{"protocolSection":{"identificationModule":{"nctId":"NCT00707980","orgStudyIdInfo":{"id":"LuAA21004_301"},"secondaryIdInfos":[{"id":"2008-001581-91","type":"EUDRACT_NUMBER"},{"id":"U1111-1113-9564","type":"REGISTRY","domain":"WHO"},{"id":"2008","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2008"}],"organization":{"fullName":"Takeda","class":"INDUSTRY"},"briefTitle":"Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder","officialTitle":"A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-06"},"primaryCompletionDateStruct":{"date":"2010-07","type":"ACTUAL"},"completionDateStruct":{"date":"2010-08","type":"ACTUAL"},"studyFirstSubmitDate":"2008-06-27","studyFirstSubmitQcDate":"2008-07-01","studyFirstPostDateStruct":{"date":"2008-07-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-24","resultsFirstSubmitQcDate":"2013-10-24","resultsFirstPostDateStruct":{"date":"2013-12-13","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-10-24","lastUpdatePostDateStruct":{"date":"2013-12-13","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 long-term efficacy and safety of vortioxetine, once daily (QD), 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 people who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine.\n\nThe study enrolled 836 patients that had completed one of two other vortioxetine studies. Participants received 5 mg of vortioxetine for the first week of treatment. After completing the first week of treatment, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day based on participant's response as judged by the doctor.\n\nAll participants were asked to take one encapsulated tablet at the same time each day throughout the study.\n\nThis multi-center trial was conducted worldwide. The overall time to participate in this study was up to 56 weeks. Participants made 13 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":["Major Depressive Disorder","Depression","Melancholia","Mood Disorder","Dysthymic Disorder","Drug Therapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":836,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine","type":"EXPERIMENTAL","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.","interventionNames":["Drug: Vortioxetine"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine","description":"Encapsulated vortioxetine immediate-release tablets","armGroupLabels":["Vortioxetine"],"otherNames":["Lu AA21004","Brintellix®"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Physical Examination Findings","description":"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.\n\nEach system was assessed as normal or abnormal.","timeFrame":"Baseline and Week 52"},{"measure":"Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings","description":"Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.","timeFrame":"Weeks 4, 8, 12, 20, 28, 36, 44 and 52"},{"measure":"Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings","description":"A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval \\[QTc\\]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.","timeFrame":"Weeks 4, 12, 24, 36 and 52"},{"measure":"Number of Participants With Adverse Events (AEs)","description":"The intensity (severity) of each AE was defined as:\n\n* Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.\n* Moderate: sufficiently uncomfortable to produce some impairment of normal activities.\n* Severe: incapacitating, preventing the patient from participating in normal activities.\n\nThe causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion.","timeFrame":"From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)"},{"measure":"Number of Participants With Potentially Clinically Significant Vital Sign Findings","description":"Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.","timeFrame":"Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score","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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.","timeFrame":"Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52."},{"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 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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.","timeFrame":"Baseline and Weeks 4, 24 and 52"},{"measure":"Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score","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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.","timeFrame":"Baseline and Weeks 4, 24 and 52"},{"measure":"Change From Baseline in the Clinical Global Impression of Severity of Illness Scale","description":"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate 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. 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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.","timeFrame":"Baseline and Weeks 4, 24 and 52"},{"measure":"Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)","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 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst).","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline to the Final Visit in the Sheehan Disability Scale","description":"The Sheehan Disability Scale (SDS) 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.","timeFrame":"Baseline and Week 52"},{"measure":"Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire","description":"Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors 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 52"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Has completed the double blind treatment period of either study Lu AA21004\\_304 (NCT00672620) or LuAA21004\\_305 (NCT00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).