{"protocolSection":{"identificationModule":{"nctId":"NCT00445679","orgStudyIdInfo":{"id":"3151A1-336"},"organization":{"fullName":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"briefTitle":"Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD","officialTitle":"A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-07"},"primaryCompletionDateStruct":{"date":"2009-02","type":"ACTUAL"},"completionDateStruct":{"date":"2009-02","type":"ACTUAL"},"studyFirstSubmitDate":"2007-03-06","studyFirstSubmitQcDate":"2007-03-08","studyFirstPostDateStruct":{"date":"2007-03-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-02-26","resultsFirstSubmitQcDate":"2013-10-08","resultsFirstPostDateStruct":{"date":"2013-11-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-10-08","lastUpdatePostDateStruct":{"date":"2013-11-04","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.","detailedDescription":"The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data."},"conditionsModule":{"conditions":["Depressive Disorder, Major"],"keywords":["major depressive disorder","MDD","depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":807,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"A","type":"EXPERIMENTAL","description":"DVS SR 50mg/day","interventionNames":["Drug: DVS SR"]},{"label":"B","type":"EXPERIMENTAL","description":"DVS SR 100mg/day","interventionNames":["Drug: DVS SR"]},{"label":"C","type":"EXPERIMENTAL","description":"DVS SR 200mg/day","interventionNames":["Drug: DVS SR"]},{"label":"D","type":"ACTIVE_COMPARATOR","description":"Paroxetine 20mg/day","interventionNames":["Drug: Paroxetine"]}],"interventions":[{"type":"DRUG","name":"DVS SR","description":"Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper","armGroupLabels":["A","B","C"]},{"type":"DRUG","name":"Paroxetine","description":"20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper","armGroupLabels":["D"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"Clinical Global Impressions Scale-Improvement (CGI-I) Scores","description":"CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).","timeFrame":"8 weeks"},{"measure":"Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores","description":"CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).","timeFrame":"8 weeks"},{"measure":"Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline","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":"Baseline and 8 weeks"},{"measure":"Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline","description":"The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.","timeFrame":"8 weeks"},{"measure":"Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline","description":"HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.","timeFrame":"8 weeks"},{"measure":"Covi Anxiety Scale Score Mean Change From Baseline","description":"Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.","timeFrame":"8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Primary Inclusion Criteria:\n\n1. Outpatient men and women at least 18 years of age.\n2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.\n3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.\n\nPrimary Exclusion Criteria:\n\n1. Treatment with DVS SR at any time in the past.\n2. Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.\n3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Medical Monitor","affiliation":"Wyeth is now a wholly owned subsidiary of Pfizer","role":"STUDY_DIRECTOR"},{"name":"Trial Manager","affiliation":"For China: medinfo@wyeth.com","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"city":"Beijing","zip":"100083","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"city":"Beijing","zip":"100088","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"city":"Guangdong Province","zip":"510370","country":"China"},{"city":"Hunan Province","zip":"410011","country":"China"},{"city":"Jiangsu Province","zip":"210029","country":"China"},{"city":"Shanghai","zip":"200030","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"city":"Shanghai","zip":"200065","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"city":"Shanxi Province","zip":"710032","country":"China"},{"city":"Sichuan Province","zip":"610041","country":"China"},{"city":"Yunnan Province","zip":"650032","country":"China"},{"city":"Zhejiang Province","zip":"310003","country":"China"},{"city":"Andhra Pradesh","zip":"500 038","country":"India"},{"city":"Andhra Pradesh","zip":"500034","country":"India"},{"city":"Andhra Pradesh","zip":"517 507","country":"India"},{"city":"Andhra Pradesh","zip":"530 002","country":"India"},{"city":"Chandigarh","zip":"160012","country":"India","geoPoint":{"lat":30.73629,"lon":76.7884}},{"city":"Gujarat","zip":"380006","country":"India"},{"city":"Gujarat","zip":"380013","country":"India"},{"city":"Karnataka","zip":"575 001","country":"India"},{"city":"Karnataka","zip":"575018","country":"India"},{"city":"Maharashtra","zip":"400 012","country":"India"},{"city":"Maharashtra","zip":"400 026","country":"India"},{"city":"Maharashtra","zip":"411001","country":"India"},{"city":"Mumbai Maharashtra","zip":"H19400 022","country":"India"},{"city":"New Delhi","zip":"110002","country":"India","geoPoint":{"lat":28.62137,"lon":77.2148}},{"city":"Punjab","zip":"141001","country":"India"},{"city":"Uttar Pradesh","zip":"226003","country":"India"},{"city":"Incheon","zip":"400-711","country":"South Korea","geoPoint":{"lat":37.45646,"lon":126.70515}},{"city":"Seoul","zip":"110-744","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Seoul","zip":"135-710","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Seoul","zip":"135-720","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Seoul","zip":"137-701","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Seoul","zip":"138-736","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Seoul","zip":"140-757","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Seoul","zip":"150-719","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Seoul","zip":"158-710","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Chang-hua","zip":"ROC 