[ { "nct": "NCT00000378", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Melancholic depression in late life.", "note": "Sertraline vs nortriptyline head to head; no placebo group." }, { "nct": "NCT00006170", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "weight concerns psychosocial intervention", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "standard smoking cessation counseling", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation (tobacco use disorder).", "note": "2x2 factorial; titles WC/SS = weight concerns/standard counseling, B/P = bupropion/placebo." }, { "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; both listed; fluoxetine taken as targeting depression.", "note": "" }, { "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": "Sertraline arm switched week-8 non-responders to venlafaxine. Supportive-expressive psychotherapy group (EG001) left out." }, { "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": "Double-dummy placebo. St John's Wort group (EG001) left out: herbal, not on the list and not described as an antidepressant." }, { "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": "Child and adolescent anxiety disorders.", "note": "CBT (EG001) and sertraline+CBT (EG002) left out: the CBT arm got no pill placebo, so CBT vs combination is not placebo-controlled, and the combination differs from placebo by CBT." }, { "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": "Major depression with psychotic features.", "note": "Both arms got olanzapine; sertraline vs placebo added to it." }, { "nct": "NCT00057551", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Chronic depression.", "note": "Every arm gets antidepressant medication (switch or addition); the trial randomizes CBASP or supportive psychotherapy vs medication only; open label, no placebo." }, { "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": "" }, { "nct": "NCT00066937", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Temporomandibular disorder pain.", "note": "2x2: nortriptyline vs low-dose benztropine, each with CBT or disease management. Benztropine is an active drug (apparently an active placebo), not a placebo; if accepted as placebo, comparisons would be EG000 vs EG001 (CBT) and EG002 vs EG003 (disease management)." }, { "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 placebo. SAM-e group (EG000) left out: supplement, not described as an antidepressant." }, { "nct": "NCT00074802", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Social anxiety disorder.", "note": "Partial responders after open-label paroxetine (Phase 1) randomized to continued paroxetine with or without CBT; no placebo." }, { "nct": "NCT00074815", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Pediatric OCD.", "note": "SRI partial responders randomized at entry to SRI medication management with CBT, instructional CBT, or alone; SRI in every arm, no placebo." }, { "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 group descriptions say they report serious adverse events." }, { "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 group (EG001) left out." }, { "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 names a sertraline pill, but its description is placebo identical to sertraline." }, { "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 in Alzheimer's disease.", "note": "" }, { "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": "" }, { "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": "EG000 got pramipexole plus placebo, EG002 escitalopram plus pramipexole, so they differ only in escitalopram. Escitalopram-plus-placebo group (EG001) has no placebo counterpart without pramipexole; left out." }, { "nct": "NCT00086385", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in older smokers.", "note": "Every arm gets 12 weeks of bupropion plus NRT (brief treatment); arms differ in extended NRT or tailored counseling; open label, no placebo." }, { "nct": "NCT00086411", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in light smokers.", "note": "Double dummy: bupropion vs nicotine patch, each with one of two counseling types; no group gets placebo for both, so bupropion is only compared with active nicotine patch (arm 3 is labelled placebo comparator but gets the patch)." }, { "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 groups (EG000, EG003) left out: supplement, not described as an antidepressant. Weeks 12-24 continuation groups (EG004, EG005) and crossover SAMe+escitalopram (EG006) left out: later period, selected participants, mixed exposures." }, { "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, but the arm and AE group are placebo." }, { "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 recurrence of MDD.", "note": "34 weeks of duloxetine, then randomized to continue or switch to placebo. AE groups taken as the double-blind phase (a placebo group exists only after randomization); duloxetine split by dose." }, { "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": "Adolescent MDD.", "note": "" }, { "nct": "NCT00113295", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Refractory generalized anxiety disorder.", "note": "Non-remitters after open-label paroxetine CR randomized to quetiapine or placebo added to continued paroxetine; EG002 is the open-label phase." }, { "nct": "NCT00114127", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Social anxiety disorder.", "note": "Non-remitters after open-label duloxetine 60 mg randomized to 60 mg plus placebo or 120 mg: a dose comparison, both groups on duloxetine." }, { "nct": "NCT00116857", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in coronary heart disease; cardiovascular risk factors also targeted.", "note": "Both arms get sertraline 50 mg; the trial tests omega-3 vs corn oil placebo." }, { "nct": "NCT00118404", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Relapse prevention in recurrent depression after response to cognitive therapy.", "note": "Titles and descriptions disagree: EG000 is titled fluoxetine but described as pill placebo, EG002 the reverse; coded by title (the columns the counts were entered under), so check. All had acute-phase CT; responders were randomized to start fluoxetine or placebo (not a withdrawal). Continuation CT group (EG001) left out." }, { "nct": "NCT00118417", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Treatment-resistant panic disorder.", "note": "AE groups are by phase: Phase I open-label sertraline for everyone, and the Phase II and III groups each pool both randomized arms (all on an SSRI); no placebo-only group." }, { "nct": "NCT00118430", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with musculoskeletal pain; both targeted.", "note": "Stepped care (antidepressant, then pain self-management) vs usual care; open label, no placebo." }, { "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": "" }, { "nct": "NCT00127673", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD.", "note": "Sertraline vs CBT, randomized to choice or no choice of treatment; no placebo." }, { "nct": "NCT00129272", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "weekly CBT for smoking cessation", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in youth; the official title names depressed youth.", "note": "" }, { "nct": "NCT00129467", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in cancer patients in hospice.", "note": "Both arms get an SSRI (continued, or citalopram started); the trial tests methylphenidate vs placebo." }, { "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; both listed.", "note": "" }, { "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": "" }, { "nct": "NCT00136760", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "contingent reinforcement", "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; the target is tobacco use.", "note": "2x2 factorial." }, { "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 in young people; both listed.", "note": "" }, { "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 (relapse prevention).", "note": "Responders to 14 weeks of open-label escitalopram randomized to continue or switch to placebo; open-label Phase I group (EG000) left out." }, { "nct": "NCT00149825", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with insomnia.", "note": "Both arms get escitalopram; the trial tests CBT for insomnia vs a control therapy." }, { "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 non-epileptic seizures (conversion disorder); comorbid depression and PTSD also listed.", "note": "Two-week untreated baseline lead-in in both arms." }, { "nct": "NCT00166114", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with childhood abuse.", "note": "Escitalopram vs desipramine head to head; no placebo." }, { "nct": "NCT00166296", "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-induced depression in hepatitis C.", "note": "" }, { "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 group (EG000) left out. The arm intervention lists swap zolpidem and escitalopram; the arm descriptions and AE groups agree." }, { "nct": "NCT00177294", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Late-life depression.", "note": "Partial responders after 6 weeks of escitalopram randomized to escitalopram plus IPT or plus care management; no placebo." }, { "nct": "NCT00177671", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Maintenance treatment of late-life depression; dementia also listed (donepezil for cognition).", "note": "Remitters after open-label antidepressant treatment randomized to donepezil or placebo added to the same antidepressant." }, { "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 children and youth; depression also listed.", "note": "Placebo group described as receiving no study medication, read as placebo." }, { "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": "" }, { "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 arm used one of three antidepressants chosen per participant. ICI-only group (EG002) left out: no pill placebo." }, { "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 group (EG000) left out." }, { "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 in type 2 diabetes.", "note": "" }, { "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": "Improvers after open-label escitalopram randomized to continue or switch to placebo; open-label phase group (EG000) left out." }, { "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, then randomized ziprasidone or placebo added to sertraline; EG000 is the open-label phase." }, { "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 groups (EG000, EG001) left out. ae_note says the trial was terminated and its data became inaccessible, so the posted AE counts may be missing." }, { "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, but it is described as an inactive comparator." }, { "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": "" }, { "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": "" }, { "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": "" }, { "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": "" }, { "nct": "NCT00247624", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with insomnia.", "note": "Both arms get fluoxetine; the trial tests eszopiclone vs placebo." }, { "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; every arm had a 1-week placebo run-in." }, { "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 placebo." }, { "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; both listed.", "note": "" }, { "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 in opioid addiction.", "note": "" }, { "nct": "NCT00262223", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "Seeking Safety (CBT for PTSD and substance use)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Comorbid PTSD and alcohol use disorder.", "note": "" }, { "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": "Cognition (executive dysfunction) in Huntington's disease, a neurological target.", "note": "" }, { "nct": "NCT00282828", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Generalized social anxiety disorder.", "note": "Phase I sertraline non-responders randomized to sertraline plus clonazepam, a switch to venlafaxine, or sertraline plus placebo; every arm is on an antidepressant and the placebo only masks clonazepam." }, { "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": "Diabetic peripheral neuropathic pain.", "note": "" }, { "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; the aim is reducing HIV risk behaviour; HIV infection and drug abuse also named.", "note": "Official title mentions HIV counseling; the arms describe only bupropion or placebo." }, { "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 to start fluoxetine or placebo; not a withdrawal design." }, { "nct": "NCT00292370", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Refractory PTSD.", "note": "Refractory participants after open-label paroxetine randomized to quetiapine or placebo added to paroxetine; EG000 is the open-label phase." }, { "nct": "NCT00296517", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "not stated (prior SSRI non-responders)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Depression not responding to SSRIs.", "note": "Whether the prior SSRI continued is not described; the same on both sides either way." }, { "nct": "NCT00296647", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Tobacco dependence.", "note": "Open-label bupropion vs nicotine patch and lozenge combinations; no placebo." }, { "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": "Supervised exercise group (EG000) left out." }, { "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": "ae_note says the type of adverse event is not specified in the final report." }, { "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": "" }, { "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": "" }, { "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 infection also listed.", "note": "" }, { "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": "Depressed cocaine-dependent patients; both conditions listed.", "note": "" }, { "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 (no contingency management)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Adolescent nicotine dependence.", "note": "2x2 factorial." }, { "nct": "NCT00338962", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol dependence with comorbid depression or PTSD.", "note": "2x2: paroxetine vs desipramine crossed with naltrexone vs placebo; every arm gets an antidepressant and the placebo is for naltrexone." }, { "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 (EG000) and CBT plus fluoxetine (EG003) left out: the CBT arm got no pill placebo or supportive therapy, so that contrast is not placebo-controlled." }, { "nct": "NCT00340379", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depression with psychotic features.", "note": "Ziprasidone vs sertraline plus haloperidol; no placebo, and the sertraline arm also gets an antipsychotic." }, { "nct": "NCT00354029", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Postoperative pain after hemorrhoidectomy.", "note": "S(+)-ketamine (esketamine) given perioperatively i.v. at low dose as an anaesthetic/analgesic adjunct, which the codebook leaves out; if counted, EG000 vs EG001 (saline) would be the comparison." }, { "nct": "NCT00354432", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "venlafaxine" ], "background": "placebo powder (no soy)", "combination": null }, { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine" ], "background": "soy protein/isoflavone powder", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Hot flashes in men with prostate cancer.", "note": "2x2 factorial; the arm types are mislabelled but the group descriptions are clear." }, { "nct": "NCT00360399", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram vs duloxetine vs CBT; no placebo." }, { "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, depressive disorder NOS).", "note": "ae_note: non-serious AEs were assessed only in completers. Placebo arm's intervention list names duloxetine, but the arm is placebo." }, { "nct": "NCT00368550", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "coping skills (cognitive-behavioral) therapy", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol dependence.", "note": "" }, { "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) left out." }, { "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": "" }, { "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 pooled." }, { "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 is the active reference, pooled as an antidepressant; double-dummy placebo; includes a 1-week taper." }, { "nct": "NCT00385671", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Diabetic peripheral neuropathic pain.", "note": "Open-label duloxetine vs pregabalin vs duloxetine plus gabapentin; no placebo." }, { "nct": "NCT00386243", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic musculoskeletal pain in veterans.", "note": "Stepped care (analgesic and co-analgesic therapy, self-management, CBT) vs usual care, open label; no antidepressant named in the groups and no placebo." }, { "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 also targeted.", "note": "Three sequences over 8 weeks (placebo-placebo, placebo-escitalopram, escitalopram-placebo); each escitalopram group mixes 4 