{"protocolSection":{"identificationModule":{"nctId":"NCT00735709","orgStudyIdInfo":{"id":"LuAA21004_305"},"secondaryIdInfos":[{"id":"2008-001580-11","type":"EUDRACT_NUMBER"},{"id":"U1111-1114-0326","type":"REGISTRY","domain":"WHO"},{"id":"2008","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2008"}],"organization":{"fullName":"Takeda","class":"INDUSTRY"},"briefTitle":"Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder","officialTitle":"A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-08"},"primaryCompletionDateStruct":{"date":"2009-07","type":"ACTUAL"},"completionDateStruct":{"date":"2009-08","type":"ACTUAL"},"studyFirstSubmitDate":"2008-08-14","studyFirstSubmitQcDate":"2008-08-14","studyFirstPostDateStruct":{"date":"2008-08-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-25","resultsFirstSubmitQcDate":"2013-10-25","resultsFirstPostDateStruct":{"date":"2013-12-18","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-10-25","lastUpdatePostDateStruct":{"date":"2013-12-18","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Takeda","class":"INDUSTRY"},"collaborators":[{"name":"H. Lundbeck A/S","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.","detailedDescription":"The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.\n\nThe study enrolled 560 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):\n\n* Vortioxetine 1 mg\n* Vortioxetine 5 mg\n* Vortioxetine 10 mg\n* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.\n\nAll participants were asked to take one capsule at the same time each day throughout the study.\n\nThis multi-centre trial was conducted in Europe, Asia, Australia, and South Africa. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Depression","Depressive Disorder","Mood Disorder","Mental Disorder","Melancholia, Involutional","Paraphrenia, Involutional","Drug Therapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":560,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine 1 mg","type":"EXPERIMENTAL","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.","interventionNames":["Drug: Vortioxetine"]},{"label":"Vortioxetine 5 mg","type":"EXPERIMENTAL","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.","interventionNames":["Drug: Vortioxetine"]},{"label":"Vortioxetine 10 mg","type":"EXPERIMENTAL","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.","interventionNames":["Drug: Vortioxetine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine","description":"Encapsulated immediate-release vortioxetine tablets","armGroupLabels":["Vortioxetine 1 mg","Vortioxetine 10 mg","Vortioxetine 5 mg"],"otherNames":["Lu AA21004","Brintellix®"]},{"type":"DRUG","name":"Placebo","description":"Vortioxetine placebo-matching capsules","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8","description":"The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item 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 range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline to Week 8"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8","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. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline to Week 8"},{"measure":"Clinical Global Impression Scale-Global Improvement at Week 8","description":"The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline to Week 8"},{"measure":"Percentage of Responders in HAM-D24 Total Score at Week 8","description":"A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item 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 74, where a higher score indicates a greater depressive state.","timeFrame":"Baseline and Week 8"},{"measure":"Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20","description":"The HAM-D24 is a clinician-rated 24-item 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 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline to Week 8"},{"measure":"Percentage of Participants in MADRS Remission at Week 8","description":"Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The 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). Decrease in the total score or on individual items indicates improvement.","timeFrame":"Week 8"},{"measure":"Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed","description":"The HAM-D24 is a clinician-rated 24-item 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 range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 1, 2, 4 and 6"},{"measure":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed","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. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 1, 2 and 6"},{"measure":"Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed","description":"The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 1, 2, 4 and 6"},{"measure":"Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed","description":"A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item 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 74, where a higher score indicates a greater depressive state.","timeFrame":"Baseline and Weeks 1, 2, 4 and 6"},{"measure":"Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20","description":"The HAM-D24 is a clinician-rated 24-item 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 range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 1, 2, 4 and 6"},{"measure":"Percentage of Participants in MADRS Remission at Other Weeks Assessed","description":"Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The 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). Decrease in the total score or on individual items indicates improvement.","timeFrame":"Weeks 1, 2, 4 and 6"},{"measure":"Percentage of Participants With a Sustained Response in HAM-D24 Total Score","description":"A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.","timeFrame":"From Baseline through Week 8"},{"measure":"Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week","description":"The 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). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 1, 2, 4, 6, and 8"},{"measure":"Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed","description":"The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 to 56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 1, 2, 4, 6, and 8"},{"measure":"Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed","description":"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness 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. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 1, 2, 4, 6, and 8"},{"measure":"Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed","description":"The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis","timeFrame":"Baseline and Weeks 1, 4, and 8"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2, 4 and 8"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2, 4 and 8"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2, 4 and 8"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2, 4 and 8"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2, 4 and 8"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2 and 4"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2, 4 and 8"},{"measure":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","timeFrame":"Baseline and Weeks 2, 4 and 8"},{"measure":"Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.","description":"Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.","timeFrame":"Baseline and Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.