{"protocolSection":{"identificationModule":{"nctId":"NCT00519428","orgStudyIdInfo":{"id":"5476"},"secondaryIdInfos":[{"id":"5R01MH076961-04","type":"NIH","link":"https://reporter.nih.gov/quickSearch/5R01MH076961-04"}],"organization":{"fullName":"New York State Psychiatric Institute","class":"OTHER"},"briefTitle":"Does Dual Therapy Hasten Antidepressant Response?","officialTitle":"Combining Antidepressants to Hasten Remission From Depression"},"statusModule":{"statusVerifiedDate":"2017-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-08"},"primaryCompletionDateStruct":{"date":"2011-07","type":"ACTUAL"},"completionDateStruct":{"date":"2012-03","type":"ACTUAL"},"studyFirstSubmitDate":"2007-08-20","studyFirstSubmitQcDate":"2007-08-20","studyFirstPostDateStruct":{"date":"2007-08-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-10-06","resultsFirstSubmitQcDate":"2017-09-05","resultsFirstPostDateStruct":{"date":"2017-10-04","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-09-05","lastUpdatePostDateStruct":{"date":"2017-10-04","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"New York State Psychiatric Institute","class":"OTHER"},"collaborators":[{"name":"University of Ottawa","class":"OTHER"},{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will utilize a randomized double-blind design to evaluate whether initial treatment with two anti-depressant medications (escitalopram and bupropion) results in more rapid remission and greater over-all remission rates than either monotherapy in 240 depressed subjects.","detailedDescription":"Depression is a major public health problem due to its prevalence and accompanying dysfunction and costs. Depression is undertreated, but even when treatment is adequate and effective, sources of delay in current pharmacologic strategies include: mechanistic delays, those related to the physiologic and behavioral effects of antidepressants; dosing delays in identifying the effective dose; and programmatic delays in identifying an effective agent using sequential monotherapy. This study will randomize 240 patients with Diagnostic and Statistical Manual, 4th Edition (DSM-IV) Major Depressive Disorder (MDD) to 12 week double blind treatment with combined escitalopram and bupropion or each antidepressant administered alone to evaluate whether combined escitalopram and bupropion result in more rapid remission and greater over-all remission than monotherapy. Preclinical and clinical studies suggest that bupropion might prevent one mechanistic delay inherent in escitalopram monotherapy. Rapid dose escalation may counter dosing delays. The simultaneous use of two known antidepressant medications may alleviate programmatic delays inherent in usual sequential monotherapy. Six months follow up and careful assessment of adverse events will address tolerability, acceptability, sustainability, and pharmacoeconomic concerns. If successful, this study might have a significant impact on clinical practice, public health, and depression's cost consequences."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["depression","Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":245,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"escitalopram + bupropion","type":"EXPERIMENTAL","description":"escitalopram plus bupropion extra long (XL) as dual treatment (i.e., this is not a SINGLE treatment arm; all patients assigned this arm received both medications)","interventionNames":["Drug: escitalopram + bupropion"]},{"label":"escitalopram","type":"ACTIVE_COMPARATOR","description":"escitalopram monotherapy","interventionNames":["Drug: escitalopram"]},{"label":"bupropion","type":"ACTIVE_COMPARATOR","description":"bupropion extra long (XL) monotherapy","interventionNames":["Drug: bupropion extra long (XL)"]}],"interventions":[{"type":"DRUG","name":"escitalopram","description":"10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted","armGroupLabels":["escitalopram"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"bupropion extra long (XL)","description":"150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted","armGroupLabels":["bupropion"],"otherNames":["Wellbutrin extra long (XL)"]},{"type":"DRUG","name":"escitalopram + bupropion","description":"same dosing schedule as for monotherapy","armGroupLabels":["escitalopram + bupropion"],"otherNames":["Lexapro","Wellbutrin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7","description":"Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05.","timeFrame":"12 weeks"}],"secondaryOutcomes":[{"measure":"Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12","description":"Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items \\[HAMD-D 17\\] \\> 7 once HAMD-D 17 \\<= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate.","timeFrame":"12 weeks"},{"measure":"Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)","description":"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.