weeks of drug with 4 of placebo. If such groups were accepted, EG001 and EG002 vs EG000 differ only in escitalopram timing." }, { "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 group: after 15 weeks of open-label DVS 100 mg, re-randomized to 2-week tapers (EG005, EG006) or abrupt switch to placebo (EG008). EG007 (one week DVS then one week placebo) left out as mixed exposure; titration groups EG000-EG003 (all DVS) and open-label EG004 left out." }, { "nct": "NCT00401726", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label venlafaxine ER with or without the Dialogues patient program; no placebo." }, { "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": "Rescued-placebo group (EG002, events after switching to duloxetine) left out; both arms had a 1-week placebo lead-in and a 12-week continuation." }, { "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": "" }, { "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": "Diabetic peripheral neuropathic pain.", "note": "" }, { "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; obesity also listed.", "note": "" }, { "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; escitalopram is the active reference. Discontinuation-phase groups (EG003-EG005) left out: post-treatment period of the same participants." }, { "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) left out: investigational, and the record gives no class or calls it an antidepressant; if counted it would join paroxetine against placebo." }, { "nct": "NCT00422162", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Severe MDD in hospitalized patients.", "note": "Duloxetine 60 vs 120 mg; placebo only masks the dose." }, { "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 head to head; no placebo." }, { "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": "" }, { "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": "Selegiline transdermal system (transdermal selegiline, an MAOI listed in the codebook) vs matching placebo patch for smoking cessation." }, { "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 gets free NRT or bupropion; no placebo." }, { "nct": "NCT00445679", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Desvenlafaxine 50/100/200 mg vs paroxetine 20 mg; both antidepressants but no placebo arm." }, { "nct": "NCT00449007", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with comorbid alcohol abuse/dependence; depression is the main target.", "note": "Fluoxetine vs bupropion head to head; no placebo." }, { "nct": "NCT00452543", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with comorbid alcohol abuse/dependence.", "note": "Escitalopram in both arms; the randomized drug is acamprosate vs placebo." }, { "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 (NB32) combination product vs placebo in obesity." }, { "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": "", "note": "Duloxetine vs placebo for central pain in multiple sclerosis." }, { "nct": "NCT00465972", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Insomnia in HIV-positive patients.", "note": "A doxepin arm was randomized, but the AE tables report only Placebo and Temazepam groups." }, { "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": "", "note": "Topical cream holding amitriptyline 4% and ketamine 2% in one product vs placebo cream; ketamine marked as the combination drug." }, { "nct": "NCT00474630", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "ancillary (lifestyle) therapy", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Obesity with type 2 diabetes.", "note": "Naltrexone SR/bupropion SR (NB32) combination product vs placebo." }, { "nct": "NCT00474708", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label venlafaxine XR vs SSRI or conventional antidepressant after switching; no placebo." }, { "nct": "NCT00475878", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "office-based buprenorphine treatment for opioid dependence", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Conditions list opiate dependence and depression; read as depression in patients entering buprenorphine treatment (antidepressant trial), with opioid dependence the setting.", "note": "Escitalopram 10 mg vs placebo, both sides entering buprenorphine treatment." }, { "nct": "NCT00475904", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "amitriptyline" ], "background": "none", "combination": "ketamine" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "NP-1 cream holds amitriptyline 4% and ketamine 2% in one product; both sides also take placebo capsules (double dummy). Gabapentin group EG001 is an active comparator and left out." }, { "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": "", "note": "NP-1 cream (amitriptyline 4%/ketamine 2%, one product) vs vehicle cream for diabetic neuropathy pain." }, { "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": "", "note": "Citalopram vs placebo in irritable bowel syndrome." }, { "nct": "NCT00482612", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia.", "note": "Esmirtazapine (Org 50081), the S-enantiomer of mirtazapine, is not on the codebook's list (which names enantiomers separately) and the record does not describe it as an antidepressant. If it counted as mirtazapine, the comparison would be in-treatment groups EG000-EG002 vs EG003; the follow-up groups EG004-EG007 are off-drug periods." }, { "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 in MSM with high-risk HIV behaviours.", "note": "Mirtazapine 30 mg vs placebo." }, { "nct": "NCT00506389", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia.", "note": "Esmirtazapine (Org 50081, S-enantiomer of mirtazapine) is not on the codebook's list and the record does not call it an antidepressant. If counted, in-treatment groups EG000-EG001 vs EG002; follow-up groups EG003-EG005 are off-drug." }, { "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 is a non-antidepressant active arm and left out." }, { "nct": "NCT00511134", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Insomnia during smoking cessation (nicotine dependence).", "note": "Bupropion SR (Zyban) in both arms; the randomized drug is eszopiclone vs placebo." }, { "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": "One topical PLO gel holds baclofen, amitriptyline and ketamine (BAK) vs placebo gel; baclofen and ketamine marked as the combination drugs." }, { "nct": "NCT00519428", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram + bupropion vs escitalopram vs bupropion; no placebo." }, { "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 teens; PMS (unlike PMDD, a DSM-5 depressive disorder) is not a DSM-5 mental disorder, though its mood symptoms overlap.", "note": "Luteal-phase escitalopram vs matched placebo." }, { "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 (selegiline transdermal system) vs placebo patch in adolescents with MDD." }, { "nct": "NCT00532779", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000", "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "ancillary (lifestyle) therapy", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "NB16 and NB32 (naltrexone SR/bupropion SR combination product) pooled vs placebo." }, { "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": "Borderline personality disorder (suicidal behaviour and self-injury).", "note": "2x2 factorial of psychotherapy (DBT vs supportive) and fluoxetine vs placebo; one comparison per psychotherapy." }, { "nct": "NCT00534001", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation (tobacco use disorder); cancer conditions listed are not the target.", "note": "Open-label comparison of 1-week vs 4-week pre-cessation bupropion: Arm I takes placebo weeks 1-3 then bupropion, so both AE groups receive bupropion and Arm I's group mixes exposures." }, { "nct": "NCT00535288", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms.", "note": "Esmirtazapine (Org 50081, S-enantiomer of mirtazapine) is not on the codebook's list and the record does not call it an antidepressant. If counted, EG001-EG004 vs EG000." }, { "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": "" }, { "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 (luteal) sertraline vs placebo." }, { "nct": "NCT00536471", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "The Placebo group (EG001) mixes exposures: placebo patients meeting rescue criteria in the first 3 months were switched to duloxetine 60 mg within the same 9-month group. If rescue switches were tolerated, the comparison would be EG000 vs EG001." }, { "nct": "NCT00539240", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "nortriptyline" ], "background": "rabeprazole 20 mg once daily", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "GERD not responding to standard-dose PPI.", "note": "EG000 and EG001 descriptions conflict (arm text vs intervention text swapped). EG001 ('Arm 2') taken as the rabeprazole once-daily + placebo dinner + placebo bedtime arm by title order and first line, matching the nortriptyline arm EG002; EG000 (rabeprazole twice daily + bedtime placebo) left out because its background differs. If the intervention text is right instead, the placebo group is EG000." }, { "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 (functional) dyspepsia.", "note": "" }, { "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": "Duloxetine 40 and 60 mg pooled vs placebo." }, { "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": "PTSD.", "note": "Single-blind placebo-controlled; the paroxetine group includes its taper phase." }, { "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": "Subthreshold PTSD (secondary prevention).", "note": "" }, { "nct": "NCT00560833", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Menopausal vasomotor symptoms.", "note": "Esmirtazapine (Org 50081, S-enantiomer of mirtazapine) is not on the codebook's list and the record does not call it an antidepressant. If counted, EG001-EG004 vs EG000." }, { "nct": "NCT00561574", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia in the elderly.", "note": "Esmirtazapine 1.5 vs 3.0 mg (not on the codebook's list); there is also no placebo group." }, { "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 (Org 50081) is not on the codebook's list and the record does not call it an antidepressant. If counted, EG000-EG002 vs EG003 (all groups include the same placebo run-in and run-out)." }, { "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": "Citalopram vs placebo added to baseline mood stabilizers, acute and continuation phases." }, { "nct": "NCT00564278", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Both arms get standard antidepressant therapy; the trial tests adding motivational interviewing. No placebo." }, { "nct": "NCT00567255", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "ancillary (lifestyle) therapy", "combination": "naltrexone" } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Naltrexone SR/bupropion SR combination product vs placebo. EG000 pools NB32 with NB48 (non-responders re-randomized at week 28 to a higher naltrexone dose, bupropion unchanged); still the randomized combination arm." }, { "nct": "NCT00572234", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Methamphetamine use disorder.", "note": "Open-label bupropion SR vs treatment as usual (no intervention); no placebo." }, { "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": "Mental stress-induced myocardial ischemia in coronary heart disease.", "note": "" }, { "nct": "NCT00578669", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "brief smoking cessation counseling and transdermal nicotine patch", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in smokers with elevated depressive symptoms; conditions also list MDD and depression, but the title targets smokers.", "note": "Fluoxetine vs placebo (dextrose) begun 8 weeks before and continued through cessation treatment." }, { "nct": "NCT00580645", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Alcohol drinking.", "note": "Varenicline vs placebo; no antidepressant." }, { "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 (laboratory model).", "note": "Varenicline group EG000 is a non-antidepressant active arm and left out; AEs cover a 1-week medication period." }, { "nct": "NCT00581009", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depressed patients with MDD or bipolar disorder.", "note": "Open-label chronotherapy augmentation vs medication only (SSRI plus lithium); no placebo. The augmentation group probably also takes the medication, but the record does not say." }, { "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 SR vs escitalopram + placebo differ only in bupropion. Venlafaxine XR + mirtazapine (EG001) has a different background and is left out. AE note says only serious AEs were recorded." }, { "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": "MDD or dysthymia after spinal cord injury.", "note": "" }, { "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": "Relapse prevention: open-label vortioxetine (EG000, everyone, left out), then responders randomized to vortioxetine 5/10 mg or placebo in the double-blind period." }, { "nct": "NCT00601965", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "randomized_withdrawal", "indication": "other_psychiatric", "indication_note": "Generalized anxiety disorder in older adults.", "note": "All arms take 12 weeks open-label then 16 weeks continuation escitalopram (with or without CBT) before 28 weeks of escitalopram vs placebo maintenance; each AE group's description spans the whole sequence, so the placebo groups mix escitalopram and placebo exposure. If AEs covered only the maintenance phase, the comparisons would be EG000 vs EG002 (CBT) and EG001 vs EG003 (no CBT)." }, { "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": "Citalopram + methylphenidate vs placebo + methylphenidate differ only in citalopram. Citalopram + placebo (EG000) has no matching placebo-only group (its comparator would be methylphenidate, an active drug) and is left out." }, { "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": "Interpersonal psychotherapy alone (EG002) is left out." }, { "nct": "NCT00602537", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Bipolar II major depression.", "note": "Venlafaxine vs lithium (a non-antidepressant active comparator); no placebo." }, { "nct": "NCT00603265", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Diabetic peripheral neuropathic pain.", "note": "EG001 and EG002 have their descriptions swapped relative to titles; groups taken by title and arm order (EG001 Duloxetine, EG002 Placebo). ADL5859 (EG000), an investigational non-antidepressant, is left out. Duloxetine group takes evening placebo capsules (double dummy)." }, { "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; binge eating taken as the main target, depression a co-target.", "note": "" }, { "nct": "NCT00611975", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Healthy women (effects on sex hormones and sexual function).", "note": "Fluoxetine vs bupropion; no placebo." }, { "nct": "NCT00612313", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Paediatric MDD.", "note": "All take fluoxetine; after 6 weeks of fluoxetine, participants are assigned to continued fluoxetine alone or with relapse-prevention CBT. Design is sequential (open-label drug, then randomized add-on psychotherapy)." }, { "nct": "NCT00612807", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life MDD with marital distress.", "note": "Both arms get antidepressant medication management; the trial tests adding marital therapy. No placebo." }, { "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": "Milnacipran 100-200 mg vs placebo; per the AE note each group spans the double-blind period and a single-blind placebo discontinuation period at the end (a taper off the randomized drug, kept with its arm)." }, { "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) is a non-antidepressant active arm; donepezil + duloxetine (EG002) adds a separate active drug and its donepezil dose (2.5 mg) differs from EG000 (5 mg), so it has no clean comparator. Both left out." }, { "nct": "NCT00620776", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Generalized anxiety disorder.", "note": "Open-label venlafaxine XR in both arms; the trial tests adding CBT. No placebo." }, { "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 lists among sleep-wake disorders (often considered neurological).", "note": "" }, { "nct": "NCT00621777", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "randomized_withdrawal", "indication": "other_psychiatric", "indication_note": "Smoking relapse prevention in schizophrenia, schizoaffective or bipolar disorder.", "note": "Open-label varenicline then varenicline vs placebo relapse prevention; no antidepressant." }, { "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 with severe asthma.", "note": "" }, { "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 with diabetes (outcomes include A1c).", "note": "" }, { "nct": "NCT00625131", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in PTSD.", "note": "Bupropion SR and CBT in both arms; the randomized comparison is nicotine vs placebo patch." }, { "nct": "NCT00631657", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic primary insomnia.", "note": "Esmirtazapine (Org 50081, S-enantiomer of mirtazapine) is not on the codebook's list and the record does not call it an antidepressant. If