\n* The reported duration of the current major depressive episode is at least 3 months.\n* Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.\n* A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.\n\nExclusion Criteria:\n\n* Has 1 or more the following:\n\n  * Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.\n  * Current or past 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  * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).\n  * Presence or history of a clinically significant neurological disorder (including epilepsy).\n  * Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).\n* Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months.\n* Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.\n* Has a clinically significant unstable illness.\n* Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.\n* Has received electroconvulsive therapy within 6 months prior to Screening.\n* Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level \\> 1.5 times the upper limit of normal.\n* Has a serum creatinine of \\> 1.5 × upper limit of normal.\n* Has a previous history of cancer that had been in remission for less than 5 years.\n* Has thyroid stimulating hormone value outside the normal range.\n* Has an abnormal electrocardiogram.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Medical Director Clinical Science","affiliation":"Takeda","role":"STUDY_DIRECTOR"}],"locations":[{"city":"Elizabeth Vale","country":"Australia","geoPoint":{"lat":-34.74857,"lon":138.66819}},{"city":"Southport","country":"Australia","geoPoint":{"lat":-27.96724,"lon":153.39796}},{"city":"Litoměřice","country":"Czechia","geoPoint":{"lat":50.53348,"lon":14.1318}},{"city":"Lnáře","country":"Czechia","geoPoint":{"lat":49.4579,"lon":13.78406}},{"city":"Prague","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"city":"Bully-les-Mines","country":"France","geoPoint":{"lat":50.4438,"lon":2.72703}},{"city":"Marseille","country":"France","geoPoint":{"lat":43.29695,"lon":5.38107}},{"city":"Strasbourg","country":"France","geoPoint":{"lat":48.58392,"lon":7.74553}},{"city":"Bochum","country":"Germany","geoPoint":{"lat":51.48165,"lon":7.21648}},{"city":"Chemnitz","country":"Germany","geoPoint":{"lat":50.8357,"lon":12.92922}},{"city":"Dillingen","country":"Germany","geoPoint":{"lat":49.35557,"lon":6.72781}},{"city":"Hüttenberg","country":"Germany","geoPoint":{"lat":48.20658,"lon":12.65094}},{"city":"Leipzig","country":"Germany","geoPoint":{"lat":51.33962,"lon":12.37129}},{"city":"München","country":"Germany","geoPoint":{"lat":51.60698,"lon":13.31243}},{"city":"Nuremberg","country":"Germany","geoPoint":{"lat":49.45421,"lon":11.07752}},{"city":"Osnabrück","country":"Germany","geoPoint":{"lat":52.27264,"lon":8.0498}},{"city":"Rodgau","country":"Germany","geoPoint":{"lat":50.02627,"lon":8.88588}},{"city":"Westerstede","country":"Germany","geoPoint":{"lat":53.25682,"lon":7.92737}},{"city":"Leipaja","country":"Latvia"},{"city":"Riga","country":"Latvia","geoPoint":{"lat":56.946,"lon":24.10589}},{"city":"Sigulda","country":"Latvia","geoPoint":{"lat":57.15375,"lon":24.85953}},{"city":"Strenči","country":"Latvia","geoPoint":{"lat":57.62574,"lon":25.68535}},{"city":"Vilnius","country":"Lithuania","geoPoint":{"lat":54.68916,"lon":25.2798}},{"city":"Kuala Lumpur","country":"Malaysia","geoPoint":{"lat":3.1412,"lon":101.68653}},{"city":"Wildervank","country":"Netherlands","geoPoint":{"lat":53.08083,"lon":6.8625}},{"city":"Bialystok","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"city":"Leszno","country":"Poland","geoPoint":{"lat":51.84034,"lon":16.57494}},{"city":"Skórzewo","country":"Poland","geoPoint":{"lat":53.03629,"lon":17.81889}},{"city":"Torun","country":"Poland","geoPoint":{"lat":53.01375,"lon":18.59814}},{"city":"Tuszyn","country":"Poland","geoPoint":{"lat":51.60949,"lon":19.53009}},{"city":"Moscow","country":"Russia","geoPoint":{"lat":55.75204,"lon":37.61781}},{"city":"Saint Petersburg","country":"Russia","geoPoint":{"lat":59.93863,"lon":30.31413}},{"city":"Stavropol","country":"Russia","geoPoint":{"lat":45.03442,"lon":41.9642}},{"city":"Tomsk","country":"Russia","geoPoint":{"lat":56.50049,"lon":84.98216}},{"city":"Velikiy Novgorod","country":"Russia","geoPoint":{"lat":58.52131,"lon":31.27104}},{"city":"Durban","country":"South Africa","geoPoint":{"lat":-29.8579,"lon":31.0292}},{"city":"Noordheuwel","country":"South Africa","geoPoint":{"lat":-26.08639,"lon":27.79223}},{"city":"Pretoria","country":"South Africa","geoPoint":{"lat":-25.74486,"lon":28.18783}},{"city":"Bucheon-si","country":"South Korea","geoPoint":{"lat":37.49889,"lon":126.78306}},{"city":"Namdong-gu","country":"South Korea"},{"city":"Seoul","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"city":"Lin-Yan District","country":"Taiwan"},{"city":"Dnipro","country":"Ukraine","geoPoint":{"lat":48.46664,"lon":35.04066}},{"city":"Kharkiv","country":"Ukraine","geoPoint":{"lat":49.98177,"lon":36.25475}},{"city":"Luhansk","country":"Ukraine","geoPoint":{"lat":48.56814,"lon":39.30553}},{"city":"Simferopol","country":"Ukraine","geoPoint":{"lat":44.95719,"lon":34.11079}},{"city":"Bath","country":"United Kingdom","geoPoint":{"lat":51.3751,"lon":-2.36172}},{"city":"Bolton","country":"United Kingdom","geoPoint":{"lat":53.58333,"lon":-2.43333}}]},"referencesModule":{"references":[{"pmid":"22901346","type":"BACKGROUND","citation":"Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470."},{"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":"Participants with a diagnosis of major depressive disorder were randomized equally in 1 of 4 treatment groups, once daily placebo, 1 mg, 5 mg, or 10 mg vortioxetine.","recruitmentDetails":"Participants took part in the study at 51 investigative sites in Australia, Croatia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Republic of Korea, Russia, South Africa, Taiwan, and Ukraine from 14 August 2008 to 13 August 2009.","groups":[{"id":"FG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"FG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"FG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"FG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"140"},{"groupId":"FG001","numSubjects":"140"},{"groupId":"FG002","numSubjects":"140"},{"groupId":"FG003","numSubjects":"140"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"140"},{"groupId":"FG001","numSubjects":"140"},{"groupId":"FG002","numSubjects":"140"},{"groupId":"FG003","numSubjects":"139"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"127"},{"groupId":"FG001","numSubjects":"127"},{"groupId":"FG002","numSubjects":"129"},{"groupId":"FG003","numSubjects":"122"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"18"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Protocol deviations","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Voluntary Withdrawal","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"7"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Excluded