{"protocolSection":{"identificationModule":{"nctId":"NCT00761306","orgStudyIdInfo":{"id":"11492C"},"secondaryIdInfos":[{"id":"2007-000905-31","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults","officialTitle":"A Long-term, Open-label Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-06"},"primaryCompletionDateStruct":{"date":"2008-09","type":"ACTUAL"},"completionDateStruct":{"date":"2008-10","type":"ACTUAL"},"studyFirstSubmitDate":"2008-09-26","studyFirstSubmitQcDate":"2008-09-26","studyFirstPostDateStruct":{"date":"2008-09-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-28","resultsFirstSubmitQcDate":"2013-10-28","resultsFirstPostDateStruct":{"date":"2013-12-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-12-23","lastUpdatePostDateStruct":{"date":"2014-01-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder","Long-term","Safety","Open-label"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":74,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine","type":"EXPERIMENTAL","interventionNames":["Drug: Vortioxetine (Lu AA21004)"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine (Lu AA21004)","description":"5 or 10 mg/day; tablets; orally","armGroupLabels":["Vortioxetine"],"otherNames":["Brintellix"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Patients With Adverse Events (AEs)","timeFrame":"Up to 52 weeks and a 4-week safety follow-up period"},{"measure":"Percentage of Patients Who Withdrew Due to Intolerance to Treatment","timeFrame":"Baseline to Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in MADRS Total Score After 52 Weeks of Treatment","description":"The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment","description":"The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.","timeFrame":"Baseline and Week 52"},{"measure":"Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)","timeFrame":"Week 52"},{"measure":"Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)","timeFrame":"Week 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n\\- Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period\n\nExclusion Criteria:\n\n* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR)\n* Female patients of childbearing potential who are not using effective contraception\n* Use of any psychoactive medication\n\nOther protocol-defined inclusion and exclusion criteria may apply.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Email contact via H. Lundbeck A/S","affiliation":"LundbeckClinicalTrials@lundbeck.com","role":"STUDY_DIRECTOR"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study consisted of a 1-week, fixed-dose period with Vortioxetine 10 mg/day, a 51-week flexible dose period with Vortioxetine 5 or 10 mg/day, and a 4-week safety follow up period.","recruitmentDetails":"Patients eligible to participate in present study, NCT00761306 / 11492C, were outpatients, who had completed lead-in study NCT00839423 / 11492A immediately prior to inclusion into present study.","groups":[{"id":"FG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"74"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"54"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Administrative or Other Reasons","reasons":[{"groupId":"FG000","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Age and Sex: all-patients-treated set (APTS) - all patients who took at least one dose of Vortioxetine in Study NCT00761306 / 11492C; MADRS and HAM-D-24: full-analysis set (FAS) = 74 - all patients in the APTS who had at least one valid Baseline and one valid post-Baseline assessment of the MADRS total score in Study NCT00761306 / 11492C.","groups":[{"id":"BG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"74"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.5","spread":"11.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"45"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"29"}]}]}]},{"title":"MADRS","description":"The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10.7","spread":"8.4"}]}]}]},{"title":"HAM-D-24","description":"The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10.2","spread":"7.8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Patients With Adverse Events (AEs)","populationDescription":"APTS","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Up to 52 weeks and a 4-week safety follow-up period","groups":[{"id":"OG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"}]}],"classes":[{"title":"Patients With AEs","categories":[{"measurements":[{"groupId":"OG000","value":"64"}]}]},{"title":"Patients With SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Patients With AEs Leading to Withdrawal","categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]},{"title":"Patients With Baseline Events","categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}]}]},{"type":"PRIMARY","title":"Percentage of Patients Who Withdrew Due to Intolerance to Treatment","populationDescription":"APTS","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Baseline to Week 52","groups":[{"id":"OG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.8"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in MADRS Total Score After 52 Weeks of Treatment","description":"The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.","populationDescription":"FAS; observed cases (OC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.33","spread":"9.24"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment","description":"The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.","populationDescription":"FAS; OC","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"59"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.46","spread":"8.72"}]}]}]},{"type":"SECONDARY","title":"Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)","populationDescription":"FAS; OC","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"92.7"}]}]}]},{"type":"SECONDARY","title":"Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)","populationDescription":"FAS; OC","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Vortioxetine 5 or 10 mg/Day","description":"tablets; orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"81.8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period","eventGroups":[{"id":"EG000","title":"Vortioxetine 5 or 10 mg/Day","seriousNumAffected":1,"seriousNumAtRisk":74,"otherNumAffected":53,"otherNumAtRisk":74}],"seriousEvents":[{"term":"Thyroiditis","organSystem":"Endocrine disorders","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74}]}],"otherEvents":[{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":74}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":74}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":74}]},{"term":"Weight increased","organSystem":"Investigations","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":74}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":74}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MEDDRA11_0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"The main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship."},"pointOfContact":{"title":"H. Lundbeck A/S","organization":"H. Lundbeck A/S","email":"LundbeckClinicalTrials@lundbeck.com","phone":"+45 3630 1311"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078784","term":"Vortioxetine"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}