{"protocolSection":{"identificationModule":{"nctId":"NCT01432457","orgStudyIdInfo":{"id":"B2061028"},"secondaryIdInfos":[{"id":"3151A1-4420"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)","officialTitle":"A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-10"},"primaryCompletionDateStruct":{"date":"2012-07","type":"ACTUAL"},"completionDateStruct":{"date":"2012-08","type":"ACTUAL"},"studyFirstSubmitDate":"2011-09-09","studyFirstSubmitQcDate":"2011-09-09","studyFirstPostDateStruct":{"date":"2011-09-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-06-27","resultsFirstSubmitQcDate":"2013-12-17","resultsFirstPostDateStruct":{"date":"2014-01-20","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-12-17","lastUpdatePostDateStruct":{"date":"2014-01-20","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder."},"conditionsModule":{"conditions":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":924,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"desvenlafaxine succinate sustained-release 50 mg/day","type":"EXPERIMENTAL","interventionNames":["Drug: desvenlafaxine succinate sustained-release 50 mg/day"]},{"label":"desvenlafaxine succinate sustained-release 100 mg/day","type":"EXPERIMENTAL","interventionNames":["Drug: desvenlafaxine succinate sustained-release 100 mg/day"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"desvenlafaxine succinate sustained-release 50 mg/day","description":"50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper","armGroupLabels":["desvenlafaxine succinate sustained-release 50 mg/day"],"otherNames":["Pristiq"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained-release 100 mg/day","description":"100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day","armGroupLabels":["desvenlafaxine succinate sustained-release 100 mg/day"]},{"type":"DRUG","name":"placebo","description":"50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). 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Change from baseline: score at observation minus score at baseline","timeFrame":"Baseline to Week 8 (final on-therapy)"}],"secondaryOutcomes":[{"measure":"Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)","description":"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.","timeFrame":"Baseline to Week 8 (final on-therapy)"},{"measure":"Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)","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). 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A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.","timeFrame":"Baseline to Week 8 (final on-therapy)"},{"measure":"Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. 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However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.\n\nEach individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.","timeFrame":"Baseline to Week 8 (final on-therapy)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female outpatients aged 18 years or older who are fluent in written and spoken English.\n* A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.\n* A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.\n\nExclusion Criteria:\n\n* Significant risk of suicide based on clinical judgment.\n* Current (within 12 months before baseline) 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* Current generalized anxiety disorder, panic disorder, or social anxiety disorder.\n* History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.\n* Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Dedicated Clinical Research","city":"Phoenix","state":"Arizona","zip":"85020","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Deidcated Clinical Research","city":"Phoenix","state":"Arizona","zip":"85020","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Arkansas Psychiatric Clinic Clinical Research Trials, P.A.","city":"Little Rock","state":"Arkansas","zip":"72223","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Pacific Clinical Research Medical Group","city":"Arcadia","state":"California","zip":"91007","country":"United States","geoPoint":{"lat":34.13973,"lon":-118.03534}},{"facility":"Southwestern Research, Incorporated","city":"Beverly Hills","state":"California","zip":"90210","country":"United States","geoPoint":{"lat":34.07362,"lon":-118.40036}},{"facility":"Clinical Innovations, Inc.","city":"Costa Mesa","state":"California","zip":"92626","country":"United States","geoPoint":{"lat":33.64113,"lon":-117.91867}},{"facility":"Synergy Clinical Research of Escondido","city":"Escondido","state":"California","zip":"92027","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Synergy Clinical Research Center","city":"National City","state":"California","zip":"91950","country":"United States","geoPoint":{"lat":32.67811,"lon":-117.0992}},{"facility":"Pacific Research Partners","city":"Oakland","state":"California","zip":"94612","country":"United States","geoPoint":{"lat":37.80437,"lon":-122.2708}},{"facility":"Pasadena Research Institute, LLC","city":"Pasadena","state":"California","zip":"91106","country":"United States","geoPoint":{"lat":34.14778,"lon":-118.14452}},{"facility":"Clinical Innovations, Inc.","city":"Riverside","state":"California","zip":"92506","country":"United States","geoPoint":{"lat":33.95335,"lon":-117.39616}},{"facility":"Affiliated Research Institute","city":"San Diego","state":"California","zip":"92108","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Clinical Innovations, Inc.","city":"San Diego","state":"California","zip":"92121","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"California Neuroscience Research Medical Group, Inc","city":"Sherman Oaks","state":"California","zip":"91403","country":"United States","geoPoint":{"lat":34.15112,"lon":-118.44925}},{"facility":"Viking Clinical Research Center","city":"Temecula","state":"California","zip":"92591","country":"United States","geoPoint":{"lat":33.49364,"lon":-117.14836}},{"facility":"Collaborative Neuroscience Network, Inc. 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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":"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":"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":"25375652","type":"DERIVED","citation":"Clayton AH, Tourian KA, Focht K, Hwang E, Cheng RF, Thase ME. Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial. J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061028&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained-Release%20%28DVS%20SR%29%20in%20Adult%20Outpatients%20with%20Major%20Depressive%20Disorder%20%28MDD%29"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Subjects were screened up to 2 weeks.","recruitmentDetails":"Subjects were recruited in the United States from October 2011 to May 2012.","groups":[{"id":"FG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"FG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"FG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"306"},{"groupId":"FG001","numSubjects":"306"},{"groupId":"FG002","numSubjects":"312"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"269"},{"groupId":"FG001","numSubjects":"258"},{"groupId":"FG002","numSubjects":"253"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"48"},{"groupId":"FG002","numSubjects":"59"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"20"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"9"}]},{"type":"Reasons not defined","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Did not take study drug","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The numbers are correct. Participants flow starts with all randomized subjects while baseline is summarized for safety population defined as randomized AND took at least one dose. Started- (Other Did not take study drug) is the number for baseline summary.","groups":[{"id":"BG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"BG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"BG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"300"},{"groupId":"BG001","value":"300"},{"groupId":"BG002","value":"309"},{"groupId":"BG003","value":"909"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.72","spread":"12.42"},{"groupId":"BG001","value":"41.78","spread":"13.56"},{"groupId":"BG002","value":"41.30","spread":"12.80"},{"groupId":"BG003","value":"41.60","spread":"12.92"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"173"},{"groupId":"BG001","value":"172"},{"groupId":"BG002","value":"165"},{"groupId":"BG003","value":"510"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"127"},{"groupId":"BG001","value":"128"},{"groupId":"BG002","value":"144"},{"groupId":"BG003","value":"399"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.","populationDescription":"Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"252"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.71","spread":"0.42"},{"groupId":"OG001","value":"-11.28","spread":"0.42"},{"groupId":"OG002","value":"-11.67","spread":"0.42"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.006","pValueComment":"A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"1.