counted, EG000 vs EG001." }, { "nct": "NCT00634283", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Healthy volunteers; conditions list depression but no one is treated for it.", "note": "Both groups receive venlafaxine in this study; they are defined by prior exposure in an earlier study (venlafaxine vs placebo only), so the 'naive' group is formerly-placebo participants now on the drug. No placebo comparison here." }, { "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": "Vortioxetine 2.5/5/10 mg and the duloxetine 60 mg reference arm pooled vs placebo." }, { "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 (a DSM-5 other specified feeding or eating disorder).", "note": "" }, { "nct": "NCT00641719", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Diabetic peripheral neuropathic pain.", "note": "Open-label long-term extension with duloxetine 40 vs 60 mg; no placebo." }, { "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 randomized drug is ramelteon vs placebo." }, { "nct": "NCT00643162", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life depression.", "note": "Escitalopram (Lexapro) in both arms; the trial tests Swedish massage vs light touch." }, { "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 recently abstinent patients with depressive symptoms; cocaine dependence taken as main (official title), depressive symptoms a co-target.", "note": "Sertraline + gabapentin (EG002) adds a separate active drug and is left out; sertraline alone took a gabapentin placebo." }, { "nct": "NCT00655057", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Depressed patients get escitalopram or CBT, plus a healthy imaging-only group; no placebo. AE note says the data are not available." }, { "nct": "NCT00666757", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Severe depressive episode.", "note": "Open-label duloxetine vs generic SSRIs; no placebo." }, { "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; cancer conditions listed are not the target.", "note": "" }, { "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": "Escitalopram low and high fixed doses pooled vs placebo." }, { "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": "Vortioxetine 2.5/5 mg and duloxetine 60 mg pooled vs placebo; each active group includes a 1-week discontinuation (placebo or duloxetine 30 mg taper) after the 8 weeks, matched by 9 weeks of placebo." }, { "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": "" }, { "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": "" }, { "nct": "NCT00677352", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Panic disorder.", "note": "Sertraline vs paroxetine head to head; no placebo." }, { "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": "" }, { "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": "One-year treatment." }, { "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": "" }, { "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 acute coronary syndrome.", "note": "" }, { "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 in women.", "note": "Stage 1 of an adaptive design (stopped after stage 1); pregabalin reference group (EG002) is a non-antidepressant active arm and left out." }, { "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": "Generalized anxiety disorder in older adults.", "note": "Sertraline 50 and 100 mg pooled vs placebo." }, { "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": "Delaying progression of Alzheimer's disease; the codebook counts only behavioural symptoms of neurocognitive disorders as psychiatric, not disease progression.", "note": "" }, { "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": "" }, { "nct": "NCT00711477", "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": "Obesity (fMRI study).", "note": "Naltrexone SR/bupropion SR (NB32) combination product vs placebo; both sides have fMRI scans." }, { "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": "Generalized anxiety disorder.", "note": "Vortioxetine 2.5/5/10 mg and duloxetine 60 mg reference pooled vs placebo; active groups include a 1-week discontinuation after 8 weeks, matched by 9 weeks of placebo." }, { "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": "Generalized anxiety disorder.", "note": "" }, { "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": "28-day escitalopram vs placebo." }, { "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": "Generalized anxiety disorder.", "note": "" }, { "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 in spinal cord injury.", "note": "Placebo follows the same titration and taper schedule." }, { "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": "Vortioxetine 1/5/10 mg pooled vs placebo." }, { "nct": "NCT00742573", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Antidepressants by the Texas Medication Algorithm vs patient choice of brief IPT alone or with the same medication; no placebo." }, { "nct": "NCT00744328", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "sertraline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Postpartum depression.", "note": "Triple dummy: sertraline group wears a placebo patch, placebo group gets placebo patch and pills. Transdermal estradiol (EG000) is a non-antidepressant active arm and left out." }, { "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": "Generalized anxiety disorder.", "note": "" }, { "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": "Double-blind acute-phase groups only; the open-label extension group (EG002) is left out." }, { "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": "The placebo arm's description says 'No treatment' but it took matching nortriptyline-placebo capsules on the same schedule." }, { "nct": "NCT00767624", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with insomnia.", "note": "Both arms take algorithm-chosen antidepressants (sertraline, escitalopram or desvenlafaxine); the trial compares CBT for insomnia with desensitization therapy. No placebo." }, { "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": "" }, { "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": "Trazodone Contramid once-a-day (extended release) vs placebo." }, { "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 hot flashes.", "note": "Paroxetine mesylate 7.5 mg (Brisdelle) vs sugar pill." }, { "nct": "NCT00789854", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression.", "note": "Open-label: quetiapine XR monotherapy (SSRI/venlafaxine stopped), quetiapine XR add-on, or lithium add-on; the SSRI or venlafaxine was continued prior therapy, never randomized; no placebo." }, { "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": "Severe mood dysregulation (chronic irritability), the forerunner of DSM-5 disruptive mood dysregulation disorder, a depressive disorder; participants also have ADHD (other_psychiatric).", "note": "Open-label methylphenidate was optimized first; youth still irritable were then randomized to add citalopram or placebo." }, { "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." }, { "nct": "NCT00797966", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Brexpiprazole (OPC-34712) or placebo added to physician-assigned ADT in every arm, randomized after a prospective ADT phase." }, { "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": "", "note": "" }, { "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": "" }, { "nct": "NCT00806234", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Targets antipsychotic-related weight gain and metabolic problems in youth; the listed condition is psychotic disorders (other_psychiatric).", "note": "Randomized to continue the current antipsychotic, switch to aripiprazole or perphenazine, or add metformin; olanzapine/fluoxetine appears only as a possible continued antipsychotic; no antidepressant randomized, no placebo." }, { "nct": "NCT00807248", "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": "Escitalopram plus gaboxadol placebo vs double placebo. Escitalopram plus gaboxadol groups (EG002, EG003) left out: gaboxadol is another active drug and no group gets gaboxadol alone." }, { "nct": "NCT00810069", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "", "note": "Open-label escitalopram for 4 weeks (EG000), then non-improvers randomized double-blind to an early switch to duloxetine or continued escitalopram with a later switch; every group takes an antidepressant; no placebo. Design other: randomized switch strategy after a lead-in." }, { "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": "MDD in elderly patients.", "note": "Duloxetine 60 mg is an antidepressant reference arm, pooled with vortioxetine." }, { "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": "MDD in children and adolescents.", "note": "" }, { "nct": "NCT00818207", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Randomized to full or no reimbursement of smoking-cessation treatment of the participant's choice; no antidepressant randomized, no placebo." }, { "nct": "NCT00824044", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label escitalopram vs CBT; no placebo." }, { "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": "", "note": "Registry arm entries are garbled (the placebo arm lists DVS SR, the experimental arm genotyping); the AE groups are clearly DVS SR 50 mg and placebo." }, { "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 eszopiclone or placebo." }, { "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 placebo group's description repeats the bupropion dosing text, but it is titled Sugar Pill under the placebo-comparator arm." }, { "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 metformin or placebo." }, { "nct": "NCT00834834", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Borderline personality disorder with suicidal behaviour and self-injury.", "note": "Fluoxetine (or citalopram) with clinical management vs dialectical behavior therapy; no placebo." }, { "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": "", "note": "Venlafaxine XL 225 mg is an antidepressant reference arm, pooled with vortioxetine." }, { "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 youth.", "note": "Olanzapine/fluoxetine combination product vs placebo." }, { "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": "MDD in children and adolescents.", "note": "Acute groups only; extension groups (EG004 to EG007) left out: placebo participants switched to duloxetine." }, { "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": "MDD in children and adolescents.", "note": "Acute groups only; extension groups (EG003 to EG005) left out: placebo participants switched to duloxetine." }, { "nct": "NCT00854100", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Cariprazine or placebo added to ongoing ADT after an 8-week ADT lead-in (EG000)." }, { "nct": "NCT00857584", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Bipolar depression.", "note": "Open-label quetiapine XR vs sertraline, each added to lithium or valproate; no placebo." }, { "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": "", "note": "" }, { "nct": "NCT00866294", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003", "EG006" ], "placebo_groups": [ "EG000" ], "molecules": [ "paroxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "EG003 and EG006 are the whole paroxetine CR and IR arms (IR is an antidepressant reference); their starting-dose subgroups (EG001, EG002, EG004, EG005) are left out so no one is counted twice." }, { "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 intensive care.", "note": "" }, { "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": "", "note": "Open-label phases (EG000 to EG002) left out. Double-blind taper/follow-up groups (EG005, EG006) re-count the randomized participants in a later window and are left out." }, { "nct": "NCT00892047", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life depression with incomplete response.", "note": "Venlafaxine in both arms; aripiprazole vs placebo augmentation." }, { "nct": "NCT00894166", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "nicotine patch; pre-quit patch nonresponders", "combination": null }, { "antidepressant_groups": [ "EG004" ], "placebo_groups": [ "EG006" ], "molecules": [ "bupropion" ], "background": "nicotine patch; post-quit lapsers", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Two separate randomizations of patch nonresponders: add bupropion, switch to varenicline, or continue the patch. No bupropion placebo is named, but the trial is registered triple-masked, so continued patch is taken as no added drug in a double-blind design. NRT responders (EG000, not randomized) and varenicline groups (EG002, EG005) left out." }, { "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": "" }, { "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": "" }, { "nct": "NCT00905424", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "After an 8-week escitalopram lead-in, randomized to lisdexamfetamine (SPD489) or placebo added to escitalopram." }, { "nct": "NCT00909155", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Venlafaxine vs fluoxetine; the control group is non-depressed volunteers, not randomized and given no drug; no placebo." }, { "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." }, { "nct": "NCT00930293", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with panic and anxiety symptoms.", "note": "Open-label citalopram in both arms; compares IPT-PS with brief supportive psychotherapy." }, { "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": "" }, { "nct": "NCT00936299", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "CBT", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "ADHD in adolescents with nicotine dependence and cannabis use disorder.", "note": "" }, { "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": "Double-placebo group (EG002) left out: no bupropion-alone group to pair it with." }, { "nct": "NCT00945945", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Osteoarthritis knee pain.", "note": "A labeling error mixed both arms: DLX30-PLA took duloxetine 30 mg for 1 week then placebo for 12, PLA-DLX60 took placebo for 1 week then duloxetine 60 mg for 12; both groups mix exposures." }, { "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 depressive episode in chronic kidney disease.", "note": "" }, { "nct": "NCT00955474", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Major depression with psychotic features.", "note": "Quetiapine XR alone vs quetiapine XR plus an SSRI (sertraline, escitalopram or citalopram), single-blind with no placebo, so quetiapine alone is not a placebo group." }, { "nct": "NCT00958568", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Treatment-resistant depression, relapse prevention.", "note": "Stabilized on open-label OFC (EG000, EG001), then randomized to continue OFC or switch to fluoxetine alone: fluoxetine is in both arms and the trial tests olanzapine; no placebo." }, { "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 relapse); could be read as bipolar disorder outside a depressive episode (other_psychiatric).", "note": "Remitters on open-label escitalopram or bupropion XL plus mood stabilizer (EG002) were randomized to continue the antidepressant for 52 weeks or stop it at 8 weeks (blinded taper from week 6); the 8-week group took the antidepressant for its first 6 to 8 randomized weeks, so it mixes exposures." }, { "nct": "NCT00960986", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Four open-label duloxetine dosing strategies (starting dose, with or without food); no placebo." }, { "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, relapse and recurrence prevention.", "note": "Responders to open-label lithium plus fluoxetine (EG000) randomized to keep fluoxetine or switch to placebo; EG001 is empty (no one took placebo in Phase I). ae_note says all events were noted in Phase I, so the Phase II groups may hold none." }, { "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": "Children with both anxiety and recurrent abdominal pain; anxiety taken as the main target, abdominal pain (non_psychiatric) as the other.", "note": "" }, { "nct": "NCT00962988", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people with cerebrovascular disease.", "note": "Randomized to cost-free cessation medication or a prescription only; the drug is not specified or randomized; no placebo." }, { "nct": "NCT00964886", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG003" ], "molecules": [ "desipramine" ], "background": "none", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "desipramine" ], "background": "CBT", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Chronic back pain.", "note": "EG003 is an active placebo (benztropine 0.125 mg) that the record calls a placebo, taken as the placebo group. The CBT-alone arm names no pill, but the trial is triple-masked, so it is taken as no added drug in a double-blind design for desipramine plus CBT." }, { "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": "EG002 is a rescue group (participants with MDD whose depression worsened, moved to duloxetine 60 mg) and is left out." }, { "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": "Premenstrual syndrome, not PMDD (which would be depressive).", "note": "Calcium group (EG001) left out. ae_note: AE data available only for the 32 patients at one