{"protocolSection":{"identificationModule":{"nctId":"NCT00401726","orgStudyIdInfo":{"id":"0600B1-416"},"organization":{"fullName":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"briefTitle":"Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program","officialTitle":"Patient Outcomes With Education, Drug Therapy, and Support (POETS): A Multicenter, Open-label, Randomized Study to Evaluate Depressed Subjects Treated With Venlafaxine Extended-release vs. Venlafaxine Extended-release Plus the Dialogues Time to Talk Program in a Primary Care Setting"},"statusModule":{"statusVerifiedDate":"2012-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-06"},"completionDateStruct":{"date":"2007-10","type":"ACTUAL"},"studyFirstSubmitDate":"2006-11-17","studyFirstSubmitQcDate":"2006-11-17","studyFirstPostDateStruct":{"date":"2006-11-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-03-31","resultsFirstSubmitQcDate":"2010-05-26","resultsFirstPostDateStruct":{"date":"2010-06-29","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-04-19","lastUpdatePostDateStruct":{"date":"2012-04-23","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"leadSponsor":{"name":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). 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There was not a screening period.","recruitmentDetails":"Subjects were recruited in the United States from June 2006 to March 2007.","groups":[{"id":"FG000","title":"Venlafaxine Extended Release (ER)","description":"75-225 mg per day"},{"id":"FG001","title":"Venlafaxine Extended Release (ER) Plus Dialogues","description":"Venlafaxine ER 75-225 mg per day plus \"Dialogues Time to Talk\" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"269"},{"groupId":"FG001","numSubjects":"268"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"172"},{"groupId":"FG001","numSubjects":"156"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"112"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"45"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Sponsor Request","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Venlafaxine Extended Release (ER)","description":"75-225 mg per day"},{"id":"BG001","title":"Venlafaxine Extended Release (ER) Plus Dialogues","description":"Venlafaxine ER 75-225 mg per day plus \"Dialogues Time to Talk\" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.13","spread":"13.59"},{"groupId":"BG001","value":"45.25","spread":"13.83"},{"groupId":"BG002","value":"44.69","spread":"13.71"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"199"},{"groupId":"BG001","value":"190"},{"groupId":"BG002","value":"389"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"148"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Patients Responding \"Very Satisfied\" on Satisfaction With Depression Care Scale (SDCS)","description":"Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). \"Very satisfied\" was defined as a score of greater than or equal to 8.","populationDescription":"The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-03","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"112 days","groups":[{"id":"OG000","title":"Venlafaxine Extended Release (ER)","description":"75-225 mg per day"},{"id":"OG001","title":"Venlafaxine Extended Release (ER) Plus Dialogues","description":"Venlafaxine ER 75-225 mg per day plus \"Dialogues Time to Talk\" program (Dialogues). 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