medication","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"BG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"BG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"BG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"140"},{"groupId":"BG001","value":"140"},{"groupId":"BG002","value":"140"},{"groupId":"BG003","value":"140"},{"groupId":"BG004","value":"560"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.4","spread":"12.26"},{"groupId":"BG001","value":"45.4","spread":"11.89"},{"groupId":"BG002","value":"47.3","spread":"11.95"},{"groupId":"BG003","value":"46.4","spread":"12.27"},{"groupId":"BG004","value":"46.4","spread":"12.08"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"≤55 years","categories":[{"measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"110"},{"groupId":"BG002","value":"102"},{"groupId":"BG003","value":"107"},{"groupId":"BG004","value":"422"}]}]},{"title":">55 years","categories":[{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"33"},{"groupId":"BG004","value":"138"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"86"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"87"},{"groupId":"BG003","value":"85"},{"groupId":"BG004","value":"351"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"53"},{"groupId":"BG003","value":"55"},{"groupId":"BG004","value":"209"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Caucasian","categories":[{"measurements":[{"groupId":"BG000","value":"120"},{"groupId":"BG001","value":"129"},{"groupId":"BG002","value":"120"},{"groupId":"BG003","value":"114"},{"groupId":"BG004","value":"483"}]}]},{"title":"Black","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"10"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"23"},{"groupId":"BG004","value":"62"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"5"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Hispanic/Latino","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"4"}]}]},{"title":"Non-Hispanic/Non-Latino","categories":[{"measurements":[{"groupId":"BG000","value":"137"},{"groupId":"BG001","value":"140"},{"groupId":"BG002","value":"140"},{"groupId":"BG003","value":"139"},{"groupId":"BG004","value":"556"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Australia","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"4"}]}]},{"title":"Croatia","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"13"}]}]},{"title":"France","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"13"}]}]},{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"64"},{"groupId":"BG003","value":"56"},{"groupId":"BG004","value":"233"}]}]},{"title":"Latvia","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"27"}]}]},{"title":"Lithuania","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"13"}]}]},{"title":"Malaysia","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"22"}]}]},{"title":"Netherlands","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"7"}]}]},{"title":"Poland","categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"62"}]}]},{"title":"Republic of Korea","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"35"}]}]},{"title":"Russia","categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"61"}]}]},{"title":"South Africa","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"19"}]}]},{"title":"Taiwan","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"4"}]}]},{"title":"Ukraine","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"47"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"75.18","spread":"14.924"},{"groupId":"BG001","value":"75.63","spread":"17.276"},{"groupId":"BG002","value":"75.41","spread":"17.022"},{"groupId":"BG003","value":"74.58","spread":"15.190"},{"groupId":"BG004","value":"75.20","spread":"16.099"}]}]}]},{"title":"Height","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"168.70","spread":"8.907"},{"groupId":"BG001","value":"168.56","spread":"8.264"},{"groupId":"BG002","value":"168.56","spread":"9.126"},{"groupId":"BG003","value":"168.70","spread":"10.209"},{"groupId":"BG004","value":"168.63","spread":"9.129"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"26.36","spread":"4.615"},{"groupId":"BG001","value":"26.53","spread":"5.380"},{"groupId":"BG002","value":"26.41","spread":"5.065"},{"groupId":"BG003","value":"26.16","spread":"4.612"},{"groupId":"BG004","value":"26.36","spread":"4.917"}]}]}]},{"title":"Smoking Classification","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Never smoked","categories":[{"measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"88"},{"groupId":"BG003","value":"79"},{"groupId":"BG004","value":"329"}]}]},{"title":"Current smoker","categories":[{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"41"},{"groupId":"BG004","value":"162"}]}]},{"title":"Ex-smoker","categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"69"}]}]}]},{"title":"Alcohol Consumption","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Never","categories":[{"measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"56"},{"groupId":"BG003","value":"54"},{"groupId":"BG004","value":"214"}]}]},{"title":"Once monthly or less often","categories":[{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"60"},{"groupId":"BG002","value":"59"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"227"}]}]},{"title":"Once per week","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"54"}]}]},{"title":"2-to-6 times/week","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"35"}]}]},{"title":"Daily","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"30"}]}]}]},{"title":"24-item Hamilton Depression Scale total score","description":"The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item 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 74, 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":"32.7","spread":"4.40"},{"groupId":"BG001","value":"32.5","spread":"5.13"},{"groupId":"BG002","value":"32.1","spread":"5.04"},{"groupId":"BG003","value":"33.1","spread":"4.77"},{"groupId":"BG004","value":"32.6","spread":"4.84"}]}]}]},{"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":"30.6","spread":"2.89"},{"groupId":"BG001","value":"30.4","spread":"3.01"},{"groupId":"BG002","value":"30.6","spread":"2.83"},{"groupId":"BG003","value":"31.6","spread":"3.83"},{"groupId":"BG004","value":"30.8","spread":"3.19"}]}]}]},{"title":"Hamilton Anxiety Scale total score","description":"Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 to 56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19.7","spread":"7.07"},{"groupId":"BG001","value":"20.0","spread":"6.41"},{"groupId":"BG002","value":"19.4","spread":"6.77"},{"groupId":"BG003","value":"21.1","spread":"7.39"},{"groupId":"BG004","value":"20.0","spread":"6.93"}]}]}]},{"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":"4.8","spread":"0.80"},{"groupId":"BG001","value":"4.7","spread":"0.73"},{"groupId":"BG002","value":"4.8","spread":"0.73"},{"groupId":"BG003","value":"4.9","spread":"0.76"},{"groupId":"BG004","value":"4.8","spread":"0.76"}]}]}]},{"title":"Hospital Anxiety and Depression (HAD) - Anxiety subscale","description":"The HAD-anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11.2","spread":"3.99"},{"groupId":"BG001","value":"11.2","spread":"3.83"},{"groupId":"BG002","value":"11.6","spread":"4.02"},{"groupId":"BG003","value":"11.7","spread":"3.97"},{"groupId":"BG004","value":"11.4","spread":"3.95"}]}]}]},{"title":"Hospital Anxiety and Depression - Depression subscale","description":"The HAD - Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13.7","spread":"4.33"},{"groupId":"BG001","value":"13.8","spread":"3.88"},{"groupId":"BG002","value":"13.4","spread":"4.02"},{"groupId":"BG003","value":"13.8","spread":"3.71"},{"groupId":"BG004","value":"13.7","spread":"3.99"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8","description":"The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item 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 range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline to Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"129"},{"groupId":"OG003","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.30","spread":"0.738"},{"groupId":"OG001","value":"-14.82","spread":"0.745"},{"groupId":"OG002","value":"-15.42","spread":"0.743"},{"groupId":"OG003","value":"-16.23","spread":"0.755"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Pre-specified sequential statistical testing procedure indicates that when p-value \\<0.05, hierarchical testing continues.","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-4.93","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.99","ciUpperLimit":"-2.86"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-4.