Post-schizophrenic depression.", "note": "Olanzapine-fluoxetine (combination product) vs low-dose amisulpride (antipsychotic); no placebo.", "decided_by": "both_coders" }, { "nct": "NCT04885530", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Outpatient COVID-19 (platform trial).", "note": "Each AE group is one appendix arm described as 'drug or placebo', so it pools the drug with its matched placebo; there is no separate placebo group. ae_note says arm-specific AE data are reported under each arm's own NCT ID (fluvoxamine Arms B and E appear as separate records in this batch).", "decided_by": "both_coders" }, { "nct": "NCT05014919", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Paediatric MDD (7-11 years), relapse prevention.", "note": "Open-label lead-in (EG000) left out.", "decided_by": "both_coders" }, { "nct": "NCT05047952", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Cognitive deficits in post-COVID-19 condition (could be read as a neurocognitive disorder, but the target is the post-infectious condition).", "note": "", "decided_by": "both_coders" }, { "nct": "NCT05071612", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002", "EG003" ], "placebo_groups": [ "EG004" ], "molecules": [ "trazodone" ], "background": "atomoxetine 75 mg", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Obstructive sleep apnea: DSM-5 counts it among sleep-wake (breathing-related sleep) disorders; clinically a medical condition, so non_psychiatric is the alternative reading.", "note": "AD504 = atomoxetine tablet + trazodone capsule; compared with atomoxetine 75 mg (EG004 appears to pool the atomoxetine and atomoxetine + placebo-capsule arms), so groups differ only in trazodone. AD109 groups (atomoxetine/aroxybutynin) and placebo EG005 left out.", "decided_by": "both_coders" }, { "nct": "NCT05277207", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Tobacco use in veterans.", "note": "Personalized counseling, pharmacotherapy and texting vs quitline/text referral; open-label, no placebo, and pharmacotherapy isn't a specified antidepressant.", "decided_by": "both_coders" }, { "nct": "NCT05289830", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Localized pancreatic or periampullary cancer; the record names no psychiatric target.", "note": "Masking is listed as single, but the title says double-blind; placebo-controlled.", "decided_by": "both_coders" }, { "nct": "NCT05329779", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "brexanolone" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Perimenopausal depression (mechanistic study).", "note": "Clean comparison, but ae_note says adverse events are not posted (low enrollment), so there may be no counts to use.", "decided_by": "both_coders" }, { "nct": "NCT05464979", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Critically ill ICU patients needing intubation.", "note": "Esketamine is given only as an IV anaesthetic induction agent (excluded by the codebook), against midazolam/fentanyl induction; no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05557409", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "dextromethorphan-bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Agitation in Alzheimer's disease (behavioural symptoms of a neurocognitive disorder).", "note": "AXS-05 is dextromethorphan-bupropion (not spelled out in this record).", "decided_by": "both_coders" }, { "nct": "NCT05575128", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Perioperative depression and anxiety in older adults having cardiac procedures; depression taken as main.", "note": "Behavioral activation plus medication review/optimization vs usual care; no antidepressant randomized and no placebo.", "decided_by": "both_coders" }, { "nct": "NCT05579249", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Obesity.", "note": "Open pragmatic: semaglutide vs one of four clinician-chosen anti-obesity drugs (one is naltrexone/bupropion); no placebo, and that group mixes drugs.", "decided_by": "both_coders" }, { "nct": "NCT05658874", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Chronic pelvic pain / interstitial cystitis-bladder pain syndrome.", "note": "Open multimodal bundle (amitriptyline or gabapentin among many treatments) vs usual urogynecologic care; no placebo, mixed exposures.", "decided_by": "both_coders" }, { "nct": "NCT05685511", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Perioperative depression and anxiety in older adults having oncologic surgery; depression taken as main.", "note": "Behavioral activation plus medication optimization vs usual-care resources; no antidepressant randomized.", "decided_by": "both_coders" }, { "nct": "NCT05697835", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Perioperative depression and anxiety in older adults having orthopedic surgery; depression taken as main.", "note": "Behavioral activation plus medication optimization vs usual care; no antidepressant randomized.", "decided_by": "both_coders" }, { "nct": "NCT05874037", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluvoxamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Long COVID.", "note": "The placebo arm's intervention is mislabelled 'Fluvoxamine' in the registry but is described as matched placebo. The open-label period after randomization collected no data.", "decided_by": "both_coders" }, { "nct": "NCT05890586", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluvoxamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Outpatient COVID-19.", "note": "ACTIV-6 Arm B appendix record (fluvoxamine 50 mg twice daily).", "decided_by": "both_coders" }, { "nct": "NCT05894564", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluvoxamine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Outpatient COVID-19.", "note": "ACTIV-6 Arm E appendix record (fluvoxamine 100 mg twice daily).", "decided_by": "both_coders" }, { "nct": "NCT05976646", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "dextromethorphan-bupropion" ], "background": "buprenorphine/naloxone for opioid use disorder", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Opioid use disorder (drug-interaction study).", "note": "Auvelity is dextromethorphan-bupropion, which counts as the antidepressant itself.", "decided_by": "both_coders" }, { "nct": "NCT06001021", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Perinatal depression and anxiety in couples; depression taken as main.", "note": "The medication arm allows an SSRI (escitalopram/sertraline) and/or alprazolam (benzodiazepine), so EG000 may combine or mix in a benzodiazepine the placebo group (EG005) doesn't get, though its AE description lists only the SSRIs. Per ae_note, AEs weren't assessed in the placebo, CBCT or no-intervention groups, so no placebo AE data exist either way.", "decided_by": "both_coders" }, { "nct": "NCT06192589", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Healthy volunteers (cannabidiol liver enzymes and drug interactions).", "note": "Citalopram is given only as two single doses in the Part 2 interaction cohort, together with cannabidiol; no group gets placebo for citalopram (the Part 1 placebo controls cannabidiol over 28 days).", "decided_by": "both_coders" }, { "nct": "NCT06340958", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "esketamine" ], "background": "current standard antidepressant", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to standard antidepressants (adjunctive).", "note": "CLE-100 is oral esketamine, added to the participant's current antidepressant.", "decided_by": "both_coders" } ]