{"protocolSection":{"identificationModule":{"nctId":"NCT01056289","orgStudyIdInfo":{"id":"3151A1-4437"},"secondaryIdInfos":[{"id":"B2061010"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)","officialTitle":"A Randomized, Double-Blind, Parallel Group Study To Compare Discontinuation Symptoms In Abrupt Discontinuation Versus A 1-Week Tapering Regimen In Subjects With MDD Treated For 24 Weeks With Open-Label 50 mg DVS SR Formulation"},"statusModule":{"statusVerifiedDate":"2011-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-03"},"primaryCompletionDateStruct":{"date":"2011-02","type":"ACTUAL"},"completionDateStruct":{"date":"2011-02","type":"ACTUAL"},"studyFirstSubmitDate":"2010-01-22","studyFirstSubmitQcDate":"2010-01-22","studyFirstPostDateStruct":{"date":"2010-01-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-01-31","resultsFirstSubmitQcDate":"2012-01-31","resultsFirstPostDateStruct":{"date":"2012-02-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-02-25","lastUpdatePostDateStruct":{"date":"2012-02-28","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)"},"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":480,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Desvenlafaxine Succinate Sustained-Release Formulation 50 mg","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg"]},{"label":"Desvenlafaxine Succinate Sustained-Release Formulation 25 mg","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained-Release Formulation 50 mg","description":"DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.","armGroupLabels":["Desvenlafaxine Succinate Sustained-Release Formulation 50 mg"]},{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained-Release Formulation 25 mg","description":"DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.","armGroupLabels":["Desvenlafaxine Succinate Sustained-Release Formulation 25 mg"]},{"type":"DRUG","name":"Placebo","description":"DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase","description":"Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2\\*mean(of DESSDB Week 1, DESSDB Week 2).","timeFrame":"Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase","description":"Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.","timeFrame":"Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)"},{"measure":"Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms","description":"Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.","timeFrame":"Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Primary Diagnosis of Major Depressive Disorder\n* Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline\n\nExclusion Criteria:\n\n* Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder\n* Potentially violent to others or is at significant risk for suicide\n* History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion\n* Known presence of raised intraocular pressure or history of narrow angle glaucoma","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}]},"referencesModule":{"references":[{"pmid":"26137358","type":"DERIVED","citation":"Ninan PT, Musgnung J, Messig M, Buckley G, Guico-Pabia CJ, Ramey TS. Incidence and Timing of Taper/Posttherapy-Emergent Adverse Events Following Discontinuation of Desvenlafaxine 50 mg/d in Patients With Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 5;17(1):10.4088/PCC.14m01715. doi: 10.4088/PCC.14m01715. eCollection 2015."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-4437&StudyName=Study%20Comparing%20Discontinuation%20Symptoms%20Of%20DVS%20SR%20In%20Subjects%20With%20Major%20Depressive%20Disorder%20%28MDD%29"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Eligible participants entered a 24 Week Open-label treatment phase; participants who completed the Open-label phase were randomized to a 4 Week Double-blind treatment phase.","groups":[{"id":"FG000","title":"DVS SR 50 mg (Open-label Phase)","description":"Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks."},{"id":"FG001","title":"DVS SR 50 mg (Double-blind Phase)","description":"DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4."},{"id":"FG002","title":"DVS SR 25 mg (Double-blind Phase)","description":"DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4."},{"id":"FG003","title":"Placebo (Double-blind Phase)","description":"Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4."}],"periods":[{"title":"Open-label Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"480"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Participants transitioned to Double-blind phase","numSubjects":"361"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"119"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Not randomized to Double-blind phase","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Double-blind Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"73"},{"groupId":"FG002","numSubjects":"140"},{"groupId":"FG003","numSubjects":"148"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"127"},{"groupId":"FG003","numSubjects":"138"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"13"},{"groupId":"FG003","numSubjects":"10"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Discontinuation symptom","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Entire Study Population","description":"24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"480"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.5","spread":"13.0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"330"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"150"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase","description":"Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2\\*mean(of DESSDB Week 1, DESSDB Week 2).","populationDescription":"Full Analysis Set (FAS): all randomized participants who had at least 1 postrandomization DESS record. Mean was adjusted for baseline DESS score and study center.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)","groups":[{"id":"OG000","title":"DVS SR 50 mg","description":"DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4."},{"id":"OG001","title":"DVS SR 25 mg","description":"DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4."},{"id":"OG002","title":"Placebo","description":"Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"146"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.1","spread":"0.72"},{"groupId":"OG001","value":"4.8","spread":"0.54"},{"groupId":"OG002","value":"5.3","spread":"0.52"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Difference: Placebo versus DVS SR 50 mg","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \\>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"1.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"2.83"},{"groupIds":["OG000","OG001"],"groupDescription":"Difference: DVS SR 25 mg versus DVS SR 50 mg","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \\>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.03","ciUpperLimit":"2.35"},{"groupIds":["OG001","OG002"],"groupDescription":"Difference: Placebo versus DVS SR 25 mg","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \\>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"0.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.88","ciUpperLimit":"1.89"}]},{"type":"SECONDARY","title":"Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase","description":"Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. 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However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.","eventGroups":[{"id":"EG000","title":"DVS SR 50 mg (Open-label Phase)","description":"DVS SR 50 mg PO QD for 24 Weeks.","seriousNumAffected":5,"seriousNumAtRisk":480,"otherNumAffected":197,"otherNumAtRisk":480},{"id":"EG001","title":"DVS SR 50 mg (Double-blind Phase)","description":"DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.","seriousNumAffected":0,"seriousNumAtRisk":73,"otherNumAffected":9,"otherNumAtRisk":73},{"id":"EG002","title":"DVS SR 25 mg (Double-blind Phase)","description":"DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 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