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.17","ciUpperLimit":"-2.08"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"This treatment arm is not in the testing sequence, a nominal p-value is provided.","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-3.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.57","ciUpperLimit":"-1.47"}]},{"type":"SECONDARY","title":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8","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. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline to Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"90"},{"groupId":"OG002","value":"97"},{"groupId":"OG003","value":"83"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.54","spread":"0.716"},{"groupId":"OG001","value":"-6.58","spread":"0.729"},{"groupId":"OG002","value":"-7.65","spread":"0.713"},{"groupId":"OG003","value":"-8.08","spread":"0.756"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.135","pValueComment":"Pre-specified sequential statistical testing procedure indicates that when p-value \\>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.","statisticalMethod":"Mixed model repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-1.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.56","ciUpperLimit":"0.48"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.263","statisticalMethod":"Mixed model repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-1.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.07","ciUpperLimit":"0.84"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.963","statisticalMethod":"Mixed model repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.03","ciUpperLimit":"1.94"}]},{"type":"SECONDARY","title":"Clinical Global Impression Scale-Global Improvement at Week 8","description":"The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline to Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"129"},{"groupId":"OG003","value":"122"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.84","spread":"0.089"},{"groupId":"OG001","value":"2.37","spread":"0.090"},{"groupId":"OG002","value":"2.37","spread":"0.089"},{"groupId":"OG003","value":"2.29","spread":"0.091"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed model repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-0.55","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.80","ciUpperLimit":"-0.30"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed model repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.71","ciUpperLimit":"-0.22"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed model repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.72","ciUpperLimit":"-0.23"}]},{"type":"SECONDARY","title":"Percentage of Responders in HAM-D24 Total Score at Week 8","description":"A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item 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 74, where a higher score indicates a greater depressive state.","populationDescription":"Full analysis set; last observation carried forward (LOCF) was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.0"},{"groupId":"OG001","value":"47.5"},{"groupId":"OG002","value":"45.3"},{"groupId":"OG003","value":"49.6"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","statisticalComment":"Regression with explanatory variables for treatment and Baseline HAM-D24 score.","paramType":"Odds Ratio (OR)","paramValue":"3.348","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.995","ciUpperLimit":"5.618","estimateComment":"Odds ratio versus placebo."},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","statisticalComment":"Regression with explanatory variables for treatment and Baseline HAM-D24 score.","paramType":"Odds Ratio (OR)","paramValue":"2.739","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.631","ciUpperLimit":"4.598","estimateComment":"Odds ratio versus placebo"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Regression, Logistic","statisticalComment":"Regression with explanatory variables for treatment and Baseline HAM-D24 score.","paramType":"Odds Ratio (OR)","paramValue":"3.018","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.799","ciUpperLimit":"5.063","estimateComment":"Odds ratio versus placebo"}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20","description":"The HAM-D24 is a clinician-rated 24-item 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 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline to Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"65"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.02","spread":"1.017"},{"groupId":"OG001","value":"-15.16","spread":"0.991"},{"groupId":"OG002","value":"-15.50","spread":"1.063"},{"groupId":"OG003","value":"-15.61","spread":"0.984"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-4.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.34","ciUpperLimit":"-1.84"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-4.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.32","ciUpperLimit":"-1.62"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","paramType":"LS Mean Difference","paramValue":"-4.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.90","ciUpperLimit":"-1.37"}]},{"type":"SECONDARY","title":"Percentage of Participants in MADRS Remission at Week 8","description":"Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The 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). Decrease in the total score or on individual items indicates improvement.","populationDescription":"Full analysis set; LOCF was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.5"},{"groupId":"OG001","value":"25.9"},{"groupId":"OG002","value":"28.8"},{"groupId":"OG003","value":"26.6"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.026","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.951","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.082","ciUpperLimit":"3.517"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.015","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"2.056","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.150","ciUpperLimit":"3.673"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.062","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.753","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.973","ciUpperLimit":"3.158"}]},{"type":"SECONDARY","title":"Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed","description":"The HAM-D24 is