{"protocolSection":{"identificationModule":{"nctId":"NCT01355081","orgStudyIdInfo":{"id":"LuAA21004/CCT-003"},"secondaryIdInfos":[{"id":"U1111-1120-9277","type":"REGISTRY","domain":"WHO"},{"id":"JapicCTI-111492","type":"REGISTRY","domain":"JapicCTI"}],"organization":{"fullName":"Takeda","class":"INDUSTRY"},"briefTitle":"Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2014-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-05"},"primaryCompletionDateStruct":{"date":"2012-12","type":"ACTUAL"},"completionDateStruct":{"date":"2012-12","type":"ACTUAL"},"studyFirstSubmitDate":"2011-05-16","studyFirstSubmitQcDate":"2011-05-16","studyFirstPostDateStruct":{"date":"2011-05-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-11-04","resultsFirstSubmitQcDate":"2014-11-04","resultsFirstPostDateStruct":{"date":"2014-11-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-11-04","lastUpdatePostDateStruct":{"date":"2014-11-11","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Takeda","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder.\n\nThe purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.","detailedDescription":"Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder. Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy. This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period. Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study. Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.\n\nLu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder.\n\nMajor depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy.\n\nThis study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week s safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period.\n\nSubjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study.\n\nSubjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Drug Therapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":366,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine 5 mg","type":"EXPERIMENTAL","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.","interventionNames":["Drug: Vortioxetine"]},{"label":"Vortioxetine 10 mg","type":"EXPERIMENTAL","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.","interventionNames":["Drug: Vortioxetine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine","description":"Vortioxetine tablets","armGroupLabels":["Vortioxetine 10 mg","Vortioxetine 5 mg"],"otherNames":["Lu AA21004","BRINTELLIX"]},{"type":"DRUG","name":"Placebo","description":"Vortioxetine placebo","armGroupLabels":["Placebo"],"otherNames":["Vortioxetine placebo-matching tablets"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment","description":"MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.","timeFrame":"Baseline, Week 8"}],"secondaryOutcomes":[{"measure":"Percentage of Patients With MADRS Response After 8 Weeks of Treatment","description":"MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.","timeFrame":"Baseline, Week 8"},{"measure":"Percentage of Patients With MADRS Remission After 8 Weeks of Treatment","description":"MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.","timeFrame":"Week 8"},{"measure":"Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment","description":"The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.","timeFrame":"Baseline, Week 8"},{"measure":"Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment","description":"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: \"Compared to his condition at the start of the study, how much has this patient changed?\" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate.","timeFrame":"Baseline, Week 8"},{"measure":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment","description":"The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.","timeFrame":"Baseline, Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).\n2. The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.\n3. The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.\n4. The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits\n\nExclusion Criteria:\n\n1. The subject has one or more of the following conditions:\n\n   * Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per 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 any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.\n   * Presence or history of a clinically significant neurological disorder (including epilepsy).\n   * Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.).\n   * Any DSM-IV-TR axis II disorder that might compromise the study.\n2. The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.\n3. The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide within 6 months prior to the Screening Visit.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Senior Manager","affiliation":"Takeda","role":"STUDY_DIRECTOR"}],"locations":[{"city":"Inzai-shi","state":"Chiba","country":"Japan"},{"city":"Noda","state":"Chiba","country":"Japan","geoPoint":{"lat":35.94897,"lon":139.86793}},{"city":"Fukuoka","state":"Fukuoka","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"city":"Kitakyushu-shi","state":"Fukuoka","country":"Japan"},{"city":"Annaka-shi","state":"Gunma","country":"Japan"},{"city":"Fujioka-shi","state":"Gunma","country":"Japan"},{"city":"Takasaki-shi","state":"Gunma","country":"Japan"},{"city":"Hatsukaichi-shi","state":"Hiroshima","country":"Japan"},{"city":"Hiroshima","state":"Hiroshima","country":"Japan","geoPoint":{"lat":34.4,"lon":132.45}},{"city":"Sapporo","state":"Hokkaido","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"city":"Amagasaki-shi","state":"Hyōgo","country":"Japan"},{"city":"Kobe","state":"Hyōgo","country":"Japan","geoPoint":{"lat":34.6913,"lon":135.183}},{"city":"Ibaraki","state":"Ibaraki","country":"Japan"},{"city":"Fujisawa-shi","state":"Kanagawa","country":"Japan"},{"city":"Kawasaki-shi","state":"Kanagawa","country":"Japan"},{"city":"Sagamihara-shi","state":"Kanagawa","country":"Japan"},{"city":"Yokohama","state":"Kanagawa","country":"Japan","geoPoint":{"lat":35.43333,"lon":139.65}},{"city":"Osaka","state":"Kita-ku","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"city":"Kumamoto","state":"Kumamoto","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"city":"Kyoto","state":"Kyoto","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"city":"Kurashiki-shi","state":"Okayama-ken","country":"Japan"},{"city":"Osaka","state":"Osaka","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"city":"Fukaya-shi","state":"Saitama","country":"Japan"},{"city":"Saitama","state":"Saitama","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"city":"Utsunomiya","state":"Tochigi","country":"Japan","geoPoint":{"lat":36.56667,"lon":139.88333}},{"city":"Anan-shi","state":"Tokushima","country":"Japan"},{"city":"Tokushisma-shi","state":"Tokushima","country":"Japan"},{"city":"Hachioji-shi","state":"Tokyo","country":"Japan"},{"city":"Katsushika-ku","state":"Tokyo","country":"Japan","geoPoint":{"lat":35.73333,"lon":139.85}},{"city":"Musashino-shi","state":"Tokyo","country":"Japan"},{"city":"Tokyo","state":"Tokyo","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}},{"city":"Nanyo-shi","state":"Yamagata","country":"Japan"}]},"referencesModule":{"references":[{"pmid":"29160598","type":"DERIVED","citation":"Inoue T, Nishimura A, Sasai K, Kitagawa T. Randomized, 8-week, double-blind, placebo-controlled trial of vortioxetine in Japanese adults with major depressive disorder, followed by a 52-week open-label extension trial. Psychiatry Clin Neurosci. 