{"protocolSection":{"identificationModule":{"nctId":"NCT00824291","orgStudyIdInfo":{"id":"3151A1-4415"},"secondaryIdInfos":[{"id":"B2061006"}],"organization":{"fullName":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder","officialTitle":"A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release"},"statusModule":{"statusVerifiedDate":"2011-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-02"},"primaryCompletionDateStruct":{"date":"2009-10","type":"ACTUAL"},"completionDateStruct":{"date":"2009-11","type":"ACTUAL"},"studyFirstSubmitDate":"2009-01-14","studyFirstSubmitQcDate":"2009-01-15","studyFirstPostDateStruct":{"date":"2009-01-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-10-26","resultsFirstSubmitQcDate":"2010-10-26","resultsFirstPostDateStruct":{"date":"2010-11-25","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-03-04","lastUpdatePostDateStruct":{"date":"2011-03-10","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Director, Clinical Trial Disclosure Group","oldOrganization":"Pfizer, Inc"},"leadSponsor":{"name":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks."},"conditionsModule":{"conditions":["Depressive Disorder, Major"],"keywords":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":437,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: desvenlafaxine succinate sustained release"]},{"label":"2","type":"EXPERIMENTAL","interventionNames":["Genetic: Genotyping"]}],"interventions":[{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"50 mg/day oral tablet for 12 weeks","armGroupLabels":["1"],"otherNames":["Pristiq"]},{"type":"GENETIC","name":"Genotyping","description":"CYP2D6 genotyping at randomization","armGroupLabels":["2"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12","description":"HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.","timeFrame":"At Baseline and Week 12."}],"secondaryOutcomes":[{"measure":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12","description":"Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10.","timeFrame":"At Baseline and Week 12."},{"measure":"Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12","description":"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.","timeFrame":"At Baseline and Week 12."},{"measure":"Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12","description":"CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.","timeFrame":"At Baseline and Week 12."},{"measure":"Change From Baseline on Work and Activities Item of HAM-D17 at Week 12","description":"The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.","timeFrame":"At Baseline and Week 12."},{"measure":"Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12","description":"Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","timeFrame":"At Baseline and Week 12."},{"measure":"Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12","description":"WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.","timeFrame":"At Baseline and Week 12."},{"measure":"Change From Baseline on Stress and Social Support Scales at Week 12","description":"Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.","timeFrame":"At Baseline and Week 12."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.\n* Employed for 20 hours or more for a minimum of 1 month prior to baseline.\n* Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.\n\nExclusion Criteria:\n\n* Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.\n* Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of \\>=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).\n* Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.\n* Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.","healthyVolunteers":false,"sex":"ALL","minimumAge":"19 Years","maximumAge":"74 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}]},"referencesModule":{"references":[{"pmid":"34183490","type":"DERIVED","citation":"Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435."},{"pmid":"29140227","type":"DERIVED","citation":"Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15."},{"pmid":"27009044","type":"DERIVED","citation":"Reddy S, Fayyad R, Edgar CJ, Guico-Pabia CJ, Wesnes K. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2016 Jun;30(6):559-67. doi: 10.1177/0269881116631649. Epub 2016 Mar 23."},{"pmid":"26709542","type":"DERIVED","citation":"McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13."},{"pmid":"26644956","type":"DERIVED","citation":"McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015."},{"pmid":"25758058","type":"DERIVED","citation":"Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26."},{"pmid":"25012446","type":"DERIVED","citation":"Endicott J, Lam RW, Hsu MA, Fayyad R, Boucher M, Guico-Pabia CJ. Improvements in quality of life with desvenlafaxine 50mg/d vs placebo in employed adults with major depressive disorder. J Affect Disord. 2014 Sep;166:307-14. doi: 10.1016/j.jad.2014.05.011. Epub 2014 May 21."},{"pmid":"24583567","type":"DERIVED","citation":"Lam RW, Endicott J, Hsu MA, Fayyad R, Guico-Pabia C, Boucher M. Predictors of functional improvement in employed adults with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2014 Sep;29(5):239-51. doi: 10.1097/YIC.0000000000000031."},{"pmid":"24571916","type":"DERIVED","citation":"Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-4415&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20In%20Outpatients%20With%20Major%20Depressive%20Disorder"}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"A total of 752 potential participants were screened for this study. 