{"protocolSection":{"identificationModule":{"nctId":"NCT01140906","orgStudyIdInfo":{"id":"13267A"},"secondaryIdInfos":[{"id":"2009-017523-26","type":"EUDRACT_NUMBER"},{"id":"2009","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2009"}],"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults","officialTitle":"A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-05"},"primaryCompletionDateStruct":{"date":"2011-09","type":"ACTUAL"},"studyFirstSubmitDate":"2010-06-09","studyFirstSubmitQcDate":"2010-06-09","studyFirstPostDateStruct":{"date":"2010-06-10","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-28","resultsFirstSubmitQcDate":"2013-12-23","resultsFirstPostDateStruct":{"date":"2014-02-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-12-23","lastUpdatePostDateStruct":{"date":"2014-02-11","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 the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major depressive disorder","Placebo-controlled","Active reference","Multicenter study","Randomised study","Acute treatment"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":607,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Vortioxetine: 15 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Vortioxetine (Lu AA21004)"]},{"label":"Vortioxetine: 20 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Vortioxetine (Lu AA21004)"]},{"label":"Duloxetine: 60 mg","type":"OTHER","description":"Active Reference","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"capsules, daily, orally","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Vortioxetine (Lu AA21004)","description":"encapsulated tablets, daily, orally","armGroupLabels":["Vortioxetine: 15 mg","Vortioxetine: 20 mg"],"otherNames":["Brintellix"]},{"type":"DRUG","name":"Duloxetine","description":"encapsulated capsules, daily, orally","armGroupLabels":["Duloxetine: 60 mg"],"otherNames":["Cymbalta®"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in MADRS Total Score After 8 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 8"}],"secondaryOutcomes":[{"measure":"Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)","timeFrame":"Week 8"},{"measure":"Change in Clinical Status Using CGI-I Score at Week 8","description":"The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.","timeFrame":"Week 8"},{"measure":"Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20","timeFrame":"Baseline and Week 8"},{"measure":"Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)","timeFrame":"Week 8"},{"measure":"Change From Baseline in SDS Total Score After 8 Weeks of Treatment","description":"The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.","timeFrame":"Baseline and Week 8"},{"measure":"Change From Baseline in ASEX Total Score After 8 Weeks of Treatment","description":"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, \"How strong is your sex drive?\", \"Are your orgasms satisfying?\") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.","timeFrame":"Baseline and Week 8"},{"measure":"Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine","description":"The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms.","timeFrame":"Change from Week 8 in DESS total score analyzed at Week 10"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)\n* The patient has a MADRS total score \\>=26\n* The patient has a CGI-S score \\>=4\n* The patient has had the current episode of MDE for \\>3 months\n\nExclusion Criteria:\n\n* Any current anxiety psychiatric disorder as defined in the DSM-IV TR\n* Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR\n* Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR\n* Use of any psychoactive medication 2 weeks prior to screening and during the study\n* The patient is at significant risk of suicide or has a score \\>=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit\n\nOther protocol-defined inclusion and exclusion criteria may apply.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 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":"36708956","type":"DERIVED","citation":"Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26."},{"pmid":"32242018","type":"DERIVED","citation":"Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5."},{"pmid":"31818787","type":"DERIVED","citation":"Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13."},{"pmid":"31087825","type":"DERIVED","citation":"Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556."},{"pmid":"27780334","type":"DERIVED","citation":"McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744."},{"pmid":"24257717","type":"DERIVED","citation":"Boulenger JP, Loft H, Olsen CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psychopharmacol. 2014 May;29(3):138-49. doi: 10.1097/YIC.0000000000000018."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"At the Baseline Visit, patients who fulfilled the selection criteria were assigned to treatment with either placebo, vortioxetine 15 or 20 mg/day, or duloxetine 60 mg/day in a 1:1:1:1 ratio.","recruitmentDetails":"Patients were selected from psychiatric settings (private practices), outpatient clinics, and inpatient hospitals.","groups":[{"id":"FG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"FG001","title":"Vortioxetine 15 mg","description":"encapsulated tablets, daily, orally"},{"id":"FG002","title":"Vortioxetine 20 mg","description":"encapsulated tablets, daily, orally"},{"id":"FG003","title":"Duloxetine 60 mg","description":"encapsulated capsules, daily, orally"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"158"},{"groupId":"FG001","numSubjects":"151"},{"groupId":"FG002","numSubjects":"151"},{"groupId":"FG003","numSubjects":"147"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"117"},{"groupId":"FG002","numSubjects":"125"},{"groupId":"FG003","numSubjects":"131"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"17"},{"groupId":"FG003","numSubjects":"7"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Non-compliance","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal of consent","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Administrative or other reason","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"BG001","title":"Vortioxetine 15 mg","description":"encapsulated tablets, daily, orally"},{"id":"BG002","title":"Vortioxetine 20 mg","description":"encapsulated tablets, daily, orally"},{"id":"BG003","title":"Duloxetine 60 mg","description":"encapsulated capsules, daily, orally"},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"158"},{"groupId":"BG001","value":"151"},{"groupId":"BG002","value":"151"},{"groupId":"BG003","value":"147"},{"groupId":"BG004","value":"607"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.1","spread":"13.1"},{"groupId":"BG001","value":"47.0","spread":"14.6"},{"groupId":"BG002","value":"46.2","spread":"13.4"},{"groupId":"BG003","value":"45.6","spread":"13.6"},{"groupId":"BG004","value":"46.7","spread":"13.