{"protocolSection":{"identificationModule":{"nctId":"NCT01323478","orgStudyIdInfo":{"id":"13267B"},"secondaryIdInfos":[{"id":"2010-024198-38","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults","officialTitle":"A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2013-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-04"},"primaryCompletionDateStruct":{"date":"2012-09","type":"ACTUAL"},"completionDateStruct":{"date":"2012-10","type":"ACTUAL"},"studyFirstSubmitDate":"2011-03-24","studyFirstSubmitQcDate":"2011-03-24","studyFirstPostDateStruct":{"date":"2011-03-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-31","resultsFirstSubmitQcDate":"2013-12-23","resultsFirstPostDateStruct":{"date":"2014-02-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-12-23","lastUpdatePostDateStruct":{"date":"2014-02-11","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)"},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Depressive Disorder","Depression","Depressive Disorder, Major","Mood Disorders","Mental Disorders","Behavioural Symptoms"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":71,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine","type":"EXPERIMENTAL","interventionNames":["Drug: Vortioxetine (Lu AA21004)"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine (Lu AA21004)","description":"15 or 20 mg/day; tablets; orally","armGroupLabels":["Vortioxetine"],"otherNames":["Brintellix"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Patients With Adverse Events (AEs)","timeFrame":"Baseline to end of the 4-week safety follow-up period"},{"measure":"Percentage of Patients Who Withdrew Due to Intolerance to Treatment","timeFrame":"Baseline to Week 52"}],"secondaryOutcomes":[{"measure":"Change From Baseline in MADRS Total Score After 52 Weeks of Treatment","description":"The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in CGI-S Score After 52 Weeks of Treatment","description":"The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.","timeFrame":"Baseline and Week 52"},{"measure":"Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment","description":"The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.","timeFrame":"Baseline and Week 52"},{"measure":"Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)","timeFrame":"Baseline from lead-in study 13267A (NCT01140906) and Week 52"},{"measure":"Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)","timeFrame":"Baseline and Week 52"},{"measure":"SDS Total Score After 52 Weeks of Treatment","description":"The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.","timeFrame":"Week 52"},{"measure":"ASEX Total Score After 52 Weeks of Treatment","description":"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, \"How strong is your sex drive?\", \"Are your orgasms satisfying?\") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction.","timeFrame":"Week 52"},{"measure":"Risk of Suicidality Using C-SSRS Scores","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.","timeFrame":"Up to 52 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nPatients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study\n\nExclusion Criteria:\n\n* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR)\n* Female patients of childbearing potential who are not using effective contraception\n* Use of any psychoactive medication\n* The patient, in the investigator's clinical judgment, has a significant risk of suicide.\n\nOther protocol-defined inclusion and exclusion criteria applied.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Email contact via H. Lundbeck A/S","affiliation":"LundbeckClinicalTrials@lundbeck.com","role":"STUDY_DIRECTOR"}]},"referencesModule":{"references":[{"pmid":"36884024","type":"DERIVED","citation":"Mattingly GW, Necking O, Schmidt SN, Reines E, Ren H. Long-term safety and efficacy, including anhedonia, of vortioxetine for major depressive disorder: findings from two open-label studies. Curr Med Res Opin. 2023 Apr;39(4):613-619. doi: 10.1080/03007995.2023.2178082. Epub 2023 Mar 8."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study consisted of a 52-week open-label period and a 4-week Safety Follow-up Period.","recruitmentDetails":"Patients eligible to participate in Study 13267B were patients who had completed lead-in Study 13267A (NCT01140906) immediately prior to inclusion into present study, 13267B. The doses of Vortioxetine used in this long-term safety extension study were the same as those used in lead-in Study 13267A (NCT01140906).","groups":[{"id":"FG000","title":"Vortioxetine 15 or 20 mg/Day"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"71"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"47"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"7"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Non-compliance With Study Product","reasons":[{"groupId":"FG000","numSubjects":"3"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Withdrawal of Consent","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Administrative or Other Reasons","reasons":[{"groupId":"FG000","numSubjects":"8"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Age and Gender: all-patients-treated set (APTS) - all patients who took at least one dose of Vortioxetine.\n\nStudy Specific Characteristics: full-analysis set (FAS) - all 71 patients in the APTS who had at least one valid post-Baseline assessment of the MADRS total score in present study, 13267B.","groups":[{"id":"BG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"71"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.1","spread":"12.