500","country":"Taiwan","geoPoint":{"lat":24.07327,"lon":120.56276}},{"city":"Kaohsiung City","zip":"ROC 80708","country":"Taiwan","geoPoint":{"lat":22.61626,"lon":120.31333}},{"city":"Taipei","zip":"ROC 100","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}},{"city":"Taipei","zip":"ROC 111","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}},{"city":"Taipei","zip":"ROC 112","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}},{"city":"Taipei","zip":"ROC 114","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}},{"city":"Taipei","zip":"ROC 220","country":"Taiwan","geoPoint":{"lat":25.05306,"lon":121.52639}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks.","recruitmentDetails":"Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008.","groups":[{"id":"FG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"FG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"FG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"FG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"203"},{"groupId":"FG001","numSubjects":"203"},{"groupId":"FG002","numSubjects":"205"},{"groupId":"FG003","numSubjects":"196"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"157"},{"groupId":"FG002","numSubjects":"139"},{"groupId":"FG003","numSubjects":"149"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"66"},{"groupId":"FG003","numSubjects":"47"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"30"},{"groupId":"FG003","numSubjects":"19"}]},{"type":"Failed to return","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"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"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"Compliance","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Withdrawal of Informed Consent","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"20"},{"groupId":"FG003","numSubjects":"18"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"BG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"BG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"BG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"203"},{"groupId":"BG001","value":"203"},{"groupId":"BG002","value":"205"},{"groupId":"BG003","value":"196"},{"groupId":"BG004","value":"807"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38.63","spread":"12.96"},{"groupId":"BG001","value":"39.26","spread":"13.22"},{"groupId":"BG002","value":"39.26","spread":"14.69"},{"groupId":"BG003","value":"38.27","spread":"13.22"},{"groupId":"BG004","value":"38.86","spread":"13.53"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"125"},{"groupId":"BG001","value":"129"},{"groupId":"BG002","value":"118"},{"groupId":"BG003","value":"117"},{"groupId":"BG004","value":"489"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"87"},{"groupId":"BG003","value":"79"},{"groupId":"BG004","value":"318"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.","populationDescription":"The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-02","paramType":"NUMBER","unitOfMeasure":"percentage of responders","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"OG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"OG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"OG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"200"},{"groupId":"OG002","value":"197"},{"groupId":"OG003","value":"192"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"63"},{"groupId":"OG003","value":"66"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.","paramType":"Difference","paramValue":"-3.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.62","ciUpperLimit":"6.37"},{"groupIds":["OG001","OG003"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.","paramType":"Difference","paramValue":"0.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.50","ciUpperLimit":"10.25"},{"groupIds":["OG002","OG003"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.","paramType":"Difference","paramValue":"-2.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.68","ciUpperLimit":"7.33"}]},{"type":"SECONDARY","title":"Clinical Global Impressions Scale-Improvement (CGI-I) Scores","description":"CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).","populationDescription":"The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-02","paramType":"NUMBER","unitOfMeasure":"subjects","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"OG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"OG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"OG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"200"},{"groupId":"OG002","value":"196"},{"groupId":"OG003","value":"191"}]}],"classes":[{"title":"Final - Score 1 (Very much improved)","categories":[{"measurements":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"79"},{"groupId":"OG003","value":"72"}]}]},{"title":"Final - Score 2 (Much improved)","categories":[{"measurements":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"59"}]}]},{"title":"Final - Score 3 (Minimally improved)","categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"37"}]}]},{"title":"Final - Score 4 (No change)","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"17"}]}]},{"title":"Final - Score 5 (Minimally worse)","categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"4"}]}]},{"title":"Final - Score 6 (Much worse)","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]},{"title":"Final - Score 7 (Very Much worse)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Final on-therapy population","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.714","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"},{"groupIds":["OG001","OG003"],"groupDescription":"Final on-therapy