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"110"},{"groupId":"BG001","value":"97"},{"groupId":"BG002","value":"91"},{"groupId":"BG003","value":"102"},{"groupId":"BG004","value":"400"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"45"},{"groupId":"BG004","value":"207"}]}]}]},{"title":"MADRS baseline total score","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. 9 of the items are based on patient report, and 1 is based on the rater's observation of the patients. 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":"31.5","spread":"3.6"},{"groupId":"BG001","value":"31.8","spread":"3.4"},{"groupId":"BG002","value":"31.2","spread":"3.4"},{"groupId":"BG003","value":"31.2","spread":"3.5"},{"groupId":"BG004","value":"31.4","spread":"3.5"}]}]}]},{"title":"CGI-S baseline severity score","description":"The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.9","spread":"0.7"},{"groupId":"BG001","value":"4.9","spread":"0.6"},{"groupId":"BG002","value":"4.8","spread":"0.7"},{"groupId":"BG003","value":"4.8","spread":"0.7"},{"groupId":"BG004","value":"4.8","spread":"0.7"}]}]}]},{"title":"HAM-A baseline total score","description":"The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20.8","spread":"6.6"},{"groupId":"BG001","value":"21.3","spread":"6.8"},{"groupId":"BG002","value":"20.4","spread":"6.9"},{"groupId":"BG003","value":"20.5","spread":"6.7"},{"groupId":"BG004","value":"20.8","spread":"6.7"}]}]}]},{"title":"SDS total baseline score","description":"The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19.8","spread":"6.0"},{"groupId":"BG001","value":"20.6","spread":"5.3"},{"groupId":"BG002","value":"20.7","spread":"4.8"},{"groupId":"BG003","value":"20.5","spread":"4.4"},{"groupId":"BG004","value":"20.4","spread":"5.2"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in MADRS Total Score After 8 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":"Full-analysis set (FAS), mixed model for repeated measurements (MMRM)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"OG001","title":"Vortioxetine 15 mg","description":"encapsulated tablets, daily, orally"},{"id":"OG002","title":"Vortioxetine 20 mg","description":"encapsulated tablets, daily, orally"},{"id":"OG003","title":"Duloxetine 60 mg","description":"encapsulated capsules, daily, orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"151"},{"groupId":"OG003","value":"146"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.70","spread":"0.76"},{"groupId":"OG001","value":"-17.23","spread":"0.79"},{"groupId":"OG002","value":"-18.79","spread":"0.78"},{"groupId":"OG003","value":"-21.15","spread":"0.77"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Since p-value \\<0.025, hierarchically testing continued.","statisticalMethod":"MMRM","paramType":"Mean Difference (Final Values)","paramValue":"-5.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.66","ciUpperLimit":"-3.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.09","estimateComment":"To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025."},{"groupIds":["OG000","OG002"],"groupDescription":"As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Since p-value \\<0.025, hierarchically testing continued.","statisticalMethod":"MMRM","paramType":"Mean Difference (Final Values)","paramValue":"-7.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.21","ciUpperLimit":"-4.97","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.08","estimateComment":"To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025."},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"This treatment arm was not in the testing sequence. A nominal p-value is provided.","statisticalMethod":"MMRM","paramType":"Mean Difference (Final Values)","paramValue":"-9.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.55","ciUpperLimit":"-7.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.07"}]},{"type":"SECONDARY","title":"Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)","populationDescription":"FAS, last observation carried forward (LOCF), Logistic Regression","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"OG001","title":"Vortioxetine 15 mg","description":"encapsulated tablets, daily, orally"},{"id":"OG002","title":"Vortioxetine 20 mg","description":"encapsulated tablets, daily, orally"},{"id":"OG003","title":"Duloxetine 60 mg","description":"encapsulated capsules, daily, orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"151"},{"groupId":"OG003","value":"146"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"74"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Wald's test. Since p-value \\<0.025, hierarchically testing continued.","statisticalMethod":"Adjusted Odds Ratio","paramType":"Odds Ratio (OR)","paramValue":"2.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.76","ciUpperLimit":"4.47","estimateComment":"To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025."},{"groupIds":["OG000","OG002"],"groupDescription":"As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Wald's test. Since p-value \\<0.025, hierarchically testing continued.","statisticalMethod":"Adjusted Odds Ratio","paramType":"Odds Ratio (OR)","paramValue":"3.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.10","ciUpperLimit":"5.36","estimateComment":"To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025."},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"This treatment arm was not in the testing sequence. 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The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.","populationDescription":"FAS, MMRM","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"OG001","title":"Vortioxetine 15 mg","description":"encapsulated tablets, daily, orally"},{"id":"OG002","title":"Vortioxetine 20 mg","description":"encapsulated tablets, daily, orally"},{"id":"OG003","title":"Duloxetine 60 mg","description":"encapsulated capsules, daily, orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"151"},{"groupId":"OG003","value":"146"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.86","spread":"0.09"},{"groupId":"OG001","value":"2.18","spread":"0.09"},{"groupId":"OG002","value":"1.92","spread":"0.09"},{"groupId":"OG003","value":"1.75","spread":"0.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Since p-value \\<0.025, hierarchically testing continued.","statisticalMethod":"MMRM","paramType":"Mean Difference (Final Values)","paramValue":"-0.69","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.94","ciUpperLimit":"-0.44","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.13","estimateComment":"To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025."},{"groupIds":["OG000","OG002"],"groupDescription":"As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Since p-value \\<0.025, hierarchically testing continued.","statisticalMethod":"MMRM","paramType":"Mean Difference (Final Values)","paramValue":"-0.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.20","ciUpperLimit":"-0.70","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.13","estimateComment":"To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025."},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"This treatment arm was not in the testing sequence. 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