\n\n0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression\n\n≥ 23 = Very Severe Depression","timeFrame":"12 weeks"},{"measure":"Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score","description":"Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning","timeFrame":"12 weeks"},{"measure":"Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)","description":"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).\n\nThe minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction.","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Men and women ages 18-65\n2. Major Depressive Disorder as primary diagnosis\n3. Physically healthy\n4. Signs informed consent\n5. Montgomery Asberg Depression Rating Scale (MADRS) \\>= 22\n\nExclusion Criteria:\n\n1. Bipolar Disorder (ie, Bipolar I, Bipolar II, Bipolar NOS)\n2. Life-time history of psychosis\n3. Current (ie, last 6 months) drug or alcohol abuse or dependence (except nicotine)\n4. Currently taking effective antidepressant medication\n5. Prior adequate treatment in current depressive episode with a selective serotonin re-uptake inhibitor (SSRI), bupropion (BUP) or bupropion (BUP) + a selective serotonin re-uptake inhibitor (SSRI) (\"adequate\" is defined as \\>= 4 weeks taking \\>= 2/3 Physician's Desk Reference (PDR) maximal dose\n6. Most recent antidepressant was within 5 weeks for fluoxetine and 1 week for all others\n7. Currently taking a medication contraindicated with either study medication\n8. Life time history of anorexia or bulimia\n9. Life time history of seizure or known increased seizure risk (e.g., history of significant brain trauma, taking pro-convulsant medication, known anatomical brain lesion)\n10. Currently taking psychoactive medication deemed to be necessary (including but not limited anticonvulsants, antidepressants, antipsychotics, steroids, and B-blockers); occasional use of hypnotics (ie, less than three times per week) will be allowed\n11. Unstable medical condition (ie, condition not adequately stabilized for \\>= 3 months)\n12. Prior intolerance to escitalopram (ESC) or bupropion (BUP)\n13. Inadequate understanding of English (for US site; Canadian site permits French fluency)\n14. Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jonathan W. Stewart, M.D.","affiliation":"New York State Psychiatric Institute","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Pierre Blier, M.D.","affiliation":"University of Ottawa","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"New York State Psychiatric Institute","city":"New York","state":"New York","zip":"10032","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"University of Ottawa, Institute of Mental Health Research","city":"Ottawa","state":"Ontario","zip":"K1Z7K4","country":"Canada","geoPoint":{"lat":45.41117,"lon":-75.69812}}]},"referencesModule":{"references":[{"pmid":"38628260","type":"DERIVED","citation":"van der Wijk G, Enkhbold Y, Cnudde K, Szostakiwskyj MW, Blier P, Knott V, Jaworska N, Protzner AB. One size does not fit all: notable individual variation in brain activity correlates of antidepressant treatment response. Front Psychiatry. 2024 Apr 2;15:1358018. doi: 10.3389/fpsyt.2024.1358018. eCollection 2024."},{"pmid":"25615566","type":"DERIVED","citation":"Weissman MM, Wickramaratne P, Pilowsky DJ, Poh E, Batten LA, Hernandez M, Flament MF, Stewart JA, McGrath P, Blier P, Stewart JW. Treatment of maternal depression in a medication clinical trial and its effect on children. Am J Psychiatry. 2015 May;172(5):450-9. doi: 10.1176/appi.ajp.2014.13121679. Epub 2015 Jan 23."},{"pmid":"25295437","type":"DERIVED","citation":"Gerra ML, Marchesi C, Amat JA, Blier P, Hellerstein DJ, Stewart JW. Does negative affectivity predict differential response to an SSRI versus a non-SSRI antidepressant? J Clin Psychiatry. 2014 Sep;75(9):e939-44. doi: 10.4088/JCP.14m09025."},{"pmid":"24485847","type":"DERIVED","citation":"Stewart JW, McGrath PJ, Blondeau C, Deliyannides DA, Hellerstein D, Norris S, Amat J, Pilowsky DJ, Tessier P, Laberge L, O'Shea D, Chen Y, Withers A, Bergeron R, Blier P. Combination antidepressant therapy for major depressive disorder: speed and probability of remission. J Psychiatr Res. 2014 May;52:7-14. doi: 10.1016/j.jpsychires.2013.12.001. Epub 2013 Dec 17."}],"seeAlsoLinks":[{"label":"Depression Evaluation Service official website","url":"http://depression-nyc.org/"},{"label":"Columbia University Depart,ment of Psychiatry web page","url":"https://www.columbiapsychiatry.org/"},{"label":"official website of the University of Ottawa's Institute of Mental Health Research","url":"http://www.imhr.ca"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All patients had to be psychoactive drug-free for at least two weeks (five weeks for fluoxetine) prior to randomization and had to continue to meet study entry criteria at point of randomization","recruitmentDetails":"Recruitment dates: August, 2007 to August 2011 Locations: 4 outpatient research clinics in two countries (US and Canada)","groups":[{"id":"FG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion"},{"id":"FG001","title":"Escitalopram","description":"escitalopram monotherapy"},{"id":"FG002","title":"Bupropion","description":"bupropion