2018 Feb;72(2):103-115. doi: 10.1111/pcn.12623. Epub 2017 Dec 27."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 3 treatment groups: once a day 5 mg or 10 mg vortioxetine (Lu AA21004) or placebo.","recruitmentDetails":"Participants took part in the study at 32 investigative sites throughout Japan from 13 May 2011 to 21 December 2012.","groups":[{"id":"FG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"FG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"FG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"119"},{"groupId":"FG001","numSubjects":"123"},{"groupId":"FG002","numSubjects":"124"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"112"},{"groupId":"FG001","numSubjects":"113"},{"groupId":"FG002","numSubjects":"113"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"11"}]}],"dropWithdraws":[{"type":"Pretreatment Event or Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Major Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Non Compliance with Study Medication","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"BG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"BG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"119"},{"groupId":"BG001","value":"123"},{"groupId":"BG002","value":"124"},{"groupId":"BG003","value":"366"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38.8","spread":"10.85"},{"groupId":"BG001","value":"38.8","spread":"10.99"},{"groupId":"BG002","value":"37.6","spread":"10.67"},{"groupId":"BG003","value":"38.4","spread":"10.83"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"67"},{"groupId":"BG003","value":"171"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"57"},{"groupId":"BG003","value":"195"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"119"},{"groupId":"BG001","value":"123"},{"groupId":"BG002","value":"124"},{"groupId":"BG003","value":"366"}]}]}]},{"title":"Height","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"165.7","spread":"8.45"},{"groupId":"BG001","value":"165.6","spread":"8.51"},{"groupId":"BG002","value":"163.9","spread":"8.46"},{"groupId":"BG003","value":"165.1","spread":"8.49"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62.18","spread":"11.357"},{"groupId":"BG001","value":"62.11","spread":"15.883"},{"groupId":"BG002","value":"60.86","spread":"12.690"},{"groupId":"BG003","value":"61.71","spread":"13.441"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.59","spread":"3.366"},{"groupId":"BG001","value":"22.42","spread":"4.306"},{"groupId":"BG002","value":"22.57","spread":"4.016"},{"groupId":"BG003","value":"22.53","spread":"3.911"}]}]}]},{"title":"Cytochrome p450 (CYP)2D6 Phenotype","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Ultra-rapid Metabolizer (UM)","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}]},{"title":"Extensive Metabolizer (EM)","categories":[{"measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"97"},{"groupId":"BG002","value":"96"},{"groupId":"BG003","value":"284"}]}]},{"title":"Intermediate Metabolizer (IM)","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"66"}]}]},{"title":"Poor Metabolizer (PM)","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]},{"title":"Unknown","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"11"}]}]}]},{"title":"Smoking Classification","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Current smoker","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"40"},{"groupId":"BG003","value":"120"}]}]},{"title":"Ex-smoker","categories":[{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"74"}]}]},{"title":"Never Smoked","categories":[{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"172"}]}]}]},{"title":"History of Alcohol Consumption","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Never","categories":[{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"41"},{"groupId":"BG003","value":"107"}]}]},{"title":"Once Monthly or Less Often","categories":[{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"40"},{"groupId":"BG003","value":"113"}]}]},{"title":"Once a Week","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"56"}]}]},{"title":"2 to 6 Times/Week","categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"56"}]}]},{"title":"Daily","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"34"}]}]}]},{"title":"Status of Major Depressive Episode (MDE)","description":"An MDE is a period marked by depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Single episode","categories":[{"measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"214"}]}]},{"title":"Recurrent episode","categories":[{"measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"48"},{"groupId":"BG003","value":"152"}]}]}]},{"title":"Pharmacotherapy for Current Major Depressive Episode","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"68"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"74"},{"groupId":"BG003","value":"210"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"50"},{"groupId":"BG003","value":"156"}]}]}]},{"title":"Montgomery Åsberg Depression Rating Scale (MADRS) Total Score","description":"The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.2","spread":"4.81"},{"groupId":"BG001","value":"32.5","spread":"4.93"},{"groupId":"BG002","value":"32.5","spread":"4.50"},{"groupId":"BG003","value":"32.4","spread":"4.74"}]}]}]},{"title":"Hamilton Depression Scale (HAM-D17) Total Score","description":"The HAM-D17 is a clinician-rated scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 where a higher score indicates a greater depressive state.