\n* Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu AA21004\\_304 or Lu AA21004\\_305 study.\n\nExclusion Criteria:\n\n* In addition to meeting the exclusion criteria for studies Lu AA21004\\_304 or Lu AA21004\\_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:\n\n  * Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.\n  * The participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.\n  * The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.\n  * Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.\n  * Has used/uses disallowed concomitant medication.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"76 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":"Irvine","state":"California","country":"United States","geoPoint":{"lat":33.66946,"lon":-117.82311}},{"city":"Santa 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short-term efficacy and safety studies Lu AA21004\\_304 (NCT00672620) and LuAA21004\\_305 (NCT00735709) were eligible to receive the 52-week treatment with vortioxetine in this open-label extension study.","recruitmentDetails":"Participants took part in the study at 88 investigative sites in Australia, Croatia, France, Germany, Korea, Latvia, Lithuania, Malaysia, The Netherlands, Poland, Russia, Taiwan, Ukraine, and the United States from 17 June 2008 to 23 August 2010.","groups":[{"id":"FG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"836"}]},{"type":"Received Treatment","achievements":[{"groupId":"FG000","numSubjects":"834"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"526"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"310"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"49"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"35"}]},{"type":"Non-Compliance with Study Drug","reasons":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"Protocol Deviations","reasons":[{"groupId":"FG000","numSubjects":"19"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"81"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"59"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"39"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"836"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.5","spread":"12.78"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"≤55 years","categories":[{"measurements":[{"groupId":"BG000","value":"636"}]}]},{"title":">55 years","categories":[{"measurements":[{"groupId":"BG000","value":"200"}]}]}]},{"title":"Sex: Female, Male","description":"Note: Baseline refers to the open-label extension study baseline throughout these results.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"526"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"310"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Caucasian (White, including Hispanic)","categories":[{"measurements":[{"groupId":"BG000","value":"693"}]}]},{"title":"Black","categories":[{"measurements":[{"groupId":"BG000","value":"86"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"54"}]}]},{"title":"American Indian or Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}]},{"title":"Native Hawaiian/ Other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Race/Ethnicity, Customized","description":"Race data available for 836 participants.","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Hispanic/Latino","categories":[{"measurements":[{"groupId":"BG000","value":"53"}]}]},{"title":"Non-Hispanic/Non-Latino","categories":[{"measurements":[{"groupId":"BG000","value":"782"}]}]},{"title":"Missing","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"Australia","categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]},{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"207"}]}]},{"title":"France","categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}]},{"title":"Croatia","categories":[{"measurements":[{"groupId":"BG000","value":"11"}]}]},{"title":"Republic of Korea","categories":[{"measurements":[{"groupId":"BG000","value":"25"}]}]},{"title":"Lithuania","categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}]},{"title":"Latvia","categories":[{"measurements":[{"groupId":"BG000","value":"20"}]}]},{"title":"Malaysia","categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}]},{"title":"Netherlands","categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}]},{"title":"Poland","categories":[{"measurements":[{"groupId":"BG000","value":"57"}]}]},{"title":"Russia","categories":[{"measurements":[{"groupId":"BG000","value":"40"}]}]},{"title":"Taiwan","categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]},{"title":"Ukraine","categories":[{"measurements":[{"groupId":"BG000","value":"37"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"387"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"81.16","spread":"20.829"}]}]}]},{"title":"Height","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"169.00","spread":"9.777"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.41","spread":"7.074"}]}]}]},{"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":"17.6","spread":"9.40"}]}]}]},{"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":"16.6","spread":"9.24"}]}]}]},{"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":"12.1","spread":"7.17"}]}]}]},{"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":"3.2","spread":"1.26"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Physical Examination Findings","description":"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.