{"protocolSection":{"identificationModule":{"nctId":"NCT00596817","orgStudyIdInfo":{"id":"11985A"},"secondaryIdInfos":[{"id":"2007-001871-13","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes","officialTitle":"A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2014-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-12"},"primaryCompletionDateStruct":{"date":"2009-09","type":"ACTUAL"},"completionDateStruct":{"date":"2009-10","type":"ACTUAL"},"studyFirstSubmitDate":"2008-01-08","studyFirstSubmitQcDate":"2008-01-08","studyFirstPostDateStruct":{"date":"2008-01-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-28","resultsFirstSubmitQcDate":"2014-02-13","resultsFirstPostDateStruct":{"date":"2014-03-31","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-02-13","lastUpdatePostDateStruct":{"date":"2014-03-31","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Relapse prevention","Antidepressants","Placebo-controlled","Double-blind","Multicentre study"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":639,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Vortioxetine: 5 or 10 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Vortioxetine (Lu AA21004)"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"capsules, daily, orally","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Vortioxetine (Lu AA21004)","description":"encapsulated tablets, daily, orally","armGroupLabels":["Vortioxetine: 5 or 10 mg"],"otherNames":["Brintellix"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator","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":"Within first 24 weeks of the double-blind period"}],"secondaryOutcomes":[{"measure":"Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator","timeFrame":"Within 64 weeks of the double-blind period"},{"measure":"Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment","timeFrame":"Double-blind Baseline and Week 24 of the double-blind period"},{"measure":"Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment","description":"The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe.","timeFrame":"Double-blind Baseline and Week 24 of the double-blind period"},{"measure":"Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment","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.","timeFrame":"Double-blind Baseline and Week 24 of the double-blind period"},{"measure":"Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment","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.","timeFrame":"Double-blind Baseline and Week 24 of the double-blind period"},{"measure":"Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)","timeFrame":"Week 24 of the double-blind period (Counted From Open-label Baseline)"},{"measure":"Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)","timeFrame":"Week 24 of the double-blind period"},{"measure":"Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period","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":"Week 24 of the double-blind period (Counted From Double-blind Baseline)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria\n* At least one other MDE before the current one\n* Moderate to severe depression\n\nExclusion Criteria:\n\n* Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR\n* Any substance disorder within the previous 6 months\n* Female patients of childbearing potential who are not using effective contraception\n* Use of any psychoactive medication 2 weeks prior to screening and during the study\n\nRandomisation Criteria: Patients in remission (MADRS total score \\<=10) at both Week 10 and Week 12\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":"22495621","type":"RESULT","citation":"Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9."},{"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":"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."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study consisted of two consecutive periods: a 12-week open-label treatment period with Vortioxetine and a double-blind, fixed-dose, placebo-controlled treatment period of at least 24 weeks.","recruitmentDetails":"Patients were in- and outpatients from psychiatric settings.","groups":[{"id":"FG000","title":"Placebo","description":"Placebo : capsules, daily, orally"},{"id":"FG001","title":"Vortioxetine: 5 or 10 mg","description":"Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally"}],"periods":[{"title":"Open-label Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"639"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"492"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"147"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"33"}]},{"type":"Other Reasons","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"65"}]}]},{"title":"Open-label Period to Double-blind Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"492"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"400"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"92"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"Not Eligible","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"Other Reasons","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"14"}]}]},{"title":"Double-blind Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"194 patients were randomised. 2 did not receive study medication. 192 is full-analysis set (FAS).","numSubjects":"192"},{"groupId":"FG001","comment":"206 patients were randomised. 2 did not receive study medication. 204 is FAS.","numSubjects":"204"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"125"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"88"},{"groupId":"FG001","numSubjects":"79"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"Non-compliance With Study Product","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Other Reasons","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"18"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The total number of patients under Baseline Measures is not 1035 as automatically calculated, but 639 as stated in the \"Open-label Period (APTS)\" column and 396 in the \"Double-blind Period (FAS)\".