{"protocolSection":{"identificationModule":{"nctId":"NCT01153009","orgStudyIdInfo":{"id":"LuAA21004_315"},"secondaryIdInfos":[{"id":"U1111-1114-8191","type":"REGISTRY","domain":"WHO"}],"organization":{"fullName":"Takeda","class":"INDUSTRY"},"briefTitle":"Safety and Efficacy of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder","officialTitle":"A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Duloxetine-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses (15 and 20 mg) of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-06"},"primaryCompletionDateStruct":{"date":"2012-03","type":"ACTUAL"},"completionDateStruct":{"date":"2012-03","type":"ACTUAL"},"studyFirstSubmitDate":"2010-06-28","studyFirstSubmitQcDate":"2010-06-28","studyFirstPostDateStruct":{"date":"2010-06-29","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"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults 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 614 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 15 mg\n* Vortioxetine 20 mg\n* Duloxetine 60 mg\n* Placebo (dummy inactive capsule) - 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-center trial was conducted in the United States. The overall time to participate in this study was up to 13 weeks. Participants made 9 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":["Depressive Disorder, Major"],"keywords":["Major Depressive Disorder","Depression","Melancholia","Drug Therapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":614,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks.","interventionNames":["Drug: Placebo"]},{"label":"Vortioxetine 15 mg","type":"EXPERIMENTAL","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.","interventionNames":["Drug: Vortioxetine"]},{"label":"Vortioxetine 20 mg","type":"EXPERIMENTAL","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.","interventionNames":["Drug: Vortioxetine"]},{"label":"Duloxetine 60 mg","type":"ACTIVE_COMPARATOR","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine","description":"Encapsulated vortioxetine immediate release tablets","armGroupLabels":["Vortioxetine 15 mg","Vortioxetine 20 mg"],"otherNames":["Lu AA21004","Brintellix®"]},{"type":"DRUG","name":"Duloxetine","description":"Overencapsulated duloxetine delayed-release capsules","armGroupLabels":["Duloxetine 60 mg"],"otherNames":["Cymbalta®"]},{"type":"DRUG","name":"Placebo","description":"Placebo-matching capsules","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). 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. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.","timeFrame":"Baseline and Week 8"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With a MADRS Response at Week 8","description":"Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. 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":"Baseline and Week 8"},{"measure":"Mean Clinical Global Impression Scale - Improvement (CGI-I) Score 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 were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.","timeFrame":"Week 8"},{"measure":"Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20","description":"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). 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) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.\n\nHAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity.","timeFrame":"Baseline and 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 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 were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.","timeFrame":"Baseline and Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Man or a woman who suffers from a major depressive episode (MDE) recurrent as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) as confirmed by the Structured Clinical Interview for DSM Disorders (SCID).\n2. The reported duration of the current MDE is at least 3 months.\n3. Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.\n4. Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.\n\nExclusion Criteria:\n\n1. Has previously participated in a Lu AA21004 clinical study.\n2. Has 1 or more the following:\n\n   1. Any current psychiatric disorder other than major depressive disorder (MDD) as defined in the DSM-IV-TR (as assessed by the SCID).\n   2. 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   3. Diagnosis of any substance abuse or dependence (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to screening (subject must also have negative urine drug screen prior to Baseline).\n   4. Presence or history of a clinically significant neurological disorder (including epilepsy).\n   5. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).\n   6. Any Axis II disorder that might compromise the study.\n3. The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.\n4. Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.\n5. Has clinically significant abnormal vital signs as determined by the investigator.\n6. Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.\n7. Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.\n8. Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those patients with basal cell or Stage I squamous cell carcinoma of the skin.\n9. Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.\n10. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.\n11. Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. The following are also considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.\n12. Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.","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":"Beverly Hills","state":"California","country":"United States","geoPoint":{"lat":34.07362,"lon":-118.40036}},{"city":"Chino","state":"California","country":"United States","geoPoint":{"lat":34.01223,"lon":-117.68894}},{"city":"Garden Grove","state":"California","country":"United States","geoPoint":{"lat":33.77391,"lon":-117.94145}},{"city":"Irvine","state":"California","country":"United States","geoPoint":{"lat":33.66946,"lon":-117.82311}},{"city":"Los 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Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26."},{"pmid":"31818787","type":"DERIVED","citation":"Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13."},{"pmid":"25575488","type":"DERIVED","citation":"Mahableshwarkar AR, Jacobsen PL, Chen Y, Serenko M, Trivedi MH. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD. Psychopharmacology (Berl). 2015 Jun;232(12):2061-70. doi: 10.1007/s00213-014-3839-0. Epub 2015 Jan 11."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 15 mg vortioxetine, 20 mg vortioxetine, or 60 mg duloxetine.","recruitmentDetails":"Participants took part in the study at 58 investigative sites in the United States from 22 June 2010 to 20 March 2012.","groups":[{"id":"FG000","title":"Placebo","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks."},{"id":"FG001","title":"Vortioxetine 15 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"FG002","title":"Vortioxetine 20 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"FG003","title":"Duloxetine 60 mg","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"161"},{"groupId":"FG001","numSubjects":"147"},{"groupId":"FG002","numSubjects":"154"},{"groupId":"FG003","numSubjects":"152"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"147"},{"groupId":"FG002","numSubjects":"154"},{"groupId":"FG003","numSubjects":"150"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"129"},{"groupId":"FG001","numSubjects":"113"},{"groupId":"FG002","numSubjects":"113"},{"groupId":"FG003","numSubjects":"115"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"41"},{"groupId":"FG003","numSubjects":"37"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"10"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Noncompliance with Study Medication","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Protocol Deviations","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"15"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks."},{"id":"BG001","title":"Vortioxetine 15 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"BG002","title":"Vortioxetine 20 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"BG003","title":"Duloxetine 60 mg","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"161"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"154"},{"groupId":"BG003","value":"152"},{"groupId":"BG004","value":"614"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42.4","spread":"12.55"},{"groupId":"BG001","value":"43.1","spread":"12.28"},{"groupId":"BG002","value":"42.8","spread":"12.40"},{"groupId":"BG003","value":"43.4","spread":"12.24"},{"groupId":"BG004","value":"42.9","spread":"12.35"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"≤55 years","categories":[{"measurements":[{"groupId":"BG000","value":"138"},{"groupId":"BG001","value":"125"},{"groupId":"BG002","value":"132"},{"groupId":"BG003","value":"126"},{"groupId":"BG004","value":"521"}]}]},{"title":">55 years","categories":[{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"26"},{"groupId":"BG004","value":"93"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"116"},{"groupId":"BG001","value":"104"},{"groupId":"BG002","value":"114"},{"groupId":"BG003","value":"119"},{"groupId":"BG004","value":"453"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"40"},{"groupId":"BG003","value":"33"},{"groupId":"BG004","value":"161"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Hispanic or Latino","categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"18"},{"groupId":"BG003","value":"23"},{"groupId":"BG004","value":"79"}]}]},{"title":"Non-Hispanic and non-Latino","categories":[{"measurements":[{"groupId":"BG000","value":"143"},{"groupId":"BG001","value":"127"},{"groupId":"BG002","value":"136"},{"groupId":"BG003","value":"129"},{"groupId":"BG004","value":"535"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Caucasian (or White, including Hispanic)","categories":[{"measurements":[{"groupId":"BG000","value":"122"},{"groupId":"BG001","value":"114"},{"groupId":"BG002","value":"115"},{"groupId":"BG003","value":"119"},{"groupId":"BG004","value":"470"}]}]},{"title":"Black","categories":[{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"36"},{"groupId":"BG003","value":"32"},{"groupId":"BG004","value":"136"}]}]},{"title":"American Indian or Alaska 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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":"31.6","spread":"4.18"},{"groupId":"BG001","value":"31.9","spread":"4.08"},{"groupId":"BG002","value":"32.0","spread":"4.36"},{"groupId":"BG003","value":"32.9","spread":"4.39"},{"groupId":"BG004","value":"32.1","spread":"4.27"}]}]}]},{"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 (absent) to 56 (maximum severity).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17.0","spread":"5.12"},{"groupId":"BG001","value":"17.5","spread":"5.28"},{"groupId":"BG002","value":"17.8","spread":"5.42"},{"groupId":"BG003","value":"18.4","spread":"5.81"},{"groupId":"BG004","value":"17.7","spread":"5.42"}]}]}]},{"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":"4.6","spread":"0.58"},{"groupId":"BG001","value":"4.5","spread":"0.55"},{"groupId":"BG002","value":"4.5","spread":"0.60"},{"groupId":"BG003","value":"4.5","spread":"0.60"},{"groupId":"BG004","value":"4.5","spread":"0.58"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). 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. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.","populationDescription":"The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid 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 and Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks."},{"id":"OG001","title":"Vortioxetine 15 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG002","title":"Vortioxetine 20 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG003","title":"Duloxetine 60 mg","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"113"},{"groupId":"OG002","value":"112"},{"groupId":"OG003","value":"115"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.83","spread":"0.834"},{"groupId":"OG001","value":"-14.30","spread":"0.890"},{"groupId":"OG002","value":"-15.57","spread":"0.880"},{"groupId":"OG003","value":"-16.90","spread":"0.884"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"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 15 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in a sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.224","pValueComment":"Pre-specified sequential statistical testing procedure indicates that when p-value \\>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.","paramType":"LS mean difference","paramValue":"-1.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.86","ciUpperLimit":"0.91","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.21"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.023","pValueComment":"Pre-specified sequential statistical testing procedure indicates that when p-value \\<0.025, hierarchical testing continues for this dose.","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"-2.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.12","ciUpperLimit":"-0.38","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.21"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"-4.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.46","ciUpperLimit":"-1.69","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.21"}]},{"type":"SECONDARY","title":"Percentage of Participants With a MADRS Response at Week 8","description":"Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. 