monotherapy"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"84"},{"groupId":"FG002","numSubjects":"83"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"58"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"25"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"10"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"unstated","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion XL"},{"id":"BG001","title":"Escitalopram","description":"escitalopram monotherapy"},{"id":"BG002","title":"Bupropion","description":"bupropion XL monotherapy"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"83"},{"groupId":"BG003","value":"245"}]}],"measures":[{"title":"Age, Continuous","description":"Patient's report of their age","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"title":"Age","categories":[{"measurements":[{"groupId":"BG000","value":"40","spread":"10"},{"groupId":"BG001","value":"41","spread":"11"},{"groupId":"BG002","value":"40","spread":"11"},{"groupId":"BG003","value":"40","spread":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"62"},{"groupId":"BG002","value":"49"},{"groupId":"BG003","value":"163"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"82"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"41"},{"groupId":"BG003","value":"120"}]}]},{"title":"Canada","categories":[{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"42"},{"groupId":"BG003","value":"125"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7","description":"Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05.","populationDescription":"age 18-65 with Major Depressive Disorder (MDD), non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate selective serotonin re-uptake inhibitor (SSRI) and/or bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"weeks","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion XL"},{"id":"OG001","title":"Escitalopram","description":"escitalopram monotherapy"},{"id":"OG002","title":"Bupropion","description":"bupropion XL monotherapy"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"83"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8","spread":"7"},{"groupId":"OG001","value":"9","spread":"7"},{"groupId":"OG002","value":"10","spread":"7"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy). Therefore each analysis will be done twice and it will be required that both analyses be significant to declare the over-all study significant.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy).","pValue":".05","pValueComment":"Each individual test will require the calculated \"p\" to be \\< .0916 to declare that comparison to be significant. Since the hypothesis requires both comparisons to be significant, this produces an over-all alpha of .05.","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Mean Difference (Final Values)","paramValue":".05","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_DEVIATION","dispersionValue":"4"}]},{"type":"SECONDARY","title":"Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12","description":"Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items \\[HAMD-D 17\\] \\> 7 once HAMD-D 17 \\<= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate.","populationDescription":"age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion XL"},{"id":"OG001","title":"Escitalopram","description":"escitalopram monotherapy"},{"id":"OG002","title":"Bupropion","description":"bupropion XL monotherapy"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"83"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"34"}]}]}]},{"type":"SECONDARY","title":"Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)","description":"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.\n\n0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression\n\n≥ 23 = Very Severe Depression","populationDescription":"age 18-65 with MDD, non-bipolar, non-psychotic, non-substance abusing, without intolerance to study drugs or adequate SSRI/bupropion treatment in current episode; physically healthy without contraindications to bupropion or escitalopram.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on Hamilton Rating Scale for Depre","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion XL"},{"id":"OG001","title":"Escitalopram","description":"escitalopram monotherapy"},{"id":"OG002","title":"Bupropion","description":"bupropion XL monotherapy"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10","spread":"8"},{"groupId":"OG001","value":"9","spread":"7"},{"groupId":"OG002","value":"12","spread":"8"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"To test the hypothesis that escitalopram + bupropion would have superior efficacy relative to each monotherapy, the group receiving both medications was separately compared to each monotherapy group, covarying for baseline score and country","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".0916","pValueComment":"escitalopram + bupropion vs. escitalopram: F(1,159) = 1.93, ns escitalopram + bupropion vs. bupropion: F (1,157) = 1.99, ns","statisticalMethod":"ANCOVA","statisticalComment":"adjusting for baseline score and