site." }, { "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": "", "note": "" }, { "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": "", "note": "" }, { "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": "" }, { "nct": "NCT00985504", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with residual apathy.", "note": "Switch to duloxetine vs escitalopram; no placebo." }, { "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 partial epilepsy.", "note": "ae_note says the PI left without entering results and no study data are available, so these groups may hold no data." }, { "nct": "NCT00991081", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Randomized to genetic feedback or not; both arms get counseling and genotype-assigned bupropion or nicotine patch, open-label; no placebo." }, { "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": "" }, { "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": "MDD with associated painful physical symptoms.", "note": "" }, { "nct": "NCT01014585", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "milnacipran" ], "background": "none (responder stratum)", "combination": null }, { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG002" ], "molecules": [ "milnacipran" ], "background": "none (non-responder stratum)", "combination": null } ], "design": "randomized_withdrawal", "indication": "non_psychiatric", "indication_note": "Fibromyalgia.", "note": "Patients on long-term milnacipran randomized, separately for responders and non-responders, to continue it or switch to placebo; kept as one comparison per stratum." }, { "nct": "NCT01018680", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "NSAID", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Osteoarthritis knee pain.", "note": "" }, { "nct": "NCT01020799", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Double-dummy; AZD7268 group (EG000) left out." }, { "nct": "NCT01027559", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Sertraline vs CBT; the healthy control group was not randomized and took no drug; no placebo." }, { "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": "Drug effects on periurethral sensation and urethral sphincter function.", "note": "Imipramine 25 mg vs lactose placebo for 14 days; pseudoephedrine, solifenacin, tamsulosin and cyclobenzaprine groups left out." }, { "nct": "NCT01032018", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression after acute coronary syndrome.", "note": "Stepped care, where patients chose problem-solving therapy and/or an antidepressant, vs referred usual care; no group randomized to an antidepressant and no placebo." }, { "nct": "NCT01032083", "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": "Negative symptoms of schizophrenia.", "note": "" }, { "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": "", "note": "" }, { "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": "Milnacipran plus education (EG001) has no placebo-plus-education group and is left out." }, { "nct": "NCT01041274", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "citalopram" ], "background": "psychoeducation; CBT if suicidal", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "First-episode schizophrenia; the acronym (Depression and Citalopram In First Episode Recovery) suggests depressive symptoms are also a target.", "note": "Psychoeducation, CBT for suicidality and fMRI are listed only under the placebo arm, but the trial is quadruple-masked, so they are taken as given to both arms." }, { "nct": "NCT01048944", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Nicotine dependence.", "note": "Placebo group took a placebo pill and a placebo patch; nicotine patch group (EG001) and the no-treatment delayed-quit control (EG003) left out." }, { "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": "", "note": "After 24 weeks of open-label DVS SR 50 mg (EG000), randomized to continue it (EG001), take 25 mg for 1 week then placebo (EG002, mixes exposures, left out), or switch abruptly to placebo (EG003)." }, { "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": "MDD with associated painful physical symptoms.", "note": "" }, { "nct": "NCT01077024", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in outpatients treated for cocaine or methamphetamine dependence.", "note": "Open-label smoking-cessation package (counseling, bupropion XL, nicotine inhaler, contingency management) plus usual care vs usual care alone; no placebo, and bupropion comes with other actives." }, { "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": "" }, { "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": "", "note": "Open-label phase (EG000) left out." }, { "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 the combination; placebo is used only for blinding, so there is no placebo group." }, { "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": "", "note": "Rhodiola rosea group (EG000) left out." }, { "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.", "note": "" }, { "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": "The placebo arm's intervention is listed as escitalopram, but it is described as inert placebo." }, { "nct": "NCT01106456", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Pharmacotherapy (varenicline, bupropion or NRT) offered to everyone, then randomized to a culturally tailored or a non-tailored program; no antidepressant randomized, no placebo." }, { "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.", "note": "" }, { "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 schizophrenia.", "note": "Varenicline group (EG001) left out." }, { "nct": "NCT01111539", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG004" ], "molecules": [ "escitalopram" ], "background": "aripiprazole", "combination": null } ], "design": "other", "indication": "depressive", "indication_note": "", "note": "Incomplete responders to 8 weeks of single-blind escitalopram (EG000) were randomized; escitalopram plus aripiprazole (EG002) vs aripiprazole with a blinded capsule (EG004) differ only in escitalopram, continued vs stopped. Escitalopram monotherapy (EG003) has only an active comparator; Phase B+ responders (EG001) were not randomized. Design other: randomized after a single-blind lead-in among non-responders." }, { "nct": "NCT01111552", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG004" ], "placebo_groups": [ "EG003" ], "molecules": [ "escitalopram" ], "background": "aripiprazole", "combination": null } ], "design": "other", "indication": "depressive", "indication_note": "", "note": "Incomplete responders to 8 weeks of single-blind escitalopram (EG000) were randomized; aripiprazole plus escitalopram (EG004) vs aripiprazole plus matching placebo (EG003) differ only in escitalopram, continued vs stopped. Escitalopram monotherapy (EG002) has only an active comparator; Phase B+ responders (EG001) were not randomized. Design other: randomized after a single-blind lead-in among non-responders." }, { "nct": "NCT01111565", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG004" ], "molecules": [ "escitalopram" ], "background": "aripiprazole", "combination": null } ], "design": "other", "indication": "depressive", "indication_note": "", "note": "Incomplete responders to 8 weeks of single-blind escitalopram (EG000) were randomized; aripiprazole plus escitalopram (EG002) vs aripiprazole monotherapy (EG004) differ only in escitalopram, continued vs stopped. No escitalopram placebo is named, but the study is double-blind. Escitalopram monotherapy (EG003) has only an active comparator; Phase B+ responders (EG001) were not randomized. Design other: randomized after a single-blind lead-in among non-responders." }, { "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 older adults.", "note": "" }, { "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": "MDD in peri- and postmenopausal women.", "note": "" }, { "nct": "NCT01124188", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with back pain in older adults; back pain is a co-target.", "note": "Higher-dose venlafaxine in both arms; compares problem-solving therapy with supportive management; no placebo." }, { "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": "PTSD.", "note": "" }, { "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": "", "note": "323U66 SR is GSK's code for bupropion SR; the record names only the code and tests it for MDD." }, { "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": "", "note": "Duloxetine 60 mg is an antidepressant reference arm, pooled with vortioxetine." }, { "nct": "NCT01145755", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Double-dummy; AZD2066 group (EG000) left out." }, { "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": "", "note": "All groups span the same 9 weeks: vortioxetine groups end with a blinded placebo week, duloxetine with a 30 mg taper week." }, { "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": "", "note": "" }, { "nct": "NCT01178671", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "mirtazapine" ], "background": "sertraline", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD.", "note": "Tests mirtazapine added to sertraline; sertraline is background on both sides." }, { "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": "", "note": "" }, { "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 (CGT)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Complicated grief (prolonged grief, a trauma- and stressor-related condition).", "note": "2x2 factorial: citalopram or placebo, each with CGT or grief-focused clinical management; one comparison per psychotherapy background." }, { "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": "Taper groups (EG002, EG003) re-count the randomized participants in the 1-week taper and are left out." }, { "nct": "NCT01189812", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depressive mood disorders (MDD, dysthymia, depression NOS); borderline personality disorder is also listed.", "note": "Citalopram 20 mg in both arms; lithium vs placebo." }, { "nct": "NCT01206478", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "amitriptyline" ], "background": "megestrol from visit 2 (week 10)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic oral food refusal in young children, read as a feeding disorder (DSM-5 feeding and eating disorders); a medical reading would make it non_psychiatric.", "note": "The placebo arm is labeled active comparator but is placebo plus the megestrol both arms get." }, { "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 and minocycline", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Symptom burden of chemoradiation for head and neck cancer.", "note": "2x2x2 factorial of armodafinil, minocycline and bupropion; one comparison per background. Matching placebos aren't named outside the placebo arm, but the trial is triple-masked, so groups without bupropion are taken as no added drug in a double-blind design." }, { "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": "Depression after traumatic brain injury (prevention and treatment); cognitive recovery is also a target.", "note": "ae_note: no adverse events of any type occurred." }, { "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": "" }, { "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": "Extension groups (EG002, EG003; placebo switched to duloxetine) and taper groups (EG004, EG005; the placebo taper also holds participants coming off the lowest duloxetine dose) left out." }, { "nct": "NCT01235338", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "Healthy volunteers (pharmacokinetic interaction study).", "note": "Open-label drug-interaction study of lisdexamfetamine and venlafaxine XR in two sequences; the AE groups are dosing periods, not randomized arms; no placebo. Design other: sequential dosing periods." }, { "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.", "note": "Open-label extension and taper groups (EG002 to EG005) left out." }, { "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": "", "note": "Three-arm: levomilnacipran ER, SSRI arm (randomized to one of paroxetine, sertraline, citalopram or fluoxetine; pooled in one AE group), placebo. Both antidepressant groups against placebo." }, { "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": "Vortioxetine arms had 8 weeks of drug then 2 weeks of blinded placebo discontinuation; placebo arm had placebo for the whole 10 weeks. All randomized double-blind arms over the same period." }, { "nct": "NCT01265550", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Refractory GERD. 'Medical Treatment Group' is omeprazole plus baclofen and/or desipramine (one AE group mixing baclofen and desipramine exposures); placebo group is omeprazole plus placebo. Desipramine never isolated against placebo; baclofen not given to placebo. Also a surgical arm and an all-enrolled pre-randomization group. Masking listed as none." }, { "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 pregnant smokers (tobacco use disorder).", "note": "" }, { "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": "", "note": "TC-5214 (S-mecamylamine, a nicotinic channel blocker under investigation for MDD) groups EG000/EG001 left out: an investigational drug of another class, not described in the record as an antidepressant. Duloxetine 60 mg active-control arm against placebo, both monotherapy." }, { "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": "" }, { "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 male volunteers (phase 1 neurotransmitter study); no condition treated.", "note": "Single-blind phase 1; placebo-matching capsules for 14 days." }, { "nct": "NCT01299896", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Health-services trial: usual care vs coordinated care for smoking cessation; no arm randomized to an antidepressant or placebo." }, { "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 and adolescents with autism spectrum / pervasive developmental disorders.", "note": "" }, { "nct": "NCT01303861", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline, after a nicotine-patch pre-quit phase (patch non-responders)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Nicotine dependence (smoking cessation).", "note": "Adaptive design: smokers who did not respond to pre-cessation nicotine patches were assigned to varenicline or varenicline plus bupropion; masking is double, so varenicline alone is taken as 'no added drug in a double-blind design' (record lists no bupropion placebo; unclear). Patch responder arms (EG001, EG002) and the dropped-before-assignment group (EG004) left out." }, { "nct": "NCT01312922", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "citalopram" ], "background": "pipamperone (antipsychotic) in both", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "PNB01 is a fixed-dose combination of pipamperone and citalopram; the pipamperone arm (sham comparator) gets pipamperone alone, double-blind, so PNB01 vs pipamperone differs only in citalopram. Assumes the same pipamperone dose in both (record gives no doses); if not, ineligible. No placebo arm; citalopram-alone arm (EG001) left out, as it lacks the pipamperone background." }, { "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": "" }, { "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 adults with asthma (depression with a medical illness).", "note": "Randomized within severity strata (HRSD and steroid courses); each stratum's escitalopram and placebo groups kept as their own comparison. They could equally be pooled." }, { "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": "Primary fibromyalgia in adolescents.", "note": "EG000 is the open-label milnacipran dose-escalation/treatment period (left out); EG002 vs EG001 are the double-blind randomized withdrawal groups." }, { "nct": "NCT01330030", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "selegiline" ], "background": "none", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Tobacco use disorder (nicotine dependence).", "note": "Transdermal selegiline 6 mg/24 h patch vs matching placebo patch." }, { "nct": "NCT01330043", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation.", "note": "Both arms get open-label bupropion plus nicotine patch (varenicline for some) and CBT; the randomized contrast is extended vs non-extended CBT. Timing of randomization not stated (arms read as randomized at the start)." }, { "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": "Adults with autism spectrum disorder / Asperger syndrome.", "note": "" }, { "nct": "NCT01347541", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Posttraumatic stress disorder in injured trauma survivors.", "note": "Open-label stepped care (CBT, motivational interviewing, unnamed 'FDA-approved anti-anxiety medications') vs standard care; no placebo and no named antidepressant group." }, { "nct": "NCT01348542", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Chronic insomnia (sleep-wake disorder).", "note": "Open-label trazodone 50 mg vs cognitive behavioral therapy; no placebo." }, { "nct": "NCT01354314", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "paroxetine" ], "background": "none (double-dummy placebos)", "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 from HIV infection). Coded non_psychiatric because the codebook counts only behavioural symptoms of neurocognitive disorders as psychiatric; DSM-5 does list neurocognitive disorder due to HIV, so other_psychiatric is arguable.", "note": "2x2 factorial with double-dummy placebo: paroxetine