\n\nEach system was assessed as normal or abnormal.","populationDescription":"The safety set included all participants who enrolled and received at least 1 dose of open-label study medication. Results include data for participants with available data at each time point; 834 participants at Baseline and 524 participants at Week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"834"}]}],"classes":[{"title":"Appearance at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"758"}]}]},{"title":"Appearance at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"76"}]}]},{"title":"Appearance at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"484"}]}]},{"title":"Appearance at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"40"}]}]},{"title":"Extremities at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"806"}]}]},{"title":"Extremities at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"28"}]}]},{"title":"Extremities at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"511"}]}]},{"title":"Extremities at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}]},{"title":"Skin at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"730"}]}]},{"title":"Skin at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"104"}]}]},{"title":"Skin at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"465"}]}]},{"title":"Skin at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"59"}]}]},{"title":"Head-Neck at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"822"}]}]},{"title":"Head-Neck at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]},{"title":"Head-Neck at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"518"}]}]},{"title":"Head-Neck at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"Eyes-Ears-Nose-Throat at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"772"}]}]},{"title":"Eyes-Ears-Nose-Throat at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"62"}]}]},{"title":"Eyes-Ears-Nose-Throat at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"485"}]}]},{"title":"Eyes-Ears-Nose-Throat at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"39"}]}]},{"title":"Lungs-Chest at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"827"}]}]},{"title":"Lungs-Chest at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]},{"title":"Lungs-Chest at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"523"}]}]},{"title":"Lungs-Chest at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Heart/Cardiovascular at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"816"}]}]},{"title":"Heart/Cardiovascular at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}]},{"title":"Heart/Cardiovascular at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"512"}]}]},{"title":"Heart/Cardiovascular at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]},{"title":"Abdomen at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"818"}]}]},{"title":"Abdomen at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]},{"title":"Abdomen at Baseline: Not done","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Abdomen at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"515"}]}]},{"title":"Abdomen at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}]},{"title":"Abdomen at Week 52: Not done","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Musculoskeletal at Baseline: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"790"}]}]},{"title":"Musculoskeletal at Baseline: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"44"}]}]},{"title":"Musculoskeletal at Week 52: Normal","categories":[{"measurements":[{"groupId":"OG000","value":"493"}]}]},{"title":"Musculoskeletal at Week 52: Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"31"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings","description":"Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.","populationDescription":"Safety set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Weeks 4, 8, 12, 20, 28, 36, 44 and 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"834"}]}],"classes":[{"title":"Alanine aminotransferase (ALT) ≥ 3 X ULN","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Aspartate aminotransferase (AST) ≥ 3 X ULN","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"Bilirubin ≥ 34.2 μmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Cholesterol ≥ 7.8 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"49"}]}]},{"title":"Creatine kinase ≥ 2 X ULN","categories":[{"measurements":[{"groupId":"OG000","value":"80"}]}]},{"title":"Creatinine ≥ 175 μmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Glucose ≤ 2.8 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]},{"title":"Glucose ≥ 13.9 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]},{"title":"High density lipoprotein cholesterol < 0.9 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"102"}]}]},{"title":"Low density lipoprotein cholesterol ≥ 5.0 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"69"}]}]},{"title":"Potassium ≤ 3.0 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Potassium ≥ 5.5 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}]},{"title":"Sodium ≤ 125 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Sodium ≥ 155 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Triglycerides ≥ 3.40 mmol/L","categories":[{"measurements":[{"groupId":"OG000","value":"168"}]}]},{"title":"Urate ≤ 0.7 X LLN","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Urate ≥ 1.3 XULN","categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]},{"title":"Eosinophils ≥ 0.6 10^9/L","categories":[{"measurements":[{"groupId":"OG000","value":"24"}]}]},{"title":"Erythrocytes ≤ 0.9 X LLN","categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]},{"title":"Erythrocytes ≥ 1.1 X ULN","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Hematocrit ≤ 0.9 X