{"protocolSection":{"identificationModule":{"nctId":"NCT00803361","orgStudyIdInfo":{"id":"11517"},"secondaryIdInfos":[{"id":"F1J-MC-HMFJ","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Duloxetine for the Treatment of Generalized Anxiety Disorder","officialTitle":"Duloxetine Versus Placebo in the Treatment of Patients With Generalized Anxiety Disorder in China"},"statusModule":{"statusVerifiedDate":"2010-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-12"},"primaryCompletionDateStruct":{"date":"2010-01","type":"ACTUAL"},"completionDateStruct":{"date":"2010-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-12-03","studyFirstSubmitQcDate":"2008-12-03","studyFirstPostDateStruct":{"date":"2008-12-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-11-19","resultsFirstSubmitQcDate":"2010-11-19","resultsFirstPostDateStruct":{"date":"2010-12-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2010-11-19","lastUpdatePostDateStruct":{"date":"2010-12-17","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Chief Medical Officer","oldOrganization":"Eli Lilly"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"},"collaborators":[{"name":"Boehringer Ingelheim","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder"},"conditionsModule":{"conditions":["Generalized Anxiety Disorder"],"keywords":["anxiety"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":210,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","interventionNames":["Drug: Duloxetine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"60 to 120 mg, capsules, oral, once a day for 15 weeks","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta","LY248686"]},{"type":"DRUG","name":"Placebo","description":"placebo capsules, oral, once a day for 15 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. 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Duloxetine versus placebo in the treatment of patients with generalized anxiety disorder in China. Chin Med J (Engl). 2011 Oct;124(20):3260-8."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Duloxetine","description":"60 to 120 mg, capsules, oral, once a day for 15 weeks"},{"id":"FG001","title":"Placebo","description":"placebo capsules, oral, once a day for 15 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"108"},{"groupId":"FG001","numSubjects":"102"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"82"},{"groupId":"FG001","numSubjects":"74"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"28"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"60 to 120 mg, capsules, oral, once a day for 15 weeks"},{"id":"BG001","title":"Placebo","description":"placebo capsules, oral, once a day for 15 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"108"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"210"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"37.26","spread":"11.85"},{"groupId":"BG001","value":"38.02","spread":"12.03"},{"groupId":"BG002","value":"37.63","spread":"11.92"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"106"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"104"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"108"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"210"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"108"},{"groupId":"BG001","value":"102"},{"groupId":"BG002","value":"210"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. 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