437 participants were randomized to treatment groups while 315 participants were not randomized (288: did not meet the study criteria; 27 were not randomized for other reasons). Of the 437 randomized participants, 10 participants did not receive the study treatment.","groups":[{"id":"FG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"FG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"285"},{"groupId":"FG001","numSubjects":"142"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"231"},{"groupId":"FG001","numSubjects":"107"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"35"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Discontinuation of Study by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Non-compliance","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Participant on prohibited medication","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"BG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"285"},{"groupId":"BG001","value":"142"},{"groupId":"BG002","value":"427"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.16","spread":"11.72"},{"groupId":"BG001","value":"41.57","spread":"12.64"},{"groupId":"BG002","value":"42.63","spread":"12.04"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"188"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"281"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"97"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"146"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12","description":"HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.","populationDescription":"Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Scores on a scale","timeFrame":"At Baseline and Week 12.","groups":[{"id":"OG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"OG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.61","spread":"0.45"},{"groupId":"OG001","value":"-10.50","spread":"0.60"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.78","ciUpperLimit":"3.46"}]},{"type":"SECONDARY","title":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12","description":"Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10.","populationDescription":"ITT, LOCF","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Scores on a scale","timeFrame":"At Baseline and Week 12.","groups":[{"id":"OG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"OG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.41","spread":"0.48"},{"groupId":"OG001","value":"-8.08","spread":"0.63"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.067","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"1.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"2.76"}]},{"type":"SECONDARY","title":"Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12","description":"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.","populationDescription":"ITT, LOCF","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Scores on a scale","timeFrame":"At Baseline and Week 12.","groups":[{"id":"OG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"OG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"142"}]}],"classes":[{"title":"1 (Very Much Improved)","categories":[{"measurements":[{"groupId":"OG000","value":"103","spread":"0.07"},{"groupId":"OG001","value":"31","spread":"0.10"}]}]},{"title":"2 (Much Improved)","categories":[{"measurements":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"44"}]}]},{"title":"3 (Minimally Improved)","categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"31"}]}]},{"title":"4 (No Change)","categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"30"}]}]},{"title":"5 (Minimally Worse)","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"5"}]}]},{"title":"6 (Much Worse)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"7 (Very Much Worse)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","statisticalMethod":"Cochran-Mantel-Haenszel"}]},{"type":"SECONDARY","title":"Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12","description":"CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.","populationDescription":"ITT, LOCF","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Scores on a scale","timeFrame":"At Baseline and Week 12.","groups":[{"id":"OG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"OG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"142"}]}],"classes":[{"title":"1 (Very Much Improved)","categories":[{"measurements":[{"groupId":"OG000","value":"69","spread":"0.08"},{"groupId":"OG001","value":"23","spread":"0.11"}]}]},{"title":"2 (Much Improved)","categories":[{"measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"30"}]}]},{"title":"3 (Minimally Improved)","categories":[{"measurements":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"31"}]}]},{"title":"4 (No Change)","categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"43"}]}]},{"title":"5 (Minimally Worse)","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"15"}]}]},{"title":"6 (Much Worse)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"7 (Very Much Worse)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline on Work and Activities Item of HAM-D17 at Week 12","description":"The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.","populationDescription":"ITT, LOCF","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Scores on a scale","timeFrame":"At Baseline and Week 12.","groups":[{"id":"OG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"OG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.68","spread":"0.07"},{"groupId":"OG001","value":"-1.45","spread":"0.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.040","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.01","ciUpperLimit":"0.44"}]},{"type":"SECONDARY","title":"Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12","description":"Measures the overall severity of depressive symptoms. 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Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.","populationDescription":"ITT, LOCF","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Scores on a scale","timeFrame":"At Baseline and Week 12.","groups":[{"id":"OG000","title":"DVS SR 50 mg","description":"Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food."},{"id":"OG001","title":"Placebo","description":"Participants were administered an oral dose of placebo once daily with or without food."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"285"},{"groupId":"OG001","value":"142"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.39","spread":"0.79"},{"groupId":"OG001","value":"-10.95","spread":"1.04"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.041","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"2.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.10","ciUpperLimit":"4.78"}]},{"type":"SECONDARY","title":"Change From Baseline on Stress and Social Support Scales at Week 12","description":"Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 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