population","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.653","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"},{"groupIds":["OG002","OG003"],"groupDescription":"Final on-therapy population","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.881","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores","description":"CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).","populationDescription":"The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-02","paramType":"NUMBER","unitOfMeasure":"subjects","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"OG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"OG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"OG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"200"},{"groupId":"OG002","value":"197"},{"groupId":"OG003","value":"192"}]}],"classes":[{"title":"Final - Score 1 (Normal, not at all ill)","categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"53"},{"groupId":"OG003","value":"42"}]}]},{"title":"Final - Score 2 (Borderline mentally ill)","categories":[{"measurements":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"47"},{"groupId":"OG003","value":"49"}]}]},{"title":"Final - Score 3 (Mildly ill)","categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"51"}]}]},{"title":"Final - Score 4 (Moderately ill)","categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"38"},{"groupId":"OG003","value":"27"}]}]},{"title":"Final - Score 5 (Markedly ill)","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"15"}]}]},{"title":"Final - Score 6 (Severely ill)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"7"}]}]},{"title":"Final - Score 7 (Among the most extremely ill)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Final on-therapy population","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.450","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"},{"groupIds":["OG001","OG003"],"groupDescription":"Final on-therapy population","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.452","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"},{"groupIds":["OG002","OG003"],"groupDescription":"Final on-therapy population","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.850","statisticalMethod":"Cochran-Mantel-Haenszel","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline","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).","populationDescription":"The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-02","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 8 weeks","groups":[{"id":"OG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"OG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"OG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"OG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"193"},{"groupId":"OG001","value":"193"},{"groupId":"OG002","value":"192"},{"groupId":"OG003","value":"185"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-16.84","lowerLimit":"-18.37","upperLimit":"-15.31"},{"groupId":"OG001","value":"-17.84","lowerLimit":"-19.37","upperLimit":"-16.31"},{"groupId":"OG002","value":"-16.81","lowerLimit":"-18.43","upperLimit":"-15.20"},{"groupId":"OG003","value":"-16.54","lowerLimit":"-18.08","upperLimit":"-15.00"}]}]}]},{"type":"SECONDARY","title":"Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline","description":"The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.","populationDescription":"The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-02","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"scores on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"OG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"OG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"OG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"192"},{"groupId":"OG001","value":"192"},{"groupId":"OG002","value":"191"},{"groupId":"OG003","value":"185"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.69","lowerLimit":"-15.10","upperLimit":"-8.27"},{"groupId":"OG001","value":"-10.00","lowerLimit":"-13.75","upperLimit":"-6.26"},{"groupId":"OG002","value":"-9.10","lowerLimit":"-12.75","upperLimit":"-5.45"},{"groupId":"OG003","value":"-9.52","lowerLimit":"-12.40","upperLimit":"-6.63"}]}]}]},{"type":"SECONDARY","title":"Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline","description":"HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.","populationDescription":"The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-02","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"scores on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"OG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"OG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"OG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"200"},{"groupId":"OG002","value":"197"},{"groupId":"OG003","value":"192"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.50","lowerLimit":"-7.08","upperLimit":"-5.92"},{"groupId":"OG001","value":"-6.51","lowerLimit":"-7.06","upperLimit":"-5.95"},{"groupId":"OG002","value":"-6.42","lowerLimit":"-7.03","upperLimit":"-5.82"},{"groupId":"OG003","value":"-6.58","lowerLimit":"-7.15","upperLimit":"-6.01"}]}]}]},{"type":"SECONDARY","title":"Covi Anxiety Scale Score Mean Change From Baseline","description":"Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.","populationDescription":"The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.","reportingStatus":"POSTED","anticipatedPostingDate":"2010-02","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"scores on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day"},{"id":"OG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day"},{"id":"OG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day"},{"id":"OG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"193"},{"groupId":"OG001","value":"193"},{"groupId":"OG002","value":"192"},{"groupId":"OG003","value":"185"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.23","lowerLimit":"-1.47","upperLimit":"-0.99"},{"groupId":"OG001","value":"-1.28","lowerLimit":"-1.54","upperLimit":"-1.03"},{"groupId":"OG002","value":"-1.17","lowerLimit":"-1.44","upperLimit":"-0.89"},{"groupId":"OG003","value":"-1.24","lowerLimit":"-1.49","upperLimit":"-1.00"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"DVS