vs placebo, and paroxetine+fluconazole vs fluconazole (paroxetine placebo)." }, { "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": "" }, { "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 low-dose paroxetine mesylate." }, { "nct": "NCT01364649", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Well-treated MDD with SSRI-induced sexual dysfunction; patients switched antidepressant and sexual function was the outcome.", "note": "Vortioxetine vs escitalopram, no placebo arm." }, { "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 (depression with a medical illness); conditions also name other comorbid psychiatric conditions.", "note": "" }, { "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": "Groups include the 1-week blinded taper (placebo taper in the placebo group)." }, { "nct": "NCT01372150", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "fluoxetine", "desvenlafaxine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Pediatric MDD (7-17 years).", "note": "Fluoxetine is a reference arm for assay sensitivity; both antidepressant groups against placebo. Groups include a 1-week blinded taper/transition." }, { "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 is titled 80 mg though its description repeats 40 mg (apparent typo)." }, { "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 pregnant smokers.", "note": "" }, { "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 pain.", "note": "" }, { "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": "Laboratory fear-conditioning model of learned fear and anxiety after trauma; the record frames it as prevention of trauma-related anxiety. Participants appear to be volunteers without a named disorder, so non_psychiatric is arguable.", "note": "" }, { "nct": "NCT01406223", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline after a pre-quit nicotine patch week; placebo patch", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Nicotine dependence (smoking cessation).", "note": "Varenicline + bupropion vs varenicline + placebo bupropion (both also placebo patch after pre-cessation NRT): differ only in bupropion. NRT-only (EG001) and post-quit NRT (EG003) groups get placebo bupropion and placebo varenicline but differ in other active drugs, so left out." }, { "nct": "NCT01409382", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Pregnancy outcomes (maternal lifestyle, neonatal hypoglycemia).", "note": "Lifestyle counseling vs standard prenatal follow-up; no antidepressant in any arm." }, { "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 hot flashes (vasomotor symptoms).", "note": "Low-dose estradiol arm (EG000) is a non-antidepressant active comparator, left out." }, { "nct": "NCT01421342", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD not responding to an antidepressant (treatment-resistant).", "note": "VAST-D, open-label: switch to bupropion vs augment current antidepressant with bupropion vs with aripiprazole; no placebo." }, { "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 with cognitive dysfunction.", "note": "" }, { "nct": "NCT01427608", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "Psychotic depression (MDD with psychotic features).", "note": "Remitted patients on sertraline + olanzapine randomized to continue olanzapine or switch it to placebo; sertraline is background in both arms and the withdrawn drug is the antipsychotic." }, { "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": "Groups include the 1-week blinded taper (placebo taper for placebo and 50 mg groups)." }, { "nct": "NCT01436149", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to a prospective antidepressant course.", "note": "Lisdexamfetamine (SPD489) vs placebo added to an ongoing antidepressant (escitalopram, sertraline, venlafaxine XR or duloxetine) in both arms; the trial tests the stimulant. Add-on randomized after the antidepressant lead-in." }, { "nct": "NCT01436162", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to a prospective antidepressant course.", "note": "Lisdexamfetamine (SPD489) vs placebo added to an ongoing antidepressant (escitalopram, sertraline, venlafaxine XR or duloxetine) in both arms; the trial tests the stimulant." }, { "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": "" }, { "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": "" }, { "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 history of psychiatric disorders.", "note": "Triple-dummy: varenicline (EG000) and nicotine patch (EG002) are non-antidepressant active comparators, left out. AE collection ran to 30 days after the last dose." }, { "nct": "NCT01469377", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to antidepressant therapy.", "note": "Cariprazine (antipsychotic) vs placebo added to each participant's ongoing antidepressant; the trial tests cariprazine." }, { "nct": "NCT01471379", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Irritable bowel syndrome.", "note": "Delayed start: group C got placebo for 6 weeks then milnacipran 50 mg BID for 6 weeks, and its AE group covers all 12 weeks (mixes placebo and drug exposure). Groups A and B are milnacipran throughout; no placebo-only group." }, { "nct": "NCT01473381", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "vilazodone", "citalopram" ], "background": "none (double-dummy placebos)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Vilazodone 20 and 40 mg and citalopram 40 mg (active reference, an antidepressant) all against placebo; groups include the week-11 down-taper." }, { "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": "Groups include the week-9 down-taper; other AEs reported for the 8-week double-blind period." }, { "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 cause of intellectual disability and autism (neurodevelopmental); the record names only the syndrome, so non_psychiatric is arguable.", "note": "Liquid sertraline vs liquid placebo for six months." }, { "nct": "NCT01479829", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Bipolar depression.", "note": "Escitalopram plus celecoxib vs escitalopram plus placebo; escitalopram is background in both arms and the trial tests celecoxib." }, { "nct": "NCT01488071", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to prior antidepressant treatment.", "note": "Vortioxetine vs agomelatine, both antidepressants; no placebo." }, { "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": "Chronic knee osteoarthritis pain; title also mentions mood changes as an outcome.", "note": "" }, { "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": "Prolonged exposure + sertraline vs prolonged exposure + placebo (double-blind) differ only in sertraline. Sertraline + enhanced medication management (EG000) has no placebo counterpart with the same background, left out." }, { "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." }, { "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 (substance use disorder).", "note": "Official title mentions a 'serotonin medication combination', but arms and AE groups list only citalopram 20 or 40 mg vs placebo for 9 weeks; any shared background is not stated." }, { "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 (persistent depressive disorder).", "note": "" }, { "nct": "NCT01545843", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "All arms get fluoxetine 20-40 mg for 8 weeks; the randomized contrast is partial sleep deprivation schedules vs 8 hours in bed. Single-blind." }, { "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": "Groups include the 1-week blinded taper." }, { "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": "Knee osteoarthritis pain (brain morphometry study).", "note": "" }, { "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 with cognitive dysfunction.", "note": "Duloxetine is the active reference (an antidepressant); both antidepressant groups against placebo." }, { "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 Japanese male volunteers (phase 1 pharmacokinetics).", "note": "LY110140 is fluoxetine hydrochloride. Multiple-dose cohorts 4 (20 mg) and 5 (40 mg) for 28 days against the placebo group pooled from both cohorts. Single-dose cohorts 1-3 (EG000-EG002) have no placebo group reported, left out." }, { "nct": "NCT01571453", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Vortioxetine 10 mg vs venlafaxine XR 150 mg; no placebo." }, { "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 (cannabis) dependence.", "note": "" }, { "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": "Prevention of childhood and adolescent migraine.", "note": "Topiramate arm (EG000) is a non-antidepressant active comparator, left out. All capsules blinded." }, { "nct": "NCT01592695", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Cigarette smoking in rural veterans with comorbid depression, alcohol use or obesity; smoking cessation is the target.", "note": "Tailored behavioral program vs enhanced standard care (quitline referral); in both arms pharmacotherapy (NRT, bupropion SR, varenicline, or combinations) was chosen by preference, so no group was randomized to an antidepressant and none to placebo." }, { "nct": "NCT01598298", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "aromatase inhibitor therapy for early breast cancer", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Aromatase inhibitor-associated musculoskeletal pain in early-stage breast cancer.", "note": "Only AEs judged possibly, probably or definitely related to study drug were reported." }, { "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 and obesity with cardiovascular risk factors (cardiovascular outcomes trial).", "note": "NB32 is the naltrexone SR/bupropion SR combination product. Safety data are from database lock after the 50% interim analysis." }, { "nct": "NCT01608295", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Geriatric major depressive disorder.", "note": "Vilazodone vs paroxetine, double-blind; no placebo." }, { "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 (depression with a medical illness).", "note": "" }, { "nct": "NCT01611155", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "venlafaxine" ], "background": "FOLFOX (oxaliplatin) chemotherapy", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Prevention of oxaliplatin-induced peripheral neuropathy.", "note": "" }, { "nct": "NCT01621009", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "counseling or medication checks, balanced across arms by the 2x2 factorial", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Tobacco dependence (smoking cessation).", "note": "2x2 factorial (bupropion vs placebo x counseling vs none); AE groups pool the counseling factor, so active vs placebo medication margins are compared." }, { "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": "" }, { "nct": "NCT01635218", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG002" ], "molecules": [ "fluoxetine" ], "background": "none (double-dummy: homeopathic placebo in both)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Moderate to severe depression in peri- and postmenopausal women.", "note": "Individualized homeopathy arm (EG000) is not an antidepressant, left out." }, { "nct": "NCT01651442", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Primary insomnia and insomnia comorbid with psychiatric disorders.", "note": "Open-label sequenced (two-stage) design: behavioral therapy vs zolpidem first, then second-line therapies; trazodone group is second-stage medication after zolpidem. No placebo." }, { "nct": "NCT01658228", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression with mild cognitive impairment; the randomized donepezil add-on targets the cognitive impairment.", "note": "16 weeks of open-label citalopram or venlafaxine, then randomized double-blind add-on donepezil vs placebo while all continue the antidepressant. AE groups are the donepezil and placebo groups." }, { "nct": "NCT01662297", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Insomnia in veterans with a mental health and a substance use disorder.", "note": "Open-label stay-switch trial: remain on quetiapine vs switch to trazodone; no placebo." }, { "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": "" }, { "nct": "NCT01681849", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD in women with early childhood abuse.", "note": "3 months double-blind paroxetine vs placebo, then 3 months open-label paroxetine for both groups; the AE groups are described over both phases, so the placebo group mixes placebo and open-label paroxetine. Would be eligible (EG000 vs EG001) if the AE tables cover only the double-blind phase; the record doesn't say. PTSD-negative group (EG002) is a non-randomized baseline-only control." }, { "nct": "NCT01687478", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Nonpsychotic treatment-resistant depression.", "note": "Olanzapine + fluoxetine vs placebo + fluoxetine: fluoxetine is in both arms and the randomized contrast is olanzapine." }, { "nct": "NCT01691105", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Tobacco use in hospitalized smokers.", "note": "Health IT implementation trial: academic detailing vs academic detailing plus an order set offering NRT, bupropion and varenicline; no group randomized to an antidepressant or placebo, and AEs were not monitored." }, { "nct": "NCT01703039", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Sertraline 100 mg plus riluzole vs sertraline plus placebo; sertraline is in both arms and the trial tests riluzole." }, { "nct": "NCT01714310", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "fluoxetine" ], "background": "open-label lisdexamfetamine (stimulant)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Severe mood dysregulation in youth (chronic irritability), the construct DSM-5 recast as disruptive mood dysregulation disorder, which it classes among depressive disorders; other_psychiatric is arguable since the target is irritability rather than depressed mood.", "note": "All participants titrated on open-label lisdexamfetamine for 4 weeks (EG002, left out), then randomized to adjunctive fluoxetine or placebo through week 12 while continuing lisdexamfetamine; randomization starts the antidepressant exposure, so coded acute (add-on)." }, { "nct": "NCT01714323", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in hospitalized smokers.", "note": "Sustained care (free medication of the participant's choice: NRT, bupropion or varenicline, plus IVR counseling) vs standard care; open-label, no group randomized to an antidepressant or placebo, and AEs were not systematically assessed." }, { "nct": "NCT01715805", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to antidepressant therapy.", "note": "After an 8-week ADT + single-blind placebo lead-in, randomized to cariprazine or placebo added to ADT; the antidepressant is background in all arms. Lead-in and continued-treatment groups are not randomized arms." }, { "nct": "NCT01740726", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Adolescent major depressive disorder.", "note": "Behavioral activation vs fluoxetine; no placebo." }, { "nct": "NCT01748955", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with suicide attempt or suicidal ideation (high-risk depression).", "note": "Bupropion XL vs paroxetine CR, both antidepressants; no placebo." }, { "nct": "NCT01764386", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Overweight and obesity.", "note": "Open-label naltrexone/bupropion combination product with comprehensive lifestyle intervention vs usual care (self-directed lifestyle); no placebo, and the lifestyle background differs. EG002 pools all subjects over the whole study." }, { "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": "" }, { "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 from disc disease.", "note": "" }, { "nct": "NCT01778686", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Healthy volunteers (PET radioligand evaluation).", "note": "Intravenous citalopram is given together with oral pindolol (beta blocker / 5-HT1A antagonist), which the placebo group doesn't get; third arm is acute tryptophan depletion. Interventions precede a second PET scan, so the exposure is brief." }, { "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": "" }, { "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 no AE data. By design escitalopram (EG001) vs placebo (EG000) would be a clean comparison." }, { "nct": "NCT01802385", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "sertraline" ], "background": "amphotericin plus fluconazole for cryptococcal meningitis", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "HIV-associated cryptococcal meningitis (infection).", "note": "Placebo arm is labeled no-intervention but its description says standard therapy plus placebo (quadruple masking); the sertraline dosing text in EG000's description looks like an intervention-description artifact. Non-serious AEs can't be separated by term; SAEs were collected." }, { "nct": "NCT01802437", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "Adolescent depression.", "note": "Adaptive (SMART) design: interpersonal psychotherapy, with non-responders at a 4- or 8-week decision point re-randomized to more IPT or added fluoxetine. No placebo; AE groups are by decision point and mix fluoxetine and psychotherapy-only exposures." }, { "nct": "NCT01803711", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD in patients with