\n\nThe \"Total\" column of each Baseline Measure is Double-blind Period (FAS).","groups":[{"id":"BG000","title":"Open-label Period (APTS)"},{"id":"BG001","title":"Placebo - Double-blind Period (FAS)","description":"Placebo : capsules, daily, orally"},{"id":"BG002","title":"Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)","description":"Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"639"},{"groupId":"BG001","value":"192"},{"groupId":"BG002","value":"204"},{"groupId":"BG003","value":"1035"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.6","spread":"12.4"},{"groupId":"BG001","value":"45.1","spread":"12.1"},{"groupId":"BG002","value":"44.8","spread":"12.4"},{"groupId":"BG003","value":"45.0","spread":"12.3"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Female (Open-label Period)","categories":[{"measurements":[{"groupId":"BG000","value":"397"},{"groupId":"BG001","value":"NA","comment":"Only data for Open-label Period"},{"groupId":"BG002","value":"NA","comment":"Only data for Open-label Period"},{"groupId":"BG003","value":"NA","comment":"Total not calculated because data are not available (NA) in one or more arms."}]}]},{"title":"Male (Open-label Period)","categories":[{"measurements":[{"groupId":"BG000","value":"242"},{"groupId":"BG001","value":"NA","comment":"Only data for Open-label Period"},{"groupId":"BG002","value":"NA","comment":"Only data for Open-label Period"},{"groupId":"BG003","value":"NA","comment":"Total not calculated because data are not available (NA) in one or more arms."}]}]},{"title":"Female (Double-blind Period)","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"130"},{"groupId":"BG003","value":"250"}]}]},{"title":"Male (Double-blind Period)","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"74"},{"groupId":"BG003","value":"146"}]}]}]},{"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":"32.3","spread":"4.1"},{"groupId":"BG001","value":"4.66","spread":"3.16"},{"groupId":"BG002","value":"4.89","spread":"3.00"},{"groupId":"BG003","value":"4.78","spread":"3.08"}]}]}]},{"title":"HAM-D-17","description":"The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.8","spread":"4.5"},{"groupId":"BG001","value":"3.96","spread":"3.15"},{"groupId":"BG002","value":"4.46","spread":"3.27"},{"groupId":"BG003","value":"4.21","spread":"3.21"}]}]}]},{"title":"HAM-A","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":"22.6","spread":"6.6"},{"groupId":"BG001","value":"4.60","spread":"3.60"},{"groupId":"BG002","value":"5.09","spread":"3.83"},{"groupId":"BG003","value":"4.85","spread":"3.72"}]}]}]},{"title":"CGI-S","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":"4.8","spread":"0.7"},{"groupId":"BG001","value":"1.54","spread":"0.69"},{"groupId":"BG002","value":"1.56","spread":"0.68"},{"groupId":"BG003","value":"1.55","spread":"0.69"}]}]}]},{"title":"SDS","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":"20.8","spread":"5.7"},{"groupId":"BG001","value":"8.37","spread":"7.44"},{"groupId":"BG002","value":"8.95","spread":"7.09"},{"groupId":"BG003","value":"8.66","spread":"7.27"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator","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","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients who relapsed","timeFrame":"Within first 24 weeks of the double-blind period","groups":[{"id":"OG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"OG001","title":"Vortioxetine: 5 or 10 mg","description":"encapsulated tablets, daily, orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"192"},{"groupId":"OG001","value":"204"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.0"},{"groupId":"OG001","value":"13.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0035","statisticalMethod":"Cox-model","statisticalComment":"Cox-model using an exact method to handle ties","paramType":"Hazard Ratio (HR)","paramValue":"2.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.26","ciUpperLimit":"3.21"}]},{"type":"SECONDARY","title":"Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator","populationDescription":"FAS","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients who relapsed","timeFrame":"Within 64 weeks of the double-blind period","groups":[{"id":"OG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"OG001","title":"Vortioxetine: 5 or 10 mg","description":"encapsulated tablets, daily, orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"192"},{"groupId":"OG001","value":"204"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"30.2"},{"groupId":"OG001","value":"15.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0010","pValueComment":"A nominal p-value is provided.","statisticalMethod":"Cox-Model","paramType":"Hazard Ratio (HR)","paramValue":"2.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.35","ciUpperLimit":"3.23"}]},{"type":"SECONDARY","title":"Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment","populationDescription":"FAS; observed cases (OC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Double-blind Baseline and Week 24 of the double-blind period","groups":[{"id":"OG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"OG001","title":"Vortioxetine: 5 or 10 mg","description":"encapsulated tablets, daily, orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"132"},{"groupId":"OG001","value":"151"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.45","spread":"0.55"},{"groupId":"OG001","value":"-0.62","spread":"0.51"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0020","pValueComment":"A nominal p-value is provided.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-2.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.36","ciUpperLimit":"-0.77","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.66"}]},{"type":"SECONDARY","title":"Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment","description":"The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe.","populationDescription":"FAS; OC","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Double-blind Baseline and Week 24 of the double-blind period","groups":[{"id":"OG000","title":"Placebo","description":"capsules, daily, orally"},{"id":"OG001","title":"Vortioxetine: 5 or 10 mg","description":"encapsulated tablets, daily, orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"158"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.61","spread":"0.46"},{"groupId":"OG001","value":"0.30","spread":"0.42"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0171","pValueComment":"A nominal p-value is provided.","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Final Values)","paramValue":"-1.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.39","ciUpperLimit":"-0.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.55"}]},{"type":"SECONDARY","title":"Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment","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. 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