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.44","ciUpperLimit":"2.69"},{"groupIds":["OG000","OG002"],"groupDescription":"A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.001","pValueComment":"A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"1.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.84","ciUpperLimit":"3.08"}]},{"type":"PRIMARY","title":"Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline","populationDescription":"Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"301"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.50","spread":"0.44"},{"groupId":"OG001","value":"-10.86","spread":"0.43"},{"groupId":"OG002","value":"-11.16","spread":"0.43"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.014","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"1.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.28","ciUpperLimit":"2.45"},{"groupIds":["OG000","OG002"],"groupDescription":"To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"1.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.59","ciUpperLimit":"2.74"}]},{"type":"SECONDARY","title":"Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)","description":"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.","populationDescription":"Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"number of participants","timeFrame":"Baseline to Week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"301"}]}],"classes":[{"title":"1=Very much improved","categories":[{"measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"81"}]}]},{"title":"2=Much improved","categories":[{"measurements":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"104"},{"groupId":"OG002","value":"98"}]}]},{"title":"3=Minimally improved","categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"79"},{"groupId":"OG002","value":"69"}]}]},{"title":"4=No change","categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"49"}]}]},{"title":"5=Minimally worse","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"}]}]},{"title":"6=Much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"7=Very much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.029","pValueComment":"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of \"Row Mean Scores Differences\" controlling for site.","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"},{"groupIds":["OG000","OG002"],"groupDescription":"CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.001","pValueComment":"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of \"Row Mean Scores Differences\" controlling for site.","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)","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 = worse state.","populationDescription":"Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on scale","timeFrame":"Baseline to Week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"252"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.27","spread":"0.06"},{"groupId":"OG001","value":"-1.47","spread":"0.06"},{"groupId":"OG002","value":"-1.55","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.009","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.05","ciUpperLimit":"0.34"},{"groupIds":["OG000","OG002"],"groupDescription":"CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.001","statisticalMethod":"Mixed Models Analysis","paramType":"Adjusted Mean Difference","paramValue":"0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.13","ciUpperLimit":"0.43"}]},{"type":"SECONDARY","title":"Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score","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 = worse state.","populationDescription":"Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on scale","timeFrame":"Baseline to Week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"301"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.21","spread":"0.07"},{"groupId":"OG001","value":"-1.38","spread":"0.07"},{"groupId":"OG002","value":"-1.43","spread":"0.07"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.062","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"0.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"0.34"},{"groupIds":["OG000","OG002"],"groupDescription":"To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.014","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.04","ciUpperLimit":"0.39"}]},{"type":"SECONDARY","title":"Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.","populationDescription":"Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of the number of participants","timeFrame":"Baseline to Week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"301"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.46"},{"groupId":"OG001","value":"45.02"},{"groupId":"OG002","value":"47.51"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.198","statisticalMethod":"Regression, Logistic","paramType":"Adjusted Odds Ratio","paramValue":"1.242","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.893","ciUpperLimit":"1.726"},{"groupIds":["OG000","OG002"],"groupDescription":"Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.054","statisticalMethod":"Regression, Logistic","paramType":"Adjusted Odds Ratio","paramValue":"1.378","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.995","ciUpperLimit":"1.910"}]},{"type":"SECONDARY","title":"Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.","populationDescription":"Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of the number of participants","timeFrame":"Baseline to week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"294"},{"groupId":"OG001","value":"291"},{"groupId":"OG002","value":"301"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.77"},{"groupId":"OG001","value":"24.05"},{"groupId":"OG002","value":"28.57"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.615","statisticalMethod":"Regression, Logistic","paramType":"Adjusted Odds Ratio","paramValue":"1.105","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.749","ciUpperLimit":"1.631"},{"groupIds":["OG000","OG002"],"groupDescription":"Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.072","statisticalMethod":"Regression, Logistic","paramType":"Adjusted Odds Ratio","paramValue":"1.412","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.969","ciUpperLimit":"2.057"}]},{"type":"SECONDARY","title":"Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score","description":"The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.\n\nEach individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.","populationDescription":"Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 8 (final on-therapy)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper."},{"id":"OG001","title":"DVS SR 50 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper."},{"id":"OG002","title":"DVS SR 100 mg","description":"Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"149"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.45","spread":"0.36"},{"groupId":"OG001","value":"-0.35","spread":"0.35"},{"groupId":"OG002","value":"-0.13","spread":"0.33"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.837","pValueComment":"p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.98","ciUpperLimit":"0.80"},{"groupIds":["OG000","OG002"],"groupDescription":"The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.471","pValueComment":"p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline","statisticalMethod":"ANCOVA","paramType":"Adjusted Mean Difference","paramValue":"-0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.19","ciUpperLimit":"0.55"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","description":"The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. 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