medical illness (cancer, diabetes, cardiovascular disease).", "note": "Desvenlafaxine plus omega-3 vs desvenlafaxine plus placebo; desvenlafaxine is in both arms and the trial tests omega-3 (2 and 3 randomized)." }, { "nct": "NCT01806779", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline, after a 1-week nicotine patch run-in", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Nicotine dependence (smoking cessation) in male smokers.", "note": "After a 1-week nicotine patch run-in (EG002, everyone, left out), randomized to varenicline vs varenicline + bupropion; masking is double, so varenicline alone is taken as 'no added drug in a double-blind design' (record lists no bupropion placebo; unclear)." }, { "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": "MDD in Japanese patients.", "note": "LY110140 is fluoxetine. Treatment-period groups used. The 2-week discontinuation-period groups (EG003-EG005) are the same participants all on placebo, left out." }, { "nct": "NCT01838681", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "MDD with inadequate response to antidepressant treatment.", "note": "Brexpiprazole vs placebo adjunct to open-label ADT in a long-term maintenance-of-efficacy study (randomized withdrawal of brexpiprazole, as the title implies); the antidepressant is background in both arms." }, { "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": "" }, { "nct": "NCT01846182", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "duloxetine" ], "background": "none (double-dummy AM/PM placebo)", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Gulf War illness (chronic multisymptom illness) in veterans.", "note": "Pregabalin arm (EG001) is a non-antidepressant active comparator, left out. The record's AE note says event collection appears inadequate and the data unreliable." }, { "nct": "NCT01850589", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in a vascular surgery practice.", "note": "Conservative counseling (NRT offered) vs an aggressive program with pharmacotherapy offered; no group randomized to an antidepressant or placebo." }, { "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": "Groups include the week-15 blinded taper." }, { "nct": "NCT01856270", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Prevention of post-traumatic headache after traumatic brain injury.", "note": "Open-label amitriptyline started immediately vs at day 30 (delayed start, no placebo); the delayed group's AE data would include its time on amitriptyline." }, { "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 tobacco treatment counseling, with optional cessation medication; no group randomized to an antidepressant or placebo." }, { "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 (12-17 years).", "note": "" }, { "nct": "NCT01901848", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people with PTSD; both targets are other_psychiatric.", "note": "Cognitive processing therapy + integrated smoking cessation care vs integrated care alone; bupropion and NRT are given in both arms, and the trial tests the psychotherapy." }, { "nct": "NCT01902004", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Geriatric depression with mild cognitive impairment.", "note": "Open-label escitalopram in both arms plus memantine vs placebo; the trial tests memantine." }, { "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": "Placebo track: blinded citalopram (EG001) vs blinded placebo (EG002). Open-track citalopram (EG000) is open-label with no open placebo counterpart, left out." }, { "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 (60-90 years).", "note": "Double-blind escitalopram (EG001) vs double-blind placebo (EG000). Open-label escitalopram group (EG002) has no open placebo counterpart, left out." }, { "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": "", "note": "Double-blind phase groups only; open-label extension groups (EG002, EG003) and taper groups (EG004; EG005 mixes placebo and duloxetine tapers) left out." }, { "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": "", "note": "First (double-blind) phase only; second-phase groups are open-label fluvoxamine for everyone." }, { "nct": "NCT01943435", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Medical care arm gives individualized NSAIDs, analgesics or antidepressants at the physician's discretion; no arm randomized to a named antidepressant, and no placebo. Parallel arms randomized at the start (non-drug comparators)." }, { "nct": "NCT01977729", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "", "note": "Open-label: children not responding to CBT randomized to CBT plus sertraline or switch to sertraline alone; no placebo. Design is a sequential randomization after a CBT phase." }, { "nct": "NCT01987960", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Paroxetine or sertraline is open-label background in both arms; the trial tests adjunctive brexpiprazole (an antipsychotic) against placebo. Add-on randomized design." }, { "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": "Screening-strategy trial: screen-and-treat arm offers CBT/problem-solving therapy or unspecified antidepressant medication by preference (stepped care); no arm randomized to an antidepressant and no placebo." }, { "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": "", "note": "Doubly randomized (sequential parallel) design: only Period 1, randomized at the start, is used (esketamine 14/28/56/84 mg vs placebo). Period 2 re-randomizes the same Period 1 placebo non-responders (EG002-EG006), EG005/EG007/EG010 pool panels and responders, and EG011-EG018 are open-label or follow-up groups; all left out. No background antidepressant stated in the record." }, { "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": "", "note": "" }, { "nct": "NCT02005601", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "total knee arthroplasty", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Perioperative duloxetine for sub-acute pain after knee arthroplasty." }, { "nct": "NCT02014363", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Citalopram lead-in non-responders randomized to ETS6103 (investigational, tested for antidepressant activity; two doses) or amitriptyline; no placebo arm either way. Lead-in not reported as an AE group." }, { "nct": "NCT02015546", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "All three arms switch to vilazodone with different initiation doses; no placebo." }, { "nct": "NCT02017535", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "", "note": "Continuation phase of an adaptive strategy: groups assigned by acute-phase response (IPT alone, IPT plus continued, new or increased fluoxetine); no placebo, and arms are not randomized drug-versus-placebo arms." }, { "nct": "NCT02021669", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Sertraline 50 mg in both arms; trial tests omega-3 (EPA) against corn-oil placebo." }, { "nct": "NCT02046564", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "ASC-01 is aripiprazole/sertraline; comparator is placebo/sertraline 100 mg, so sertraline is in both arms and the trial tests aripiprazole." }, { "nct": "NCT02050308", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Open-label web-program trial; both arms choose among varenicline, bupropion and nicotine replacement, so no arm is randomized to an antidepressant and there is no placebo." }, { "nct": "NCT02052739", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "", "note": "Open-label SAGE-547 (brexanolone) at two doses as adjunct for super-refractory status epilepticus; no placebo arm. Dose groups, not a placebo-controlled design." }, { "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": "", "note": "Cocaine dependence (substance use)." }, { "nct": "NCT02082392", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Four randomized arms (escitalopram or placebo by visit frequency), but the AE groups are by visit frequency only and each pools escitalopram and placebo participants." }, { "nct": "NCT02088697", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "", "note": "Single-dose crossover bioequivalence study in healthy men: 'ASC-01 placebo' is aripiprazole 0 mg/sertraline 100 mg, so both groups receive sertraline; no placebo." }, { "nct": "NCT02090998", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Open-label amitriptyline versus sphenopalatine ganglion block with lidocaine for transformed migraine; no placebo." }, { "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)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Bupropion XL vs placebo randomized; the contingency-management type was assigned at week 6 by urine results, after randomization, so both strata are pooled into one comparison to keep the randomized contrast. Cocaine dependence." }, { "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": "", "note": "Double-blind phase groups only; follow-up phase groups (EG002, EG003) are the same participants off study drug and are left out." }, { "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": "", "note": "Cognitively normal older adults; mechanistic CSF amyloid-beta study. Placebo group pools 2- and 8-week durations, matching the escitalopram groups." }, { "nct": "NCT02181231", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Venlafaxine XR continues in both arms; trial randomizes add-on buprenorphine vs placebo." }, { "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 taken as main.", "note": "" }, { "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": "", "note": "Smoking cessation in pregnant women." }, { "nct": "NCT02191397", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Double-dummy bupropion XL versus escitalopram; both arms are antidepressants and there is no placebo." }, { "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": "", "note": "Sham rTMS plus fluoxetine vs sham rTMS plus placebo. EG000 adds active rTMS, which the placebo group doesn't get, so it is left out. Motor recovery after acute stroke." }, { "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": "", "note": "Doxepin oral rinse (topical route) vs placebo rinse for oral mucositis pain; DLA rinse arm (EG002) is an active comparator and is left out." }, { "nct": "NCT02229825", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Duloxetine 60 mg vs 120 mg (placebo capsules only as dummies); no placebo arm." }, { "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": "" }, { "nct": "NCT02238977", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in end-stage renal disease on hemodialysis.", "note": "Open-label bupropion vs fluoxetine, no placebo; the fluoxetine arm recruited no one." }, { "nct": "NCT02245308", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Open-label smoking-cessation programs; bupropion is one optional cessation aid in both arms, not a randomized assignment, and there is no placebo." }, { "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": "", "note": "Chronic knee osteoarthritis pain." }, { "nct": "NCT02260388", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Open-label comparative effectiveness: nortriptyline, duloxetine, pregabalin, mexiletine for cryptogenic sensory polyneuropathy; no placebo." }, { "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": "", "note": "Open-label run-in/stabilization group (EG000) left out; comparison is the double-blind relapse-prevention phase." }, { "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; eating disorder taken as main.", "note": "Naltrexone 50 mg plus bupropion 300 mg daily vs placebo. Called a 'combination', but those doses can't come from the fixed-dose naltrexone/bupropion product (8/90 mg tablets), so it reads as two drugs given together; the placebo group gets neither. If a reader treats it as the combination product, the comparison is EG000 vs EG001 with combination naltrexone." }, { "nct": "NCT02327013", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Two-stage design re-randomizing placebo non-responders: vortioxetine 10 and 20 mg groups (EG001, EG002) also hold placebo-to-vortioxetine switchers, and the placebo group (EG000) keeps only those who stayed on placebo, so the groups mix exposures. Stage 1 was randomized at the start." }, { "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 depression.", "note": "Blinded 8-week phase only; open-label bupropion for non-remitters (EG002) pools both arms after randomization and is left out." }, { "nct": "NCT02357849", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "", "note": "Fluoxetine vs aripiprazole for attenuated psychosis syndrome; no placebo." }, { "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 CBT; no placebo. Engagement-interview and observational groups have no AE data." }, { "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": "", "note": "Open-label vortioxetine 10 mg period (EG000) left out. The 'Double-blind: Vortioxetine 20 mg' arm is typed PLACEBO_COMPARATOR in the record, but its description and AE group (EG004) are vortioxetine 20 mg." }, { "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": "Pediatric major depressive disorder.", "note": "Fluoxetine is the active control but is itself an antidepressant, so both drug groups go against placebo." }, { "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": "", "note": "Young children with autism spectrum disorder." }, { "nct": "NCT02389465", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Late-life depression.", "note": "All depressed participants get escitalopram; the randomized contrast is add-on celecoxib vs placebo. The healthy-control group is non-depressed, unmedicated and not a randomized arm." }, { "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." }, { "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": "", "note": "Lu AA21004 is vortioxetine." }, { "nct": "NCT02407704", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Open-label venlafaxine XR in every arm (groups split by age band); the randomized contrast is added aerobic exercise vs none." }, { "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": "Double-blind induction groups only; post-treatment follow-up groups (EG003-EG005) left out. Placebo arm is typed ACTIVE_COMPARATOR but is intranasal placebo plus the same oral antidepressant." }, { "nct": "NCT02417935", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Double-dummy duloxetine vs pregabalin for diabetic peripheral neuropathic pain; no placebo arm." }, { "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; post-treatment follow-up groups (EG002, EG003) left out." }, { "nct": "NCT02420015", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in people with schizophrenia; both tobacco use and schizophrenia are other_psychiatric.", "note": "Open-label; both arms get nicotine replacement plus bupropion and counseling; the trial tests mobile contingency management and related components." }, { "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 groups (EG002, EG003) left out." }, { "nct": "NCT02424188", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in serious mental illness (main), with weight management and exercise.", "note": "Multicomponent intervention offering varenicline or bupropion plus NRT vs treatment as usual (quit-line referral); no arm is randomized to an antidepressant and there is no placebo." }, { "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": "Fluoxetine is the active control but is itself an antidepressant, so it joins the levomilnacipran groups against placebo." }, { "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": "", "note": "Chronic laryngitis / laryngeal neuropathy." }, { "nct": "NCT02458690", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in older adults at cardiovascular risk (depression with a medical illness).", "note": "Collaborative stepped care (CBT and algorithm-chosen antidepressants by preference) vs usual care; no arm randomized to a specific antidepressant and no placebo." }, { "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 depression.", "note": "" }, { "nct": "NCT02477618", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "brexanolone" ], "background": "standard care for super-refractory status epilepticus (anaesthetic weaning)", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "SAGE-547 is brexanolone, used here for status epilepticus (not as an anaesthetic). EG001's description also mentions open-label 150 ug/kg/h dosing for blinded-treatment non-responders; the record doesn't say whose open-label AEs fall in which group, so a little open-label exposure may be mixed in." }, { "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.", "note": "Maintenance phase: stable esketamine-treated participants randomized to continue esketamine (EG002) or switch to intranasal placebo (EG003); EG003's description says 'transferred-entry' but the arm text says direct- and transferred-entry participants were assigned to placebo. Left out: open-label induction/optimization (EG000, EG001), the transferred-entry placebo track of earlier-trial placebo responders (EG006, EG007), and follow-up (EG004, EG005)." }, { "nct": "NCT02501265", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "", "note": "Adaptive smoking-cessation pharmacotherapy: bupropion is added only for non-responders in the adaptive arms (by response, not randomized), and each AE group pools them with responders on placebo bupropion; adaptive arms also start active varenicline/patch earlier than standard