SR 50","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day","seriousNumAffected":4,"seriousNumAtRisk":203,"otherNumAffected":128,"otherNumAtRisk":203},{"id":"EG001","title":"DVS SR 100","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day","seriousNumAffected":1,"seriousNumAtRisk":203,"otherNumAffected":128,"otherNumAtRisk":203},{"id":"EG002","title":"DVS SR 200","description":"Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day","seriousNumAffected":5,"seriousNumAtRisk":205,"otherNumAffected":140,"otherNumAtRisk":205},{"id":"EG003","title":"Paroxetine 20","description":"Paroxetine 20 mg/day","seriousNumAffected":2,"seriousNumAtRisk":196,"otherNumAffected":134,"otherNumAtRisk":196}],"seriousEvents":[{"term":"Cholelithiasis","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203},{"groupId":"EG001","numAffected":1,"numAtRisk":203},{"groupId":"EG002","numAffected":0,"numAtRisk":205},{"groupId":"EG003","numAffected":0,"numAtRisk":196}]},{"term":"Pituitary tumor benign","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":0,"numAtRisk":205},{"groupId":"EG003","numAffected":0,"numAtRisk":196}]},{"term":"Intentional overdose","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":1,"numAtRisk":205},{"groupId":"EG003","numAffected":0,"numAtRisk":196}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":2,"numAtRisk":205},{"groupId":"EG003","numAffected":1,"numAtRisk":196}]},{"term":"Mania","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":1,"numAtRisk":205},{"groupId":"EG003","numAffected":0,"numAtRisk":196}]},{"term":"Suicidal behavior","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":2,"numAtRisk":205},{"groupId":"EG003","numAffected":0,"numAtRisk":196}]},{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":0,"numAtRisk":205},{"groupId":"EG003","numAffected":2,"numAtRisk":196}]},{"term":"Drug abuse","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":0,"numAtRisk":205},{"groupId":"EG003","numAffected":1,"numAtRisk":196}]},{"term":"Major Depressive Disorder worsening","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":203},{"groupId":"EG001","numAffected":0,"numAtRisk":203},{"groupId":"EG002","numAffected":0,"numAtRisk":205},{"groupId":"EG003","numAffected":1,"numAtRisk":196}]}],"otherEvents":[{"term":"Palpitations","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":203},{"groupId":"EG001","numAffected":7,"numAtRisk":203},{"groupId":"EG002","numAffected":12,"numAtRisk":205},{"groupId":"EG003","numAffected":10,"numAtRisk":196}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":203},{"groupId":"EG001","numAffected":30,"numAtRisk":203},{"groupId":"EG002","numAffected":20,"numAtRisk":205},{"groupId":"EG003","numAffected":23,"numAtRisk":196}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":203},{"groupId":"EG001","numAffected":16,"numAtRisk":203},{"groupId":"EG002","numAffected":19,"numAtRisk":205},{"groupId":"EG003","numAffected":12,"numAtRisk":196}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":203},{"groupId":"EG001","numAffected":39,"numAtRisk":203},{"groupId":"EG002","numAffected":41,"numAtRisk":205},{"groupId":"EG003","numAffected":34,"numAtRisk":196}]},{"term":"Asthenia","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":203},{"groupId":"EG001","numAffected":5,"numAtRisk":203},{"groupId":"EG002","numAffected":11,"numAtRisk":205},{"groupId":"EG003","numAffected":6,"numAtRisk":196}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":203},{"groupId":"EG001","numAffected":8,"numAtRisk":203},{"groupId":"EG002","numAffected":11,"numAtRisk":205},{"groupId":"EG003","numAffected":13,"numAtRisk":196}]},{"term":"Anorexia","organSystem":"Metabolism and nutrition disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":203},{"groupId":"EG001","numAffected":14,"numAtRisk":203},{"groupId":"EG002","numAffected":12,"numAtRisk":205},{"groupId":"EG003","numAffected":14,"numAtRisk":196}]},{"term":"Dizziness","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":203},{"groupId":"EG001","numAffected":35,"numAtRisk":203},{"groupId":"EG002","numAffected":26,"numAtRisk":205},{"groupId":"EG003","numAffected":29,"numAtRisk":196}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":203},{"groupId":"EG001","numAffected":20,"numAtRisk":203},{"groupId":"EG002","numAffected":16,"numAtRisk":205},{"groupId":"EG003","numAffected":14,"numAtRisk":196}]},{"term":"Somnolence","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":203},{"groupId":"EG001","numAffected":17,"numAtRisk":203},{"groupId":"EG002","numAffected":11,"numAtRisk":205},{"groupId":"EG003","numAffected":20,"numAtRisk":196}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":203},{"groupId":"EG001","numAffected":14,"numAtRisk":203},{"groupId":"EG002","numAffected":19,"numAtRisk":205},{"groupId":"EG003","numAffected":8,"numAtRisk":196}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":203},{"groupId":"EG001","numAffected":8,"numAtRisk":203},{"groupId":"EG002","numAffected":6,"numAtRisk":205},{"groupId":"EG003","numAffected":6,"numAtRisk":196}]},{"term":"Sedation","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":203},{"groupId":"EG001","numAffected":5,"numAtRisk":203},{"groupId":"EG002","numAffected":9,"numAtRisk":205},{"groupId":"EG003","numAffected":10,"numAtRisk":196}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication."},"pointOfContact":{"title":"U. S. Contact Center","organization":"Wyeth","email":"clintrialresults@wyeth.com"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D017374","term":"Paroxetine"}],"ancestors":[{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}