country","paramType":"Mean Difference (Final Values)","paramValue":"10","ciPctValue":"95","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_DEVIATION","dispersionValue":"8"}]},{"type":"SECONDARY","title":"Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score","description":"Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning","populationDescription":"All randomized patients; latest available Total SAS score used if week 12 score not available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on the SAS scale","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion XL as dual treatment (i.e., this is not a SINGLE treatment arm; all patients assigned this arm received both medications)\n\nescitalopram + bupropion: same dosing schedule as for monotherapy"},{"id":"OG001","title":"Escitalopram","description":"escitalopram monotherapy\n\nescitalopram: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted"},{"id":"OG002","title":"Bupropion","description":"bupropion XL monotherapy\n\nbupropion XL: 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.65","spread":".69"},{"groupId":"OG001","value":"2.63","spread":".69"},{"groupId":"OG002","value":"2.74","spread":".71"}]}]}]},{"type":"SECONDARY","title":"Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)","description":"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).\n\nThe minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction.","populationDescription":"All Randomized Subjects","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on the Q-LES-Q scale","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion XL"},{"id":"OG001","title":"Escitalopram","description":"escitalopram monotherapy"},{"id":"OG002","title":"Bupropion","description":"bupropion XL monotherapy"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.0","spread":".82"},{"groupId":"OG001","value":"3.0","spread":".76"},{"groupId":"OG002","value":"3.1","spread":".74"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"12 weeks","description":"A modified Systematic Assessment for Treatment Emergent Events (SAFTEE) at each visit specifically asked about 17 items (too much energy, muscle tightness, insomnia, tremor, poor concentration, word finding, spacy, dizzy, headache, dry mouth, decreased appetite, nausea, low energy, sleepy, sweating, decreased libido, anger/irritability) a pilot study showed occurred in at least 10% of patients treated with escitalopram plus bupropion. A General Inquiry then asked re additional symptoms.","eventGroups":[{"id":"EG000","title":"Escitalopram + Bupropion","description":"escitalopram plus bupropion XL\n\nescitalopram + bupropion: same dosing schedule as for monotherapy","seriousNumAffected":0,"seriousNumAtRisk":78,"otherNumAffected":71,"otherNumAtRisk":78},{"id":"EG001","title":"Escitalopram","description":"escitalopram monotherapy\n\nescitalopram: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted","seriousNumAffected":0,"seriousNumAtRisk":84,"otherNumAffected":80,"otherNumAtRisk":84},{"id":"EG002","title":"Bupropion","description":"bupropion XL monotherapy\n\nbupropion XL: 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted","seriousNumAffected":0,"seriousNumAtRisk":83,"otherNumAffected":71,"otherNumAtRisk":83}],"otherEvents":[{"term":"Too much energy","organSystem":"General disorders","sourceVocabulary":"Too much energy","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"A feeling of being too \"revved up\"","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":78},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":84},{"groupId":"EG002","numEvents":7,"numAffected":7,"numAtRisk":83}]},{"term":"muscle tightness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"muscle tightness","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"a feeling of tenseness or tightness in the muscles","stats":[{"groupId":"EG000","numEvents":13,"numAffected":13,"numAtRisk":78},{"groupId":"EG001","numEvents":14,"numAffected":14,"numAtRisk":84},{"groupId":"EG002","numEvents":18,"numAffected":18,"numAtRisk":83}]},{"term":"insomnia","organSystem":"General disorders","sourceVocabulary":"insomnia","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"trouble falling asleep, staying asleep or waking too early","stats":[{"groupId":"EG000","numEvents":24,"numAffected":24,"numAtRisk":78},{"groupId":"EG001","numEvents":27,"numAffected":27,"numAtRisk":84},{"groupId":"EG002","numEvents":31,"numAffected":31,"numAtRisk":83}]},{"term":"tremor","organSystem":"Nervous system disorders","sourceVocabulary":"tremor","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"involuntary shaking or trembling","stats":[{"groupId":"EG000","numEvents":23,"numAffected":23,"numAtRisk":78},{"groupId":"EG001","numEvents":14,"numAffected":14,"numAtRisk":84},{"groupId":"EG002","numEvents":18,"numAffected":18,"numAtRisk":83}]},{"term":"trouble thinking","organSystem":"Nervous system disorders","sourceVocabulary":"cognitive disturbanc","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"trouble thinking or concentrating, cognitive 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