arms. No group is randomized to bupropion vs placebo." }, { "nct": "NCT02504931", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "COPE therapy (prolonged-exposure-based CBT)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Dual diagnosis PTSD and alcohol use disorder; both other_psychiatric.", "note": "Placebo arm states it also gets COPE; the sertraline arm's matching sentence is truncated ('Subjects in the Sertraline arm al...') but reads as the same COPE background." }, { "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 arm (EG000) is a non-drug active comparator and is left out." }, { "nct": "NCT02520726", "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": "Prevention of PTSD after burn injury.", "note": "" }, { "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": "" }, { "nct": "NCT02535000", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "elective spine surgery", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "", "note": "Two perioperative doses for postoperative pain. Arm types are swapped in the record (placebo typed EXPERIMENTAL), but the groups are clear." }, { "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": "", "note": "Chronic laryngitis." }, { "nct": "NCT02579343", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram (Lexapro) in both arms; the trial tests auricular acupuncture vs sham acupuncture." }, { "nct": "NCT02593396", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "methadone maintenance", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Sexual dysfunction in men on methadone maintenance; the codebook lists sexual dysfunction as non_psychiatric.", "note": "" }, { "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." }, { "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 (depression with a medical illness).", "note": "" }, { "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": "", "note": "Placebo group's description says placebo non-responders were offered 8-12 weeks of SSRI after the 8-week placebo trial; the record doesn't say whether AEs in that period are counted in EG001, so the placebo group may include some SSRI exposure." }, { "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": "Posttraumatic stress disorder.", "note": "AE note says only treatment-related adverse events at a 5% threshold were reported." }, { "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 or obesity with cardiovascular disease (cardiovascular outcomes trial).", "note": "Fixed-dose naltrexone/bupropion ER combination tablets vs matching placebo. A 2-week tolerability lead-in (one week each of drug and placebo) preceded randomization and is not an AE group. AE collection was limited to SAEs, AEs leading to discontinuation and special-interest AEs." }, { "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 taken as main.", "note": "" }, { "nct": "NCT02655354", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD after injury (main), with depression, alcohol use and other comorbidity.", "note": "Pragmatic stepped collaborative-care intervention (care management, MI, CBT elements, psychotropics chosen flexibly, many antidepressants among them) vs enhanced usual care; no arm randomized to a specific antidepressant and no placebo." }, { "nct": "NCT02674529", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "escitalopram" ], "background": "real-time neurofeedback fMRI task before and after treatment", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "" }, { "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: usual-care cessation monotherapy vs extended bupropion plus NRT combination (with or without home visits); no placebo, and the bupropion arms also add NRT." }, { "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 for 12 weeks in both arms; the randomized contrast is D-cycloserine vs placebo in weeks 6-12. AEs were not assessed." }, { "nct": "NCT02709655", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002", "EG003", "EG004" ], "placebo_groups": [ "EG001" ], "molecules": [ "vortioxetine", "fluoxetine" ], "background": "brief psychosocial intervention (BPI) sessions", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Pediatric major depressive disorder (ages 7-11).", "note": "Single-blind 4-week placebo lead-in (EG000) left out; comparison is the double-blind period. Fluoxetine is the active reference but an antidepressant, so it joins vortioxetine against placebo (recruitment to the fluoxetine arm was stopped early)." }, { "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": "Pediatric major depressive disorder (ages 12-17).", "note": "Single-blind placebo lead-in group of patients not randomized (EG000) left out. EG003 is titled fluoxetine 20 mg though its description repeats the vortioxetine text (copy error); fluoxetine is the active reference and an antidepressant." }, { "nct": "NCT02720198", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "SSRI inadequate responders randomized to switch to levomilnacipran or add quetiapine XR to their SSRI; no placebo." }, { "nct": "NCT02736474", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Weight loss (listed first) and smoking cessation in obese smokers with schizophrenia; obesity taken as main, smoking cessation co-primary.", "note": "Separate naltrexone tablets and bupropion capsules vs both placebos; not a single combination product, and the placebo group gets no naltrexone." }, { "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": "" }, { "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": "Anxiety and depressive symptoms in COPD or interstitial lung disease; both listed, with anxiety first and the drug named as an antidepressant; depression taken as main but anxiety (other_psychiatric) is equally plausible.", "note": "" }, { "nct": "NCT02917122", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Depression in Parkinson's disease.", "note": "Open-label sertraline in both arms; the trial tests active vs sham tDCS." }, { "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; double-blind follow-up (EG004-EG007), post-treatment (EG008-EG011) and open-label groups (EG012, EG013) left out. Placebo arm is typed EXPERIMENTAL in the record." }, { "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 as a SUDEP biomarker).", "note": "" }, { "nct": "NCT02932904", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002", "EG003" ], "placebo_groups": [ "EG000" ], "molecules": [ "paroxetine", "vortioxetine" ], "background": "none", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "Healthy volunteers (study of sexual functioning).", "note": "Paroxetine is the active control but an antidepressant, so it joins vortioxetine 10 and 20 mg against placebo." }, { "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." }, { "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." }, { "nct": "NCT02960763", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant late-life depression.", "note": "Single-blind augment-or-switch strategies (aripiprazole, bupropion or lithium augmentation; switch to bupropion or nortriptyline) on top of or replacing current antidepressants; no placebo." }, { "nct": "NCT02977299", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "Treatment-resistant depression.", "note": "Aripiprazole augmentation vs rTMS augmentation vs switch to venlafaxine/duloxetine; no placebo." }, { "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) is the placebo-controlled comparison; Part A (EG000, 15/20 mg oral solution) has no concurrent placebo arm and is left out." }, { "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 randomized Part A open-label responders to continue SAGE-217 or switch to placebo for 7 days; open-label Parts A (EG000, EG001) and C (EG004) left out." }, { "nct": "NCT02995915", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Concurrent smoking cessation and alcohol use.", "note": "Open-label; both arms get the same telephone CBT and cessation pharmacotherapy (NRT and bupropion); the trial tests mobile contingency management vs monitoring." }, { "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": "", "note": "SAGE-217 is zuranolone. Double-blind Part B only; open-label Part A (EG000) left out." }, { "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 HIV.", "note": "Sertraline 400 mg/day used for antifungal effect." }, { "nct": "NCT03024606", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "Smoking cessation in pregnancy.", "note": "Text-message program vs none, both on usual care with NRT or bupropion; no arm randomized to an antidepressant and no placebo." }, { "nct": "NCT03033069", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "sertraline" ], "background": "none (matching placebos)", "combination": null }, { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "sertraline" ], "background": "brexpiprazole", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Posttraumatic stress disorder.", "note": "Double-dummy 2x2 of brexpiprazole and sertraline: sertraline vs placebo, and brexpiprazole plus sertraline vs brexpiprazole alone (brexpiprazole is background on both sides of the second comparison)." }, { "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 on male fertility (semen parameters); 'Depression' is listed as a condition but the study targets fertility, not depression.", "note": "" }, { "nct": "NCT03039192", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "esketamine" ], "background": "comprehensive standard of care with an initiated or optimized oral antidepressant", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with suicidal ideation at imminent risk for suicide.", "note": "" }, { "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 counseling", "combination": "naltrexone" } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "Binge eating disorder (main) with obesity.", "note": "2x2 factorial of BWL counseling and naltrexone/bupropion (NB, 32/360 mg/day, the Contrave doses) vs placebo; one comparison per BWL background." }, { "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 (main) with obesity.", "note": "Maintenance trial: participants randomized to naltrexone/bupropion (32/360 mg/day) or placebo for 16 weeks after acute treatment; the record doesn't say whether everyone had first received NB, so it isn't clearly a randomized-withdrawal design." }, { "nct": "NCT03063606", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "other", "indication": "other_psychiatric", "indication_note": "Binge eating disorder (main) with obesity.", "note": "This trial randomizes added CBT vs no CBT; the AE groups are instead split by blinded naltrexone/bupropion or placebo carried over from an earlier acute-stage randomization, so they are not this trial's randomized arms, and entry into this stage came after that randomization." }, { "nct": "NCT03090152", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "Pain after total hip replacement for osteoarthritis.", "note": "Duloxetine is part of the multimodal analgesic regimen in every arm; the trial compares periarticular injection, epidural PCA, or both." }, { "nct": "NCT03097133", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "esketamine" ], "background": "standard-of-care oral antidepressant treatment chosen by the physician", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "Major depressive disorder with suicidal ideation at imminent risk for suicide.", "note": "" }, { "nct": "NCT03126682", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "MDD treated with ECT", "note": "Both groups get bupropion (Wellbutrin SR), differing only in which ECT session it accompanies; no placebo group. Design is a timing comparison within ECT, not drug vs placebo." }, { "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 MDD", "note": "Placebo arm (dosed like escitalopram) was dropped on 5/16/18 and participants were then randomized to escitalopram or levomilnacipran, so levomilnacipran (EG001) appears never to have been randomized against placebo and is left out; part of the escitalopram group was enrolled after placebo ended. EG003 is open-label escitalopram for placebo non-responders, left out." }, { "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 or obesity", "note": "Both arms get bupropion; the trial tests naltrexone vs placebo added to it (separate drugs, not one product)." }, { "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 use)", "note": "" }, { "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 in women with breast or gynecologic cancer (sexual dysfunction)", "note": "" }, { "nct": "NCT03185819", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with imminent suicide risk in children and adolescents", "note": "Comparator gets oral midazolam (a benzodiazepine used as active placebo) that the esketamine groups don't; all arms get standard-of-care antidepressant. FU-phase groups (EG004-EG007) are post-treatment follow-up." }, { "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 names only the code); the bupropion comparator is an antidepressant and is pooled." }, { "nct": "NCT03249558", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "duloxetine" ], "background": "extended-release morphine", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "chronic low back or neck pain", "note": "EG002 (duloxetine with placebo morphine) has no double-placebo group to match and is left out." }, { "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": "pain and opioid use after total knee arthroplasty", "note": "" }, { "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 (not a DSM-5 disorder)", "note": "" }, { "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": "CBT arm (EG000) left out." }, { "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": "depressive disorder in children and adolescents", "note": "" }, { "nct": "NCT03321006", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "late-life depression with hearing loss", "note": "Both arms get escitalopram or duloxetine; the trial tests full vs sham hearing aids." }, { "nct": "NCT03321526", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with inadequate response to SSRI/SNRI", "note": "All continue their SSRI/SNRI; the trial compares seltorexant (JNJ-42847922) with quetiapine XR and has no placebo arm. Follow-up groups are post-treatment." }, { "nct": "NCT03328832", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "blood loss in total knee arthroplasty", "note": "No antidepressant in any arm (tranexamic acid, Floseal, rivaroxaban)." }, { "nct": "NCT03342027", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG002" ], "molecules": [ "bupropion" ], "background": "Positively Smoke Free behavioural treatment", "combination": null }, { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "standard-of-care brief advice to quit", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation in people living with HIV", "note": "2x2 factorial: bupropion vs placebo by behavioural treatment." }, { "nct": "NCT03374956", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "obesity", "note": "Phenotype-guided vs randomly assigned anti-obesity drugs (naltrexone/bupropion among them); no placebo, and each group mixes drugs." }, { "nct": "NCT03388164", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Both arms get escitalopram 10 mg; the trial tests RT2CK17 vs placebo in the same capsule." }, { "nct": "NCT03429075", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Escitalopram (with 1 mg psilocybin) vs psilocybin 25 mg with placebo tablets; the comparator is a psychedelic, no placebo group." }, { "nct": "NCT03431831", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "obesity, with or without food addiction", "note": "Contrave (naltrexone-bupropion) arms vs diet and activity usual care or counselling with no placebo; groups are split by food-addiction status." }, { "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." }, { "nct": "NCT03464383", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "anxiety and depression in epilepsy; depression taken as the main target", "note": "Escitalopram (venlafaxine XR if not tolerated) started by the epileptologist vs psychiatry referral; no placebo. Survey arm is not randomized." }, { "nct": "NCT03466346", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "depressive", "indication_note": "MDD with PTSD; depression taken as main", "note": "SMART: fluoxetine vs interpersonal psychotherapy, non-remitters re-randomized to second-line treatment; no placebo." }, { "nct": "NCT03471767", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking and nicotine dependence", "note": "AXS-05 (dextromethorphan-bupropion) vs bupropion SR; both antidepressants, no placebo." }, { "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 and male infertility", "note": "" }, { "nct": "NCT03534063", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "postoperative pain after arthroplasty", "note": "CYP2D6-guided opioid prescribing vs usual care; antidepressants are mentioned only as CYP2D6 inhibitors." }, { "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 people on haemodialysis", "note": "CBT-I arm (EG000) left out." }, { "nct": "NCT03538691", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "randomized_withdrawal", "indication": "depressive", "indication_note": "", "note": "All get antidepressant therapy; after open-label stabilization the trial randomizes continuing brexpiprazole (an antipsychotic) vs placebo." }, { "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": "" }, { "nct": "NCT03548454", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "chronic