a clinician-rated 24-item 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 range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2, 4 and 6","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Week 1 (n=139, 137, 138, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.47","spread":"0.321"},{"groupId":"OG001","value":"-2.81","spread":"0.323"},{"groupId":"OG002","value":"-3.20","spread":"0.322"},{"groupId":"OG003","value":"-3.20","spread":"0.321"}]}]},{"title":"Week 2 (n=138, 138, 135, 135)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.66","spread":"0.485"},{"groupId":"OG001","value":"-7.27","spread":"0.485"},{"groupId":"OG002","value":"-7.27","spread":"0.490"},{"groupId":"OG003","value":"-7.42","spread":"0.489"}]}]},{"title":"Week 4 (n=135, 133, 135, 127)","categories":[{"measurements":[{"groupId":"OG000","value":"-8.42","spread":"0.634"},{"groupId":"OG001","value":"-11.09","spread":"0.637"},{"groupId":"OG002","value":"-11.00","spread":"0.639"},{"groupId":"OG003","value":"-11.88","spread":"0.646"}]}]},{"title":"Week 6 (n=134, 130, 129, 126)","categories":[{"measurements":[{"groupId":"OG000","value":"-10.23","spread":"0.690"},{"groupId":"OG001","value":"-13.35","spread":"0.695"},{"groupId":"OG002","value":"-13.67","spread":"0.697"},{"groupId":"OG003","value":"-15.22","spread":"0.705"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed","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. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2 and 6","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"103"},{"groupId":"OG002","value":"106"},{"groupId":"OG003","value":"99"}]}],"classes":[{"title":"Week 1 (n=104, 101, 105, 97)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.22","spread":"0.392"},{"groupId":"OG001","value":"-1.13","spread":"0.399"},{"groupId":"OG002","value":"-1.78","spread":"0.393"},{"groupId":"OG003","value":"-1.43","spread":"0.403"}]}]},{"title":"Week 2 (n=102, 101, 100, 96)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.53","spread":"0.507"},{"groupId":"OG001","value":"-3.44","spread":"0.511"},{"groupId":"OG002","value":"-4.14","spread":"0.512"},{"groupId":"OG003","value":"-3.40","spread":"0.521"}]}]},{"title":"Week 6 (n=99, 97, 97, 88)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.95","spread":"0.672"},{"groupId":"OG001","value":"-5.69","spread":"0.681"},{"groupId":"OG002","value":"-6.92","spread":"0.678"},{"groupId":"OG003","value":"-8.27","spread":"0.707"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed","description":"The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2, 4 and 6","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Week 1 (n=139, 137, 138, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"3.65","spread":"0.053"},{"groupId":"OG001","value":"3.71","spread":"0.054"},{"groupId":"OG002","value":"3.67","spread":"0.053"},{"groupId":"OG003","value":"3.64","spread":"0.053"}]}]},{"title":"Week 2 (n=138, 138, 135, 135)","categories":[{"measurements":[{"groupId":"OG000","value":"3.40","spread":"0.069"},{"groupId":"OG001","value":"3.16","spread":"0.070"},{"groupId":"OG002","value":"3.19","spread":"0.070"},{"groupId":"OG003","value":"3.23","spread":"0.070"}]}]},{"title":"Week 4 (n=135, 133, 135, 127)","categories":[{"measurements":[{"groupId":"OG000","value":"3.03","spread":"0.082"},{"groupId":"OG001","value":"2.69","spread":"0.083"},{"groupId":"OG002","value":"2.82","spread":"0.083"},{"groupId":"OG003","value":"2.78","spread":"0.084"}]}]},{"title":"Week 6 (n=134, 130, 129, 126)","categories":[{"measurements":[{"groupId":"OG000","value":"2.95","spread":"0.087"},{"groupId":"OG001","value":"2.48","spread":"0.088"},{"groupId":"OG002","value":"2.50","spread":"0.088"},{"groupId":"OG003","value":"2.37","spread":"0.089"}]}]}]},{"type":"SECONDARY","title":"Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed","description":"A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item 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 74, where a higher score indicates a greater depressive state.","populationDescription":"Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline and Weeks 1, 2, 4 and 6","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Week 1 (n=139, 137, 138, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"0.7"},{"groupId":"OG001","value":"0.7"},{"groupId":"OG002","value":"0.7"},{"groupId":"OG003","value":"1.4"}]}]},{"title":"Week 2 (n=139, 139, 139, 139)","categories":[{"measurements":[{"groupId":"OG000","value":"5.0"},{"groupId":"OG001","value":"7.9"},{"groupId":"OG002","value":"7.2"},{"groupId":"OG003","value":"8.6"}]}]},{"title":"Week 4 (n=139, 139, 139, 139)","categories":[{"measurements":[{"groupId":"OG000","value":"18.0"},{"groupId":"OG001","value":"27.3"},{"groupId":"OG002","value":"24.5"},{"groupId":"OG003","value":"26.6"}]}]},{"title":"Week 6 (n=139, 139, 139, 139)","categories":[{"measurements":[{"groupId":"OG000","value":"23.7"},{"groupId":"OG001","value":"38.1"},{"groupId":"OG002","value":"36.0"},{"groupId":"OG003","value":"43.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20","description":"The HAM-D24 is a clinician-rated 24-item 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 range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2, 4 and 6","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"62"},{"groupId":"OG003","value":"75"}]}],"classes":[{"title":"Week 1 (n=66, 70, 62, 75)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.79","spread":"0.473"},{"groupId":"OG001","value":"-2.94","spread":"0.463"},{"groupId":"OG002","value":"-3.55","spread":"0.491"},{"groupId":"OG003","value":"-3.19","spread":"0.447"}]}]},{"title":"Week 2 (n=65, 70, 59, 72)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.76","spread":"0.637"},{"groupId":"OG001","value":"-7.21","spread":"0.618"},{"groupId":"OG002","value":"-6.58","spread":"0.667"},{"groupId":"OG003","value":"-7.74","spread":"0.607"}]}]},{"title":"Week 4 (n=64, 68, 60, 69)","categories":[{"measurements":[{"groupId":"OG000","value":"-8.56","spread":"0.874"},{"groupId":"OG001","value":"-11.41","spread":"0.850"},{"groupId":"OG002","value":"-10.20","spread":"0.910"},{"groupId":"OG003","value":"-12.06","spread":"0.841"}]}]},{"title":"Week 6 (n=64, 67, 57, 68)","categories":[{"measurements":[{"groupId":"OG000","value":"-10.25","spread":"0.958"},{"groupId":"OG001","value":"-13.68","spread":"0.932"},{"groupId":"OG002","value":"-13.23","spread":"1.002"},{"groupId":"OG003","value":"-15.10","spread":"0.923"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants in MADRS Remission at Other Weeks Assessed","description":"Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The 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). Decrease in the total score or on individual items indicates improvement.","populationDescription":"Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Weeks 1, 2, 4 and 6","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Week 1 (n=139, 137, 138, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"0.7"},{"groupId":"OG001","value":"0.7"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 2 (n=139, 139, 139, 139)","categories":[{"measurements":[{"groupId":"OG000","value":"2.2"},{"groupId":"OG001","value":"2.2"},{"groupId":"OG002","value":"1.4"},{"groupId":"OG003","value":"1.4"}]}]},{"title":"Week 4 (n=139, 139, 139, 139)","categories":[{"measurements":[{"groupId":"OG000","value":"6.5"},{"groupId":"OG001","value":"11.5"},{"groupId":"OG002","value":"11.5"},{"groupId":"OG003","value":"10.8"}]}]},{"title":"Week 6 (n=139, 139, 139, 139)","categories":[{"measurements":[{"groupId":"OG000","value":"10.1"},{"groupId":"OG001","value":"20.1"},{"groupId":"OG002","value":"20.9"},{"groupId":"OG003","value":"22.