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20.9","spread":"4.12"},{"groupId":"BG001","value":"21.2","spread":"4.43"},{"groupId":"BG002","value":"21.5","spread":"4.48"},{"groupId":"BG003","value":"21.2","spread":"4.34"}]}]}]},{"title":"Clinical Global Impression - Severity Scale Score","description":"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.5","spread":"0.65"},{"groupId":"BG001","value":"4.5","spread":"0.64"},{"groupId":"BG002","value":"4.6","spread":"0.69"},{"groupId":"BG003","value":"4.5","spread":"0.66"}]}]}]},{"title":"Sheehan Disability Scale (SDS) - Total Score","description":"The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15.5","spread":"6.12"},{"groupId":"BG001","value":"15.2","spread":"5.97"},{"groupId":"BG002","value":"15.4","spread":"5.45"},{"groupId":"BG003","value":"15.4","spread":"5.83"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment","description":"MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.","populationDescription":"Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug; who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last observation carried forward.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.84","spread":"0.885"},{"groupId":"OG001","value":"-14.85","spread":"0.874"},{"groupId":"OG002","value":"-13.81","spread":"0.870"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1031","statisticalMethod":"ANCOVA","statisticalComment":"Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.","paramType":"Least square means difference","paramValue":"-2.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.467","ciUpperLimit":"0.413","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.241"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4008","statisticalMethod":"ANCOVA","statisticalComment":"Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.","paramType":"Least square mean difference","paramValue":"-1.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.461","ciUpperLimit":"1.387","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.233"}]},{"type":"SECONDARY","title":"Percentage of Patients With MADRS Response After 8 Weeks of Treatment","description":"MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.","populationDescription":"Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.3"},{"groupId":"OG001","value":"45.9"},{"groupId":"OG002","value":"39.8"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients With MADRS Remission After 8 Weeks of Treatment","description":"MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.","populationDescription":"Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29.4"},{"groupId":"OG001","value":"28.7"},{"groupId":"OG002","value":"22.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment","description":"The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. 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Last Observation Carried Forward.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.56","spread":"0.586"},{"groupId":"OG001","value":"-8.54","spread":"0.580"},{"groupId":"OG002","value":"-8.40","spread":"0.578"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment","description":"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: \"Compared to his condition at the start of the study, how much has this patient changed?\" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate.","populationDescription":"Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"123"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.44","spread":"0.100"},{"groupId":"OG001","value":"2.57","spread":"0.099"},{"groupId":"OG002","value":"2.66","spread":"0.099"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment","description":"The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.","populationDescription":"Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks."},{"id":"OG002","title":"Placebo","description":"Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"119"},{"groupId":"OG001","value":"121"},{"groupId":"OG002","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.01","spread":"0.510"},{"groupId":"OG001","value":"-4.02","spread":"0.506"},{"groupId":"OG002","value":"-2.91","spread":"0.504"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"8-week double blind treatment period and 4-week follow-up safety period, or up to 4 weeks after withdrawal visit, excluding those who enrolled in the long-term extension study (Up to 12 Weeks)","description":"At each visit the investigator documented adverse events and abnormal laboratory findings reported by the patient or observed by the investigator irrespective of relation to study drug. 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(15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":119},{"groupId":"EG001","numAffected":2,"numAtRisk":122},{"groupId":"EG002","numAffected":0,"numAtRisk":124}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":119},{"groupId":"EG001","numAffected":1,"numAtRisk":122},{"groupId":"EG002","numAffected":1,"numAtRisk":124}]},{"term":"Haematochezia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":119},{"groupId":"EG001","numAffected":0,"numAtRisk":122},{"groupId":"EG002","numAffected":1,"numAtRisk":124}]},{"term":"Stomatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":119},{"groupId":"EG001","numAffected":1,"numAtRisk":122},{"groupId":"EG002","numAffected":0,"numAtRisk":124}]},{"term":"Dental caries","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":119},{"groupId":"EG001","numAffected":1,"numAtRisk":122},{"groupId":"EG002","numAffected":0,"numAtRisk":124}]},{"term":"Epigastric discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":119},{"groupId":"EG001","numAffected":1,"numAtRisk":122},{"groupId":"EG002","numAffected":0,"numAtRisk":124}]},{"term":"Haemorrhoids","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":119},{"groupId":"EG001","numAffected":0,"numAtRisk":122},{"groupId":"EG002","numAffected":1,"numAtRisk":124}]},{"term":"Hypoaesthesia oral","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":119},{"groupId":"EG001","numAffected":0,"numAtRisk":122},{"groupId":"EG002","numAffected":1,"numAtRisk":124}]},{"term":"Salivary hypersecretion","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (15.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":119},{"groupId":"EG001","numAffected":0,"numAtRisk":122},{"groupId":"EG002","numAffected":0,"numAtRisk":124}]},{"term":"Thirst","organSystem":"General disorders","sourceVocabulary":"MedDRA 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