{"protocolSection":{"identificationModule":{"nctId":"NCT01121484","orgStudyIdInfo":{"id":"3151A1-3364"},"secondaryIdInfos":[{"id":"B2061029"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)","officialTitle":"A Multicenter, Parallel-Group, Randomized, 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of 50 mg Of DVS SR In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2012-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-06"},"primaryCompletionDateStruct":{"date":"2011-06","type":"ACTUAL"},"completionDateStruct":{"date":"2011-06","type":"ACTUAL"},"studyFirstSubmitDate":"2010-05-03","studyFirstSubmitQcDate":"2010-05-10","studyFirstPostDateStruct":{"date":"2010-05-12","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-02-16","resultsFirstSubmitQcDate":"2012-03-02","resultsFirstPostDateStruct":{"date":"2012-03-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-03-30","lastUpdatePostDateStruct":{"date":"2012-04-04","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women 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":439,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"desvenlafaxine succinate sustained-release","type":"EXPERIMENTAL","interventionNames":["Drug: desvenlafaxine succinate sustained-release"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"desvenlafaxine succinate sustained-release","description":"50-mg DVS SR tablets taken orally once daily.","armGroupLabels":["desvenlafaxine succinate sustained-release"],"otherNames":["Pristiq"]},{"type":"DRUG","name":"placebo","description":"Placebo tablets taken orally once daily.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8","description":"HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \\& weight loss). 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Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.\n* Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of \\>=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).\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* Known presence of raised intraocular pressure or history of narrow-angle glaucoma.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"40 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call 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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":"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":"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":"25860107","type":"DERIVED","citation":"Kornstein SG, Clayton AH, Bao W, Guico-Pabia CJ. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. J Womens Health (Larchmt). 2015 Apr;24(4):281-90. doi: 10.1089/jwh.2014.4900."},{"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":"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."},{"pmid":"24229754","type":"DERIVED","citation":"Clayton AH, Kornstein SG, Dunlop BW, Focht K, Musgnung J, Ramey T, Bao W, Ninan PT. Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. J Clin Psychiatry. 2013 Oct;74(10):1010-7. doi: 10.4088/JCP.12m08065."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3364&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained-Release%20%28DVS%20SR%29%20In%20The%20Treatment%20Of%20Peri-%20And%20Postmenopausal%20Women%20With%20Major%20De"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Desvenlafaxine Succinate","description":"Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks"},{"id":"FG001","title":"Placebo","description":"Matching placebo tablets once daily for 10 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"218"},{"groupId":"FG001","numSubjects":"221"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"217"},{"groupId":"FG001","numSubjects":"217"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"185"},{"groupId":"FG001","numSubjects":"178"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"43"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"11"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Discontinuation of study by sponsor","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Randomized, not treated","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Desvenlafaxine Succinate","description":"Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks"},{"id":"BG001","title":"Placebo","description":"Matching placebo tablets once daily for 10 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"217"},{"groupId":"BG001","value":"217"},{"groupId":"BG002","value":"434"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.1","spread":"6.85"},{"groupId":"BG001","value":"52.8","spread":"6.58"},{"groupId":"BG002","value":"53.0","spread":"6.71"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"217"},{"groupId":"BG001","value":"217"},{"groupId":"BG002","value":"434"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8","description":"HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \\& weight loss). 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Last Observation Carried Forward (LOCF).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate","description":"Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets once daily for 10 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"216"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"22.8","spread":"3.29"},{"groupId":"OG001","value":"22.4","spread":"3.51"}]}]},{"title":"Change at Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-9.7","spread":"6.54"},{"groupId":"OG001","value":"-7.4","spread":"6.74"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Null hypothesis: no difference between treatment groups","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","pValueComment":"Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.","statisticalMethod":"ANCOVA","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)","description":"CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","populationDescription":"FAS; LOCF","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Desvenlafaxine Succinate","description":"Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks"},{"id":"OG001","title":"Placebo","description":"Matching placebo tablets once daily for 10 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"216"},{"groupId":"OG001","value":"216"}]}],"classes":[{"title":"Very Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"39"}]}]},{"title":"Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"37"}]}]},{"title":"Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"62"}]}]},{"title":"No Change","categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"69"}]}]},{"title":"Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}]}]},{"title":"Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}]},{"title":"Very Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.","statisticalMethod":"Cochran-Mantel-Haenszel","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8","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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