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants With a Sustained Response in HAM-D24 Total Score","description":"A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"From Baseline through Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.1"},{"groupId":"OG001","value":"9.4"},{"groupId":"OG002","value":"10.1"},{"groupId":"OG003","value":"10.8"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week","description":"The 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). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2, 4, 6, and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Week 1 (n=139, 137, 138, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.90","spread":"0.324"},{"groupId":"OG001","value":"-2.55","spread":"0.326"},{"groupId":"OG002","value":"-2.66","spread":"0.324"},{"groupId":"OG003","value":"-2.57","spread":"0.328"}]}]},{"title":"Week 2 (n=138, 138, 135, 135)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.92","spread":"0.463"},{"groupId":"OG001","value":"-6.65","spread":"0.463"},{"groupId":"OG002","value":"-6.40","spread":"0.467"},{"groupId":"OG003","value":"-6.51","spread":"0.472"}]}]},{"title":"Week 4 (n=135, 133, 135, 127)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.85","spread":"0.619"},{"groupId":"OG001","value":"-10.79","spread":"0.622"},{"groupId":"OG002","value":"-10.30","spread":"0.622"},{"groupId":"OG003","value":"-10.89","spread":"0.635"}]}]},{"title":"Week 6 (n=134, 130, 129, 126)","categories":[{"measurements":[{"groupId":"OG000","value":"-9.72","spread":"0.675"},{"groupId":"OG001","value":"-13.16","spread":"0.680"},{"groupId":"OG002","value":"-13.10","spread":"0.680"},{"groupId":"OG003","value":"-14.19","spread":"0.694"}]}]},{"title":"Week 8 (n=128, 124, 129, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"-10.91","spread":"0.708"},{"groupId":"OG001","value":"-14.89","spread":"0.715"},{"groupId":"OG002","value":"-15.09","spread":"0.712"},{"groupId":"OG003","value":"-15.65","spread":"0.728"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed","description":"The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior 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 scores range from 0 to 56, where \\<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2, 4, 6, and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Week 1 (n=139, 137, 138, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.58","spread":"0.260"},{"groupId":"OG001","value":"-1.27","spread":"0.261"},{"groupId":"OG002","value":"-1.41","spread":"0.261"},{"groupId":"OG003","value":"-1.56","spread":"0.261"}]}]},{"title":"Week 2 (n=138, 138, 135, 135)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.06","spread":"0.343"},{"groupId":"OG001","value":"-3.72","spread":"0.343"},{"groupId":"OG002","value":"-3.09","spread":"0.346"},{"groupId":"OG003","value":"-3.77","spread":"0.347"}]}]},{"title":"Week 4 (n=135, 133, 135, 127)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.54","spread":"0.416"},{"groupId":"OG001","value":"-5.95","spread":"0.418"},{"groupId":"OG002","value":"-5.60","spread":"0.418"},{"groupId":"OG003","value":"-6.11","spread":"0.425"}]}]},{"title":"Week 6 (n=134, 130, 129, 126)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.44","spread":"0.471"},{"groupId":"OG001","value":"-7.29","spread":"0.475"},{"groupId":"OG002","value":"-7.21","spread":"0.476"},{"groupId":"OG003","value":"-8.33","spread":"0.483"}]}]},{"title":"Week 8 (n=128, 124, 129, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.98","spread":"0.498"},{"groupId":"OG001","value":"-8.08","spread":"0.503"},{"groupId":"OG002","value":"-8.11","spread":"0.501"},{"groupId":"OG003","value":"-8.86","spread":"0.511"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed","description":"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness 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. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2, 4, 6, and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Week 1 (n=139, 137, 138, 138)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.24","spread":"0.044"},{"groupId":"OG001","value":"-0.20","spread":"0.045"},{"groupId":"OG002","value":"-0.22","spread":"0.044"},{"groupId":"OG003","value":"-0.24","spread":"0.044"}]}]},{"title":"Week 2 (n=138, 138, 135, 135)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.46","spread":"0.062"},{"groupId":"OG001","value":"-0.58","spread":"0.062"},{"groupId":"OG002","value":"-0.61","spread":"0.062"},{"groupId":"OG003","value":"-0.60","spread":"0.062"}]}]},{"title":"Week 4 (n=135, 133, 135, 127)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.75","spread":"0.080"},{"groupId":"OG001","value":"-1.07","spread":"0.081"},{"groupId":"OG002","value":"-1.10","spread":"0.081"},{"groupId":"OG003","value":"-1.06","spread":"0.082"}]}]},{"title":"Week 6 (n=134, 130, 129, 126)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.96","spread":"0.092"},{"groupId":"OG001","value":"-1.41","spread":"0.093"},{"groupId":"OG002","value":"-1.38","spread":"0.093"},{"groupId":"OG003","value":"-1.55","spread":"0.094"}]}]},{"title":"Week 8 (n=128, 124, 129, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.12","spread":"0.101"},{"groupId":"OG001","value":"-1.50","spread":"0.102"},{"groupId":"OG002","value":"-1.63","spread":"0.101"},{"groupId":"OG003","value":"-1.74","spread":"0.103"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed","description":"The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis","populationDescription":"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 4, and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"138"}]}],"classes":[{"title":"Anxiety Scale at Week 1 (n=139, 137, 138, 137)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.46","spread":"0.190"},{"groupId":"OG001","value":"-1.14","spread":"0.190"},{"groupId":"OG002","value":"-0.87","spread":"0.189"},{"groupId":"OG003","value":"-0.91","spread":"0.190"}]}]},{"title":"Anxiety Scale at Week 4 (n=137, 138, 135, 134)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.95","spread":"0.277"},{"groupId":"OG001","value":"-2.83","spread":"0.276"},{"groupId":"OG002","value":"-2.81","spread":"0.278"},{"groupId":"OG003","value":"-2.80","spread":"0.279"}]}]},{"title":"Anxiety Scale at Week 8 (n=129, 129, 127, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.55","spread":"0.315"},{"groupId":"OG001","value":"-3.79","spread":"0.315"},{"groupId":"OG002","value":"-3.70","spread":"0.317"},{"groupId":"OG003","value":"-4.38","spread":"0.321"}]}]},{"title":"Depression Scale at Week 1 (n=139, 137, 138, 137)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.217"},{"groupId":"OG001","value":"-0.90","spread":"0.217"},{"groupId":"OG002","value":"-0.74","spread":"0.216"},{"groupId":"OG003","value":"-0.92","spread":"0.218"}]}]},{"title":"Depression Scale at Week 4 (n=137, 138, 135, 134)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.32","spread":"0.348"},{"groupId":"OG001","value":"-3.45","spread":"0.347"},{"groupId":"OG002","value":"-3.32","spread":"0.350"},{"groupId":"OG003","value":"-3.80","spread":"0.352"}]}]},{"title":"Depression