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"53"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"18"}]}]}]},{"title":"MADRS: Baseline present study, 13267B","description":"The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16.2","spread":"10.0"}]}]}]},{"title":"CGI-S: Baseline present study, 13267B","description":"The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.0","spread":"1.3"}]}]}]},{"title":"HAM-A: Baseline present study, 13267B","description":"The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11.9","spread":"6.6"}]}]}]},{"title":"MADRS: Baseline from lead-in study 13267A (NCT01140906)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31.1","spread":"3.3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Patients With Adverse Events (AEs)","populationDescription":"all-patients-treated set (APTS)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline to end of the 4-week safety follow-up period","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"}]}],"classes":[{"title":"Patients With AEs","categories":[{"measurements":[{"groupId":"OG000","value":"56"}]}]},{"title":"Patients With Serious AEs (SAEs)","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Patients With AEs Leading to Withdrawal","categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]}]},{"type":"PRIMARY","title":"Percentage of Patients Who Withdrew Due to Intolerance to Treatment","populationDescription":"APTS","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Baseline to Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.9"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in MADRS Total Score After 52 Weeks of Treatment","description":"The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.","populationDescription":"full-analysis set (FAS), observed cases (OC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.9","spread":"9.99"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in CGI-S Score After 52 Weeks of Treatment","description":"The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.","populationDescription":"FAS, OC","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.49","spread":"1.46"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment","description":"The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.","populationDescription":"FAS, OC","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.85","spread":"7.49"}]}]}]},{"type":"SECONDARY","title":"Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)","populationDescription":"FAS, OC","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Baseline from lead-in study 13267A (NCT01140906) and Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93.6"}]}]}]},{"type":"SECONDARY","title":"Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)","populationDescription":"FAS, OC","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Baseline and Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"80.9"}]}]}]},{"type":"SECONDARY","title":"SDS Total Score After 52 Weeks of Treatment","description":"The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.","populationDescription":"FAS, OC","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.85","spread":"5.84"}]}]}]},{"type":"SECONDARY","title":"ASEX Total Score After 52 Weeks of Treatment","description":"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, \"How strong is your sex drive?\", \"Are your orgasms satisfying?\") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction.","populationDescription":"APTS, OC","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Week 52","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18.60","spread":"0.96"}]}]}]},{"type":"SECONDARY","title":"Risk of Suicidality Using C-SSRS Scores","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.","populationDescription":"Suicidal Ideation and Behaviour Based on C-SSRS Scores by Columbia Classification Algorithm for Suicide Assessment (C-CASA) - APTS","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Up to 52 weeks","groups":[{"id":"OG000","title":"Vortioxetine 15 or 20 mg/Day"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"}]}],"classes":[{"title":"No suicidal ideation or behaviour","categories":[{"measurements":[{"groupId":"OG000","value":"67"}]}]},{"title":"Any non-suicidal self-injurious behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"Preparatory action towards imminent suicidal behav","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Not fatal suicide attempt","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Completed suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period","eventGroups":[{"id":"EG000","title":"Vortioxetine 15 or 20 mg/Day","seriousNumAffected":1,"seriousNumAtRisk":71,"otherNumAffected":47,"otherNumAtRisk":71}],"seriousEvents":[{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71}]}],"otherEvents":[{"term":"Abdominal pain upper","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":71}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":71}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":71}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":71}]},{"term":"Viral upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":71}]},{"term":"Accidental overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":71}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":71}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":71}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":71}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"The primary publication must be published before any secondary publications. H. Lundbeck A/S will ensure that the authorship of all publications based on this study is in accordance with the criteria defined by the International Committee of Medical Journal Editors (ICMJE)."},"pointOfContact":{"title":"H. Lundbeck A/S","organization":"H. Lundbeck A/S","email":"LundbeckClinicalTrials@lundbeck.com","phone":"+45 3630 1311"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","removedCountries":["Belgium","Estonia","Finland","Latvia","Norway","Slovakia","Sweden"]},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D003863","term":"Depression"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"}],"ancestors":[{"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}