LLN","categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}]},{"title":"Hemoglobin ≤ 0.9 X LLN","categories":[{"measurements":[{"groupId":"OG000","value":"41"}]}]},{"title":"Leukocytes ≤ 2.8 X 10^9/L","categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}]},{"title":"Leukocytes ≥ 16 X 10^9/L","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Lymphocytes ≤ 0.6 X 10^9/L","categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]},{"title":"Lymphocytes ≥ 7 X 10^9/L","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Neutrophils ≤ 1.4 X 10^9/L","categories":[{"measurements":[{"groupId":"OG000","value":"26"}]}]},{"title":"Neutrophils ≥ 15 X 10^9/L","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings","description":"A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval \\[QTc\\]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.","populationDescription":"Safety set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Weeks 4, 12, 24, 36 and 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"834"}]}],"classes":[{"title":"Heart rate ≤50 bpm and change ≤-15bpm","categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]},{"title":"Heart rate ≥120 bpm and change ≥15 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"RR interval <500 msec and change ≤-200 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"RR interval >1200 msec and change ≥200 msec","categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}]},{"title":"PR interval <120 msec","categories":[{"measurements":[{"groupId":"OG000","value":"31"}]}]},{"title":"PR interval ≥250 msec","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"QT interval <280 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QT interval >500 msec","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"QTcB <340 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QTcB >500 msec","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"QTcB Change <-60 msec","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"QTcB Change >60 msec","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"QTcF <340 msec","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"QTcF >500 msec","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"QTcF Change <-60 msec","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"QTcF Change >60 msec","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Adverse Events (AEs)","description":"The intensity (severity) of each AE was defined as:\n\n* Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.\n* Moderate: sufficiently uncomfortable to produce some impairment of normal activities.\n* Severe: incapacitating, preventing the patient from participating in normal activities.\n\nThe causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion.","populationDescription":"Safety set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"834"}]}],"classes":[{"title":"Any adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"589"}]}]},{"title":"Related adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"413"}]}]},{"title":"Not related adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"176"}]}]},{"title":"Mild adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"187"}]}]},{"title":"Moderate adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"320"}]}]},{"title":"Severe adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"82"}]}]},{"title":"Adverse event leading to early termination","categories":[{"measurements":[{"groupId":"OG000","value":"50"}]}]},{"title":"Serious adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"29"}]}]},{"title":"Serious related adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]},{"title":"Serious not related adverse event","categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}]},{"title":"Serious adverse event leading to early termination","categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}]},{"title":"Deaths","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Potentially Clinically Significant Vital Sign Findings","description":"Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.","populationDescription":"Safety set","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"834"}]}],"classes":[{"title":"SSBP ≤90 mmHg and decrease of ≥20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]},{"title":"SSBP ≥180 mmHg and increase of ≥20 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"SDBP ≤50 mmHg and decrease of ≥15 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"SDBP ≥105 mmHg and increase of ≥15 mmHg","categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}]},{"title":"Supine pulse rate ≤50 bpm and decrease of ≥15 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]},{"title":"Supine pulse rate ≥120 bpm and increase of ≥15 bpm","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"Weight Change of ≥7% weight","categories":[{"measurements":[{"groupId":"OG000","value":"155"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score","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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.","populationDescription":"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"829"}]}],"classes":[{"title":"Week 1 (n=805)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.1","spread":"5.27"}]}]},{"title":"Week 2 (n=822)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.1","spread":"6.10"}]}]},{"title":"Week 4 (n=805)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.7","spread":"7.07"}]}]},{"title":"Week 8 (n=752)","categories":[{"measurements":[{"groupId":"OG000","value":"-6.5","spread":"7.43"}]}]},{"title":"Week 12 (n=715)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.0","spread":"8.27"}]}]},{"title":"Week 