Scale at Week 8 (n=129, 129, 127, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.19","spread":"0.392"},{"groupId":"OG001","value":"-4.67","spread":"0.393"},{"groupId":"OG002","value":"-5.02","spread":"0.396"},{"groupId":"OG003","value":"-5.49","spread":"0.401"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2, 4 and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138,139,136,136)","categories":[{"measurements":[{"groupId":"OG000","value":"2.24","spread":"1.279"},{"groupId":"OG001","value":"5.39","spread":"1.273"},{"groupId":"OG002","value":"7.55","spread":"1.285"},{"groupId":"OG003","value":"3.34","spread":"1.289"}]}]},{"title":"Week 4 (n=135,132,135,128)","categories":[{"measurements":[{"groupId":"OG000","value":"5.10","spread":"1.354"},{"groupId":"OG001","value":"7.77","spread":"1.364"},{"groupId":"OG002","value":"9.35","spread":"1.356"},{"groupId":"OG003","value":"6.92","spread":"1.385"}]}]},{"title":"Week 8 (n=129,129,128,122)","categories":[{"measurements":[{"groupId":"OG000","value":"8.77","spread":"1.407"},{"groupId":"OG001","value":"9.59","spread":"1.408"},{"groupId":"OG002","value":"12.31","spread":"1.411"},{"groupId":"OG003","value":"11.28","spread":"1.441"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2, 4 and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138, 139, 136, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"0.74","spread":"1.511"},{"groupId":"OG001","value":"6.09","spread":"1.505"},{"groupId":"OG002","value":"7.38","spread":"1.520"},{"groupId":"OG003","value":"5.00","spread":"1.525"}]}]},{"title":"Week 4 (n=135, 132, 135, 128)","categories":[{"measurements":[{"groupId":"OG000","value":"4.53","spread":"1.706"},{"groupId":"OG001","value":"10.62","spread":"1.721"},{"groupId":"OG002","value":"12.97","spread":"1.709"},{"groupId":"OG003","value":"8.28","spread":"1.748"}]}]},{"title":"Week 8 (n=129, 129, 128, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"8.46","spread":"1.830"},{"groupId":"OG001","value":"14.09","spread":"1.833"},{"groupId":"OG002","value":"15.64","spread":"1.835"},{"groupId":"OG003","value":"15.76","spread":"1.878"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2, 4 and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138, 139, 136, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"2.99","spread":"1.630"},{"groupId":"OG001","value":"5.06","spread":"1.624"},{"groupId":"OG002","value":"4.52","spread":"1.644"},{"groupId":"OG003","value":"7.22","spread":"1.644"}]}]},{"title":"Week 4 (n=135, 132, 135, 128)","categories":[{"measurements":[{"groupId":"OG000","value":"4.45","spread":"1.738"},{"groupId":"OG001","value":"5.33","spread":"1.752"},{"groupId":"OG002","value":"7.75","spread":"1.744"},{"groupId":"OG003","value":"10.66","spread":"1.778"}]}]},{"title":"Week 8 (n=129, 129, 128, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"7.17","spread":"1.920"},{"groupId":"OG001","value":"11.99","spread":"1.920"},{"groupId":"OG002","value":"9.63","spread":"1.928"},{"groupId":"OG003","value":"12.89","spread":"1.970"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2, 4 and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138, 139, 136, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"2.83","spread":"1.048"},{"groupId":"OG001","value":"5.54","spread":"1.044"},{"groupId":"OG002","value":"5.64","spread":"1.054"},{"groupId":"OG003","value":"5.47","spread":"1.056"}]}]},{"title":"Week 4 (n=135, 132, 135, 128)","categories":[{"measurements":[{"groupId":"OG000","value":"6.51","spread":"1.235"},{"groupId":"OG001","value":"8.98","spread":"1.245"},{"groupId":"OG002","value":"9.96","spread":"1.238"},{"groupId":"OG003","value":"10.99","spread":"1.263"}]}]},{"title":"Week 8 (n=129, 129, 128, 121)","categories":[{"measurements":[{"groupId":"OG000","value":"8.68","spread":"1.392"},{"groupId":"OG001","value":"12.46","spread":"1.395"},{"groupId":"OG002","value":"13.67","spread":"1.396"},{"groupId":"OG003","value":"13.87","spread":"1.429"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2, 4 and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138, 139, 136, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"5.97","spread":"1.199"},{"groupId":"OG001","value":"10.39","spread":"1.193"},{"groupId":"OG002","value":"8.83","spread":"1.205"},{"groupId":"OG003","value":"8.03","spread":"1.208"}]}]},{"title":"Week 4 (n=135, 132, 135, 128)","categories":[{"measurements":[{"groupId":"OG000","value":"12.06","spread":"1.523"},{"groupId":"OG001","value":"16.69","spread":"1.536"},{"groupId":"OG002","value":"16.04","spread":"1.526"},{"groupId":"OG003","value":"16.07","spread":"1.560"}]}]},{"title":"Week 8 (n=129, 129, 128, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"16.14","spread":"1.748"},{"groupId":"OG001","value":"22.34","spread":"1.752"},{"groupId":"OG002","value":"21.21","spread":"1.753"},{"groupId":"OG003","value":"24.17","spread":"1.793"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2 and 4","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138, 139, 136, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"6.38","spread":"1.479"},{"groupId":"OG001","value":"9.71","spread":"1.473"},{"groupId":"OG002","value":"12.02","spread":"1.486"},{"groupId":"OG003","value":"10.03","spread":"1.491"}]}]},{"title":"Week 4 (n=135, 132, 135, 128)","categories":[{"measurements":[{"groupId":"OG000","value":"12.34","spread":"1.760"},{"groupId":"OG001","value":"15.71","spread":"1.775"},{"groupId":"OG002","value":"18.57","spread":"1.762"},{"groupId":"OG003","value":"15.84","spread":"1.804"}]}]},{"title":"Week 8 (n=129, 129, 128, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"15.60","spread":"1.989"},{"groupId":"OG001","value":"21.71","spread":"1.991"},{"groupId":"OG002","value":"21.87","spread":"1.993"},{"groupId":"OG003","value":"24.94","spread":"2.040"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2, 4 and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138, 139, 136, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"6.84","spread":"1.570"},{"groupId":"OG001","value":"8.78","spread":"1.563"},{"groupId":"OG002","value":"10.87","spread":"1.579"},{"groupId":"OG003","value":"9.93","spread":"1.581"}]}]},{"title":"Week 4 (n=135, 132, 135, 128)","categories":[{"measurements":[{"groupId":"OG000","value":"12.05","spread":"1.755"},{"groupId":"OG001","value":"17.01","spread":"1.772"},{"groupId":"OG002","value":"18.08","spread":"1.758"},{"groupId":"OG003","value":"14.58","spread":"1.797"}]}]},{"title":"Week 8 (n=129, 129, 128, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"15.96","spread":"1.941"},{"groupId":"OG001","value":"23.06","spread":"1.946"},{"groupId":"OG002","value":"22.89","spread":"1.947"},{"groupId":"OG003","value":"24.71","spread":"1.990"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed","description":"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.","populationDescription":"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 2, 4 and 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"137"},{"groupId":"OG003","value":"136"}]}],"classes":[{"title":"Week 2 (n=138, 139, 136, 136)","categories":[{"measurements":[{"groupId":"OG000","value":"6.98","spread":"1.199"},{"groupId":"OG001","value":"10.62","spread":"1.192"},{"groupId":"OG002","value":"9.56","spread":"1.205"},{"groupId":"OG003","value":"10.26","spread":"1.207"}]}]},{"title":"Week 4 (n= 135, 132, 135, 128)","categories":[{"measurements":[{"groupId":"OG000","value":"13.06","spread":"1.418"},{"groupId":"OG001","value":"16.78","spread":"1.429"},{"groupId":"OG002","value":"16.56","spread":"1.421"},{"groupId":"OG003","value":"16.38","spread":"1.451"}]}]},{"title":"Week 8 (n=129, 129, 128, 122)","categories":[{"measurements":[{"groupId":"OG000","value":"16.28","spread":"1.625"},{"groupId":"OG001","value":"23.61","spread":"1.628"},{"groupId":"OG002","value":"22.24","spread":"1.631"},{"groupId":"OG003","value":"24.89","spread":"1.667"}]}]}]},{"type":"SECONDARY","title":"Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.","description":"Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.","populationDescription":"Full analysis set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks."},{"id":"OG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks."},{"id":"OG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"139"},{"groupId":"OG002","value":"139"},{"groupId":"OG003","value":"139"}]}],"classes":[{"title":"Baseline: Any resource use","categories":[{"measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"61"}]}]},{"title":"Baseline: Any hospitalization-related services","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"}]}]},{"title":"Baseline: Hospitalization related to depression","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"}]}]},{"title":"Baseline: Any sick leave","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"21"}]}]},{"title":"Baseline: Sick leave related to depression","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"18"}]}]},{"title":"Week 8: Any resource use","categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"25"},{"groupId":"OG003","value":"25"}]}]},{"title":"Week 8: Any hospitalization-related service","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}]},{"title":"Week 8: Hospitalization related to depression","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Week 8: Any sick leave","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"18"}]}]},{"title":"Week 8: Sick leave related to depression","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"14"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"Treatment-emergent adverse events are defined as adverse events whose onset occurred or intensity increased after the first dose of double-blind study drug through 30 days after permanent discontinuation of double-blind study drug.","description":"At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.","seriousNumAffected":2,"seriousNumAtRisk":140,"otherNumAffected":39,"otherNumAtRisk":140},{"id":"EG001","title":"Vortioxetine 1 mg","description":"Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.","seriousNumAffected":1,"seriousNumAtRisk":140,"otherNumAffected":36,"otherNumAtRisk":140},{"id":"EG002","title":"Vortioxetine 5 mg","description":"Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.","seriousNumAffected":1,"seriousNumAtRisk":140,"otherNumAffected":56,"otherNumAtRisk":140},{"id":"EG003","title":"Vortioxetine 10 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.","seriousNumAffected":2,"seriousNumAtRisk":139,"otherNumAffected":39,"otherNumAtRisk":139}],"seriousEvents":[{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":1,"numAtRisk":140},{"groupId":"EG003","numAffected":0,"numAtRisk":139}]},{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":0,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":0,"numAtRisk":140},{"groupId":"EG003","numAffected":0,"numAtRisk":139}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":0,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]},{"term":"Hypertensive crisis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":140},{"groupId":"EG001","numAffected":1,"numAtRisk":140},{"groupId":"EG002","numAffected":0,"numAtRisk":140},{"groupId":"EG003","numAffected":0,"numAtRisk":139}]}],"otherEvents":[{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":0,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]},{"term":"Vertigo","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140},{"groupId":"EG001","numAffected":3,"numAtRisk":140},{"groupId":"EG002","numAffected":4,"numAtRisk":140},{"groupId":"EG003","numAffected":3,"numAtRisk":139}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":140},{"groupId":"EG001","numAffected":11,"numAtRisk":140},{"groupId":"EG002","numAffected":22,"numAtRisk":140},{"groupId":"EG003","numAffected":18,"numAtRisk":139}]},{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":140},{"groupId":"EG001","numAffected":2,"numAtRisk":140},{"groupId":"EG002","numAffected":1,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":140},{"groupId":"EG001","numAffected":2,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":4,"numAtRisk":139}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":140},{"groupId":"EG001","numAffected":2,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":3,"numAtRisk":139}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140},{"groupId":"EG001","numAffected":2,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":140},{"groupId":"EG001","numAffected":3,"numAtRisk":140},{"groupId":"EG002","numAffected":5,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":140},{"groupId":"EG001","numAffected":5,"numAtRisk":140},{"groupId":"EG002","numAffected":7,"numAtRisk":140},{"groupId":"EG003","numAffected":3,"numAtRisk":139}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":140},{"groupId":"EG001","numAffected":2,"numAtRisk":140},{"groupId":"EG002","numAffected":5,"numAtRisk":140},{"groupId":"EG003","numAffected":2,"numAtRisk":139}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":140},{"groupId":"EG001","numAffected":2,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":140},{"groupId":"EG001","numAffected":9,"numAtRisk":140},{"groupId":"EG002","numAffected":16,"numAtRisk":140},{"groupId":"EG003","numAffected":7,"numAtRisk":139}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":140},{"groupId":"EG001","numAffected":1,"numAtRisk":140},{"groupId":"EG002","numAffected":5,"numAtRisk":140},{"groupId":"EG003","numAffected":9,"numAtRisk":139}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":140},{"groupId":"EG001","numAffected":1,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":3,"numAtRisk":139}]},{"term":"Sedation","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":0,"numAtRisk":139}]},{"term":"Restlessness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140},{"groupId":"EG001","numAffected":1,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":2,"numAtRisk":139}]},{"term":"Hyperhidrosis","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":3,"numAtRisk":140},{"groupId":"EG003","numAffected":2,"numAtRisk":139}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":140},{"groupId":"EG001","numAffected":0,"numAtRisk":140},{"groupId":"EG002","numAffected":1,"numAtRisk":140},{"groupId":"EG003","numAffected":1,"numAtRisk":139}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property."},"pointOfContact":{"title":"Medical Director, Clinical Science","organization":"Takeda","email":"clinicaltrialregistry@tpna.com","phone":"800-778-2860"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","removedCountries":["Croatia","Serbia"]},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078784","term":"Vortioxetine"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}