{"protocolSection":{"identificationModule":{"nctId":"NCT01571453","orgStudyIdInfo":{"id":"13926A"},"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries","officialTitle":"Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries"},"statusModule":{"statusVerifiedDate":"2014-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-05"},"primaryCompletionDateStruct":{"date":"2013-10","type":"ACTUAL"},"studyFirstSubmitDate":"2012-03-28","studyFirstSubmitQcDate":"2012-04-03","studyFirstPostDateStruct":{"date":"2012-04-05","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-06","resultsFirstSubmitQcDate":"2014-10-06","resultsFirstPostDateStruct":{"date":"2014-10-13","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-10-06","lastUpdatePostDateStruct":{"date":"2014-10-13","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day)."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["MDD"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":437,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine (Lu AA21004)","type":"EXPERIMENTAL","interventionNames":["Drug: Vortioxetine (Lu AA21004)"]},{"label":"Venlafaxine extended release","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Venlafaxine extended release"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine (Lu AA21004)","description":"10 mg/day","armGroupLabels":["Vortioxetine (Lu AA21004)"],"otherNames":["Brintellix"]},{"type":"DRUG","name":"Venlafaxine extended release","description":"150 mg/day","armGroupLabels":["Venlafaxine extended release"],"otherNames":["Efexor® XL"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in MADRS Total Score at Week 8","description":"Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.","timeFrame":"Baseline and Week 8"}],"secondaryOutcomes":[{"measure":"Change in CGI-S Score From Baseline to Week 8","description":"Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.","timeFrame":"Baseline and Week 8"},{"measure":"CGI-I Score at Week 8","description":"The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.","timeFrame":"Week 8"},{"measure":"Change in HAM-A Total Score From Baseline to Week 8","description":"Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.","timeFrame":"Baseline and Week 8"},{"measure":"MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)","timeFrame":"Week 8"},{"measure":"Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)","timeFrame":"Week 8"},{"measure":"Number of Adverse Events","timeFrame":"Baseline to Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)\n* The patient has a MADRS total score ≥26\n* The patient has a CGI-S score ≥4\n* The reported duration of the current MDE is ≥3 months.\n\nOther inclusion criteria may apply.\n\nExclusion Criteria:\n\n\\- The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.","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"}]},"referencesModule":{"references":[{"pmid":"31990207","type":"DERIVED","citation":"Wang G, Zhao K, Reynaud-Mougin C, Loft H, Ren H, Eriksen HF, Ettrup A. Successfully treated patients with vortioxetine versus venlafaxine: a simplified cost-effectiveness analysis based on a head-to-head study in Asian patients with major depressive disorder. Curr Med Res Opin. 2020 May;36(5):875-882. doi: 10.1080/03007995.2020.1723072. Epub 2020 Feb 13."},{"pmid":"25650503","type":"DERIVED","citation":"Wang G, Gislum M, Filippov G, Montgomery S. Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: a randomized, double-blind study. Curr Med Res Opin. 2015 Apr;31(4):785-94. doi: 10.1185/03007995.2015.1014028. Epub 2015 Feb 19."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A Screening Visit was held approximately 7 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria at the Screening and Baseline Visits and none of the exclusion criteria at the Screening and/or Baseline Visit were eligible to participate in this study.","recruitmentDetails":"In- or outpatients with a primary diagnosis of recurrent of Major Depressive Disorder (MDD) were recruited for this study from China, South Korea, Taiwan, and Thailand.","groups":[{"id":"FG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"FG001","title":"Venlafaxine","description":"Venlafaxine extended release 150 mg/day"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"211"},{"groupId":"FG001","numSubjects":"226"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"173"},{"groupId":"FG001","numSubjects":"164"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"62"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"32"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Non-compliance","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Withdrawal of consent","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Administrative or other reason(s)","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The all-patients-treated set (APTS) comprises all randomized patients who took at least one dose of IMP.\n\nBaseline age and gender is based on the APTS. Baseline efficacy outcome measures is based on the full-analysis set (FAS).","groups":[{"id":"BG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"BG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"211"},{"groupId":"BG001","value":"226"},{"groupId":"BG002","value":"437"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.6","spread":"12.4"},{"groupId":"BG001","value":"40.7","spread":"12.3"},{"groupId":"BG002","value":"40.1","spread":"12.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"123"},{"groupId":"BG001","value":"139"},{"groupId":"BG002","value":"262"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"175"}]}]}]},{"title":"MADRS total score","description":"Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges 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":"32.3","spread":"4.6"},{"groupId":"BG001","value":"32.3","spread":"4.5"},{"groupId":"BG002","value":"32.3","spread":"4.6"}]}]}]},{"title":"HAM-A total score","description":"Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Total score from 0 to 56; higher score indicates greater anxiety.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20.6","spread":"7.3"},{"groupId":"BG001","value":"21.1","spread":"7.0"},{"groupId":"BG002","value":"20.9","spread":"7.1"}]}]}]},{"title":"CGI-S score","description":"Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the patient is more ill.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.8","spread":"0.7"},{"groupId":"BG001","value":"4.9","spread":"0.7"},{"groupId":"BG002","value":"4.9","spread":"0.7"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in MADRS Total Score at Week 8","description":"Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.","populationDescription":"The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"OG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-19.36","spread":"0.70"},{"groupId":"OG001","value":"-18.16","spread":"0.68"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The sample size calculation was based on a non-inferiority comparison of the treatment groups in the change from baseline to Week 8 in MADRS total score using a two-sided 95% CI against a margin of +2.5 points. Assuming a standard deviation of 9.0 points and an expected true mean difference between treatments of 0 points, a total of 410 patients (205 per treatment group) were needed to provide a power of 80% for correctly concluding non-inferiority.