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, last observation carried forward was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline and Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks."},{"id":"OG001","title":"Vortioxetine 15 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG002","title":"Vortioxetine 20 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG003","title":"Duloxetine 60 mg","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"145"},{"groupId":"OG002","value":"147"},{"groupId":"OG003","value":"146"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.2"},{"groupId":"OG001","value":"44.1"},{"groupId":"OG002","value":"44.2"},{"groupId":"OG003","value":"54.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.348","statisticalMethod":"Regression, Logistic","statisticalComment":"P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.249","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.786","ciUpperLimit":"1.984"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.332","pValueComment":"Pre-specified sequential statistical testing procedure indicates that when p-value \\>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.","statisticalMethod":"Regression, Logistic","statisticalComment":"P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.257","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.792","ciUpperLimit":"1.994"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","statisticalMethod":"Regression, Logistic","statisticalComment":"P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.991","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.250","ciUpperLimit":"3.171"}]},{"type":"SECONDARY","title":"Mean Clinical Global Impression Scale - Improvement (CGI-I) Score 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 were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.","populationDescription":"The 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":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks."},{"id":"OG001","title":"Vortioxetine 15 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG002","title":"Vortioxetine 20 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG003","title":"Duloxetine 60 mg","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"112"},{"groupId":"OG002","value":"111"},{"groupId":"OG003","value":"115"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.65","spread":"0.096"},{"groupId":"OG001","value":"2.54","spread":"0.102"},{"groupId":"OG002","value":"2.47","spread":"0.101"},{"groupId":"OG003","value":"2.31","spread":"0.101"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.400","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"-0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.39","ciUpperLimit":"0.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.140"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.177","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"-0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.139"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.014","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"-0.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.61","ciUpperLimit":"-0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.139"}]},{"type":"SECONDARY","title":"Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20","description":"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). 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) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.\n\nHAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity.","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 and Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks."},{"id":"OG001","title":"Vortioxetine 15 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG002","title":"Vortioxetine 20 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG003","title":"Duloxetine 60 mg","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-14.27","spread":"1.676"},{"groupId":"OG001","value":"-13.34","spread":"1.624"},{"groupId":"OG002","value":"-14.89","spread":"1.777"},{"groupId":"OG003","value":"-18.31","spread":"1.573"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.684","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"0.93","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.58","ciUpperLimit":"5.45","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.286"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.797","statisticalMethod":"Mixed model for repeated measurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"-0.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.40","ciUpperLimit":"4.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.419"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.078","statisticalMethod":"Mixed model for repeated mesurements","statisticalComment":"MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.","paramType":"LS Mean Difference","paramValue":"-4.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.54","ciUpperLimit":"0.45","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.278"}]},{"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, last observation carried forward was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Placebo","description":"Placebo-matching capsules, orally, once daily for up to 9 weeks."},{"id":"OG001","title":"Vortioxetine 15 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG002","title":"Vortioxetine 20 mg","description":"Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week."},{"id":"OG003","title":"Duloxetine 60 mg","description":"Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"145"},{"groupId":"OG002","value":"147"},{"groupId":"OG003","value":"146"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.8"},{"groupId":"OG001","value":"26.9"},{"groupId":"OG002","value":"29.3"},{"groupId":"OG003","value":"26.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.845","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.053","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.625","ciUpperLimit":"1.775"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.503","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.192","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.713","ciUpperLimit":"1.994"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.728","statisticalMethod":"Regression, Logistic","statisticalComment":"Logistic regression with explanatory variables for treatment and Baseline MADRS score.","paramType":"Odds Ratio (OR)","paramValue":"1.098","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.648","ciUpperLimit":"1.860"}]},{"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 were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.","populationDescription":"Full analysis set. 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