16 (n=671)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.7","spread":"8.45"}]}]},{"title":"Week 20 (n=639)","categories":[{"measurements":[{"groupId":"OG000","value":"-8.4","spread":"8.51"}]}]},{"title":"Week 24 (n=613)","categories":[{"measurements":[{"groupId":"OG000","value":"-8.3","spread":"8.92"}]}]},{"title":"Week 28 (n=599)","categories":[{"measurements":[{"groupId":"OG000","value":"-8.9","spread":"8.91"}]}]},{"title":"Week 36 (n=568)","categories":[{"measurements":[{"groupId":"OG000","value":"-9.3","spread":"9.05"}]}]},{"title":"Week 44 (n=540)","categories":[{"measurements":[{"groupId":"OG000","value":"-9.6","spread":"9.32"}]}]},{"title":"Week 52 (n=522)","categories":[{"measurements":[{"groupId":"OG000","value":"-10.0","spread":"8.86"}]}]},{"title":"Final Visit (n=829)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.9","spread":"9.66"}]}]}]},{"type":"SECONDARY","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 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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.","populationDescription":"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 4, 24 and 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"818"}]}],"classes":[{"title":"Week 4 (n=818)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.5","spread":"7.38"}]}]},{"title":"Week 24 (n=642)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.9","spread":"9.24"}]}]},{"title":"Week 52 (n=526)","categories":[{"measurements":[{"groupId":"OG000","value":"-9.5","spread":"8.90"}]}]},{"title":"Final Visit (n=818)","categories":[{"measurements":[{"groupId":"OG000","value":"-7.4","spread":"9.81"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score","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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.","populationDescription":"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. \"n\" indicates the number of patients included in the analysis at each time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Weeks 4, 24 and 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"818"}]}],"classes":[{"title":"Week 4 (n=818)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.9","spread":"5.12"}]}]},{"title":"Week 24 (n=642)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.1","spread":"6.44"}]}]},{"title":"Week 52 (n=527)","categories":[{"measurements":[{"groupId":"OG000","value":"-6.6","spread":"6.38"}]}]},{"title":"Final Visit (n= 818)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.2","spread":"6.76"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in the Clinical Global Impression of Severity of Illness Scale","description":"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate 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. 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For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"818"}]}],"classes":[{"title":"Week 4 (n=818)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.53","spread":"1.002"}]}]},{"title":"Week 24 (n=642)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.98","spread":"1.295"}]}]},{"title":"Week 52 (n= 527)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.33","spread":"1.266"}]}]},{"title":"Final Visit (n=818)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.00","spread":"1.338"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)","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. 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For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"824"}]}],"classes":[{"title":"Physical functioning subscore (n=824)","categories":[{"measurements":[{"groupId":"OG000","value":"4.5","spread":"15.88"}]}]},{"title":"Role-physical subscore (n=824)","categories":[{"measurements":[{"groupId":"OG000","value":"8.1","spread":"25.51"}]}]},{"title":"Bodily pain subscore (n=824)","categories":[{"measurements":[{"groupId":"OG000","value":"4.9","spread":"24.29"}]}]},{"title":"General health subscore (n=823)","categories":[{"measurements":[{"groupId":"OG000","value":"6.4","spread":"18.38"}]}]},{"title":"Vitality subscore (n=824)","categories":[{"measurements":[{"groupId":"OG000","value":"10.1","spread":"23.03"}]}]},{"title":"Social functioning subscore (n=824)","categories":[{"measurements":[{"groupId":"OG000","value":"10.9","spread":"26.90"}]}]},{"title":"Role-emotional subscore (n=824)","categories":[{"measurements":[{"groupId":"OG000","value":"12.3","spread":"28.24"}]}]},{"title":"Mental health subscore (n=824)","categories":[{"measurements":[{"groupId":"OG000","value":"10.7","spread":"22.04"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to the Final Visit in the Sheehan Disability Scale","description":"The Sheehan Disability Scale (SDS) 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.","populationDescription":"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"536"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.6","spread":"8.01"}]}]}]},{"type":"SECONDARY","title":"Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire","description":"Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors 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":"Safety set with available data","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine","description":"Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. 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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"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D019263","term":"Dysthymic Disorder"}],"ancestors":[{"id":"D001523","term":"Mental Disorders"},{"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}