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Vortioxetine was declared to be non-inferior to venlafaxine if the upper limit of the calculated two-sided 95% confidence interval for the treatment difference at Week 8 between vortioxetine and venlafaxine was less than +2.5 MADRS units versus venlafaxine.","pValue":"0.199","pValueComment":"No adjustments for multiple comparisons were made.","statisticalMethod":"ANCOVA","statisticalComment":"LOCF was used.","paramType":"Mean Difference (Final Values)","paramValue":"-1.20","ciPctValue":"95","ciLowerLimit":"-3.03","ciUpperLimit":"0.63","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.93"}]},{"type":"SECONDARY","title":"Change in CGI-S Score From Baseline to Week 8","description":"Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.","populationDescription":"The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"OG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.26","spread":"0.09"},{"groupId":"OG001","value":"-2.12","spread":"0.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The same ANCOVA methodology as for the primary endpoint was used.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.228","pValueComment":"No adjustments for multiple comparisons were made.","statisticalMethod":"ANCOVA","statisticalComment":"LOCF was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.39","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.12"}]},{"type":"SECONDARY","title":"CGI-I Score at Week 8","description":"The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.","populationDescription":"The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"OG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.99","spread":"0.08"},{"groupId":"OG001","value":"2.14","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The same ANCOVA methodology as for the primary endpoint was used.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.174","pValueComment":"No adjustments for multiple comparisons were made.","statisticalMethod":"ANCOVA","statisticalComment":"LOCF was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.35","ciUpperLimit":"0.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.11"}]},{"type":"SECONDARY","title":"Change in HAM-A Total Score From Baseline to Week 8","description":"Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.","populationDescription":"The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"OG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.38","spread":"0.48"},{"groupId":"OG001","value":"-10.56","spread":"0.47"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The same ANCOVA methodology as for the primary endpoint was used.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.207","pValueComment":"No adjustments for multiple comparisons were made.","statisticalMethod":"ANCOVA","statisticalComment":"LOCF was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.82","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.09","ciUpperLimit":"0.45","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.65"}]},{"type":"SECONDARY","title":"MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)","populationDescription":"The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"OG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"66.5"},{"groupId":"OG001","value":"61.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.272","pValueComment":"Wald's Test. No adjustments for multiple comparisons were made.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.25","ciPctValue":"95","ciLowerLimit":"0.84","ciUpperLimit":"1.86"}]},{"type":"SECONDARY","title":"Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)","populationDescription":"The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day"},{"id":"OG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"},{"groupId":"OG001","value":"215"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"43.1"},{"groupId":"OG001","value":"41.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.731","pValueComment":"Wald's Test. No adjustments for multiple comparisons were made.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.07","ciPctValue":"95","ciLowerLimit":"0.73","ciUpperLimit":"1.58"}]},{"type":"SECONDARY","title":"Number of Adverse Events","timeFrame":"Baseline to Week 12"}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline to 12 weeks","eventGroups":[{"id":"EG000","title":"Vortioxetine","description":"Vortioxetine (Lu AA21004): 10 mg/day","seriousNumAffected":2,"seriousNumAtRisk":211,"otherNumAffected":90,"otherNumAtRisk":211},{"id":"EG001","title":"Venlafaxine","description":"Venlafaxine extended release: 150 mg/day","seriousNumAffected":8,"seriousNumAtRisk":226,"otherNumAffected":124,"otherNumAtRisk":226}],"seriousEvents":[{"term":"Vertigo positional","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":211},{"groupId":"EG001","numAffected":1,"numAtRisk":226}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":211},{"groupId":"EG001","numAffected":1,"numAtRisk":226}]},{"term":"Intentional overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":211},{"groupId":"EG001","numAffected":1,"numAtRisk":226}]},{"term":"Ligament sprain","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":211},{"groupId":"EG001","numAffected":1,"numAtRisk":226}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":211},{"groupId":"EG001","numAffected":1,"numAtRisk":226}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":211},{"groupId":"EG001","numAffected":0,"numAtRisk":226}]},{"term":"Major depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":211},{"groupId":"EG001","numAffected":1,"numAtRisk":226}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":211},{"groupId":"EG001","numAffected":2,"numAtRisk":226}]},{"term":"Varicocele","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":211},{"groupId":"EG001","numAffected":1,"numAtRisk":226}]}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":211},{"groupId":"EG001","numAffected":18,"numAtRisk":226}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":211},{"groupId":"EG001","numAffected":24,"numAtRisk":226}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":211},{"groupId":"EG001","numAffected":9,"numAtRisk":226}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":211},{"groupId":"EG001","numAffected":53,"numAtRisk":226}]},{"term":"Accidental overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":211},{"groupId":"EG001","numAffected":12,"numAtRisk":226}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":211},{"groupId":"EG001","numAffected":23,"numAtRisk":226}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":211},{"groupId":"EG001","numAffected":32,"numAtRisk":226}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":211},{"groupId":"EG001","numAffected":16,"numAtRisk":226}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":211},{"groupId":"EG001","numAffected":17,"numAtRisk":226}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Email contact via H. 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