pain", "note": "Open-label duloxetine vs desipramine; no placebo." }, { "nct": "NCT03569475", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "levomilnacipran", "fluoxetine" ], "background": "none (8-week double-blind treatment period)", "combination": null }, { "antidepressant_groups": [ "EG004", "EG005" ], "placebo_groups": [ "EG003" ], "molecules": [ "levomilnacipran", "fluoxetine" ], "background": "none (1-week double-blind down-taper period)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD in children and adolescents", "note": "AEs are reported separately for the treatment period and the blinded down-taper, so the second comparison holds the same participants as the first; fluoxetine is an antidepressant comparator, pooled." }, { "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: venlafaxine added to gabapentin, methadone and oxycodone vs the same regimen with no placebo." }, { "nct": "NCT03575403", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001", "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "laboratory alcohol and methylphenidate doses", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "alcohol use disorder (human laboratory study)", "note": "EG001 (30 mg) had 2 participants whose data the ae_note says are not reported, so its counts may be missing rather than zero." }, { "nct": "NCT03588572", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "subcortical aphasia after ischaemic stroke", "note": "Control gets no drug and no placebo (single-blind)." }, { "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": "hypoglycaemia unawareness in type 1 diabetes", "note": "" }, { "nct": "NCT03595579", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "AXS-05 (dextromethorphan-bupropion) vs bupropion; both antidepressants, no placebo." }, { "nct": "NCT03670316", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation in people with HIV", "note": "Algorithm-guided cessation drugs vs quitline referral; open-label, mixed drugs, no placebo." }, { "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 (the record names only the code). Follow-up and extended follow-up groups (EG003-EG008) are after treatment ended and are left out." }, { "nct": "NCT03771664", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "zuranolone" ], "background": "single-blind placebo before and after the double-blind days", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "MDD with comorbid insomnia", "note": "SAGE-217 is zuranolone." }, { "nct": "NCT03799198", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "obesity", "note": "Weight programme plus any of five weight-loss drugs (Contrave among them) vs the programme alone; open-label, mixed, no placebo." }, { "nct": "NCT03812588", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG000" ], "molecules": [ "escitalopram" ], "background": "clinical-frequency management (monthly visits)", "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 by escitalopram vs placebo." }, { "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 haemorrhage", "note": "" }, { "nct": "NCT03844412", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "nortriptyline" ], "background": "lidocaine/estradiol cream", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "nortriptyline" ], "background": "placebo cream", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "vestibulodynia", "note": "2x2 factorial: cream vs placebo cream by nortriptyline vs placebo pill." }, { "nct": "NCT03854578", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "citalopram" ], "background": "single dose of BI 1358894-matching placebo", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Single-dose citalopram vs placebo. BI 1358894 (EG002) is investigational and EG003 is an as-treated mixed group; both left out. Groups are as treated: one patient randomized to BI 1358894 who got placebo sits in EG000." }, { "nct": "NCT03897439", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation", "note": "Optimized care (nicotine patch with adaptive varenicline or bupropion) vs nicotine patch; open-label, mixed, no placebo." }, { "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": "" }, { "nct": "NCT03946111", "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 with obesity", "note": "Per the title, entrants had not responded to earlier treatment; randomized at entry to naltrexone/bupropion or placebo." }, { "nct": "NCT03950427", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation in serious mental illness", "note": "All arms get bupropion and counselling; the trial tests active vs sedentary videogames." }, { "nct": "NCT03978442", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD with cigarette smoking", "note": "Both arms get bupropion; the trial tests contingent vs yoked incentives." }, { "nct": "NCT03979820", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "healthy volunteers, tyramine pressor test", "note": "Phenelzine is an open-label positive control on its own schedule; the placebo group is matched to BI 1467335 (28 days, tyramine later), so phenelzine has no placebo. EG000 is everyone at screening." }, { "nct": "NCT03993457", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "CRP-consistent vs CRP-inconsistent choice of escitalopram or bupropion; no placebo." }, { "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": "" }, { "nct": "NCT04094870", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "perinatal depression in women with HIV", "note": "Sertraline vs interpersonal therapy; no placebo." }, { "nct": "NCT04103892", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "esketamine" ], "background": "current standard antidepressant (Part A, 1 week)", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "esketamine" ], "background": "current standard antidepressant (Part B, 4 weeks)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "adjunctive treatment of MDD", "note": "CLE-100 is oral esketamine. Parts A and B each have their own placebo group; taken as separate cohorts." }, { "nct": "NCT04124614", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD", "note": "Both arms get sertraline 150 mg; the trial tests brexpiprazole." }, { "nct": "NCT04167306", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "bupropion" ], "background": "varenicline", "combination": null }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "none (varenicline placebo)", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "alcohol use disorder", "note": "2x2 factorial of varenicline and bupropion." }, { "nct": "NCT04174170", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD", "note": "All arms get sertraline 150 mg; the trial tests brexpiprazole 2 or 3 mg." }, { "nct": "NCT04178993", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "duloxetine" ], "background": "methylphenidate and laboratory methamphetamine or placebo doses", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "methamphetamine use disorder (human laboratory study)", "note": "" }, { "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-traumatic headache after concussion", "note": "" }, { "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, both with ongoing SSRI/SNRI; no placebo." }, { "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": "COVID-19", "note": "" }, { "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 per the interventions." }, { "nct": "NCT04352101", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "", "note": "Bupropion vs escitalopram; no placebo." }, { "nct": "NCT04395001", "eligible": false, "exclusion_reason": "antidepressant_is_background", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "chronic pain", "note": "All arms get duloxetine; the trial tests web CBT and nurse support." }, { "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": "tinnitus", "note": "Each active arm is one listed drug (nortriptyline+topiramate in EG000, verapamil+paroxetine in EG001) titrated in a fixed ratio against a single placebo pill, so taken as one compounded product per arm. If they were separate drugs, both groups would be excluded as combined with another active drug." }, { "nct": "NCT04436289", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "post-hospital care for people with and without HIV", "note": "Home-visit intervention vs usual care; no antidepressant." }, { "nct": "NCT04437485", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "depression with prediabetes", "note": "Collaborative stepped care (CBT and antidepressants) vs education and usual care; no placebo, mixed exposures." }, { "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." }, { "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." }, { "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) vs internet CBT-I vs both; no placebo." }, { "nct": "NCT04476030", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "zuranolone" ], "background": "newly assigned open-label antidepressant (sertraline, escitalopram, citalopram, duloxetine or desvenlafaxine)", "combination": null } ], "design": "acute", "indication": "depressive", "indication_note": "", "note": "SAGE-217 is zuranolone; study drug for 14 days, the antidepressant continued to day 42 in both groups." }, { "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": "COVID-19", "note": "Factorial: metformin vs placebo by ivermectin vs fluvoxamine vs placebo. The placebo groups pool fluvoxamine and ivermectin placebos. Ivermectin groups (EG002, EG005) left out." }, { "nct": "NCT04531176", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "obesity with type 2 diabetes", "note": "Weight programme plus one of four weight-loss drugs (naltrexone/bupropion among them) vs programme alone vs usual care; open-label, mixed, no placebo." }, { "nct": "NCT04537806", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "brexanolone" ], "background": "mechanical ventilation and standard ICU care", "combination": null } ], "design": "acute", "indication": "non_psychiatric", "indication_note": "ARDS due to COVID-19", "note": "Brexanolone given as a 60-hour infusion for ARDS, not as an anaesthetic." }, { "nct": "NCT04597190", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "PTSD", "note": "Sequenced strategies of SSRI, venlafaxine and written exposure therapy; no placebo." }, { "nct": "NCT04599478", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG000" ], "placebo_groups": [ "EG001" ], "molecules": [ "bupropion" ], "background": "behavioural weight loss counselling", "combination": "naltrexone" }, { "antidepressant_groups": [ "EG002" ], "placebo_groups": [ "EG003" ], "molecules": [ "bupropion" ], "background": "none", "combination": "naltrexone" } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "loss-of-control eating after bariatric surgery, with weight outcomes", "note": "2x2 factorial of behavioural weight loss and naltrexone-bupropion." }, { "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", "note": "Monotherapy. Open-label treatment, observation and follow-up groups (EG003-EG007) left out." }, { "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", "note": "Maintenance stage (2a) after an acute stage; the record doesn't say what entrants had taken, so this may be a randomized withdrawal of naltrexone-bupropion or a new randomization." }, { "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": "COVID-19", "note": "" }, { "nct": "NCT04760652", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "MDD with suicidal ideation after esketamine", "note": "CBT vs treatment as usual after esketamine; no antidepressant randomized." }, { "nct": "NCT04798664", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "smoking cessation", "note": "Usual care, cost removal, incentive and app arms; bupropion only possibly prescribed outside the study; no placebo; AEs not collected." }, { "nct": "NCT04850222", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "prevention of mental health decline after musculoskeletal trauma; conditions list only the injury", "note": "Comparator is calcium supplementation, an active substance rather than placebo (single-blind)." }, { "nct": "NCT04876521", "eligible": false, "exclusion_reason": "active_comparator_only", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "post-schizophrenic depression", "note": "Olanzapine-fluoxetine vs amisulpride; no placebo." }, { "nct": "NCT04885530", "eligible": false, "exclusion_reason": "groups_not_randomized_arms", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "COVID-19", "note": "Master platform record: each AE group pools an appendix's active drug and its placebo ('Fluvoxamine or Placebo'); appendix AE data are posted under their own NCT IDs." }, { "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": "MDD in children aged 7 to 11", "note": "Open-label lead-in group EG000 left out." }, { "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", "note": "" }, { "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 apnoea, which DSM-5 lists among sleep-wake disorders (breathing-related); otherwise a medical condition", "note": "AD504 is an atomoxetine tablet plus a trazodone capsule; EG004 pools the atomoxetine-alone and atomoxetine-plus-placebo-capsule arms, so it differs only in trazodone. AD109 (atomoxetine-aroxybutynin) and plain placebo groups left out." }, { "nct": "NCT05277207", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "other_psychiatric", "indication_note": "tobacco use", "note": "Personalized cessation drugs and counselling vs telehealth referral; open-label, mixed, no placebo." }, { "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 cancer; the record doesn't state the targeted outcome", "note": "" }, { "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", "note": "The ae_note says AEs were not posted (low enrollment), so counts may be missing rather than zero." }, { "nct": "NCT05464979", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "intubation of critically ill ICU patients", "note": "Esketamine given IV only as an anaesthetic induction agent, vs midazolam and fentanyl." }, { "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 dementia (behavioural symptoms of a neurocognitive disorder)", "note": "AXS-05 is dextromethorphan-bupropion (the record names only the code)." }, { "nct": "NCT05575128", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "perioperative depression and anxiety in older adults having cardiac procedures", "note": "Behavioural activation plus medication review vs usual care; no antidepressant randomized, no placebo." }, { "nct": "NCT05579249", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "obesity", "note": "Semaglutide vs clinician-chosen anti-obesity drugs (naltrexone/bupropion among them); open-label, mixed, no placebo." }, { "nct": "NCT05658874", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "acute", "indication": "non_psychiatric", "indication_note": "chronic pelvic pain and interstitial cystitis", "note": "Multimodal care bundle (amitriptyline or gabapentin among other treatments) vs usual care; open-label, no placebo." }, { "nct": "NCT05685511", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "perioperative depression and anxiety in older adults having cancer surgery", "note": "Behavioural activation plus medication review vs usual care; no antidepressant randomized, no placebo." }, { "nct": "NCT05697835", "eligible": false, "exclusion_reason": "no_antidepressant_group", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "perioperative depression and anxiety in older adults having orthopaedic surgery", "note": "Behavioural activation plus medication review vs usual care; no antidepressant randomized, no placebo." }, { "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; its AE group is the matched placebo. Open-label use after the randomized period collected no data." }, { "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": "COVID-19", "note": "ACTIV-6 appendix, arm B (50 mg)." }, { "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": "COVID-19", "note": "ACTIV-6 appendix, arm E (100 mg)." }, { "nct": "NCT05976646", "eligible": true, "exclusion_reason": null, "comparisons": [ { "antidepressant_groups": [ "EG001" ], "placebo_groups": [ "EG000" ], "molecules": [ "dextromethorphan-bupropion" ], "background": "buprenorphine/naloxone", "combination": null } ], "design": "acute", "indication": "other_psychiatric", "indication_note": "opioid use disorder", "note": "Auvelity is dextromethorphan-bupropion; 7-day drug-interaction study." }, { "nct": "NCT06001021", "eligible": false, "exclusion_reason": "combined_with_other_active", "comparisons": [], "design": "acute", "indication": "depressive", "indication_note": "perinatal depression and anxiety in couples", "note": "The medication arm allows an SSRI and/or alprazolam, which the placebo group doesn't get; combined arms add couple therapy. The ae_note also says the placebo group's AEs were not assessed." }, { "nct": "NCT06192589", "eligible": false, "exclusion_reason": "no_placebo_group", "comparisons": [], "design": "other", "indication": "non_psychiatric", "indication_note": "healthy volunteers; cannabidiol liver enzymes and drug interactions", "note": "Citalopram appears only in a Part 2 interaction cohort that also gets cannabidiol; the only placebo is Part 1's cannabidiol placebo." }, { "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": "adjunctive treatment of MDD", "note": "CLE-100 is oral esketamine." } ]