{"protocolSection":{"identificationModule":{"nctId":"NCT05014919","orgStudyIdInfo":{"id":"13546A"},"secondaryIdInfos":[{"id":"2010-020493-42","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"H. Lundbeck A/S","class":"INDUSTRY"},"briefTitle":"Vortioxetine to Prevent Return of Symptoms in Children With Depression","officialTitle":"A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2022-12","overallStatus":"TERMINATED","whyStopped":"The study was terminated based on new efficacy data from another study.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-08-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-03-31","type":"ACTUAL"},"completionDateStruct":{"date":"2022-04-28","type":"ACTUAL"},"studyFirstSubmitDate":"2021-08-16","studyFirstSubmitQcDate":"2021-08-16","studyFirstPostDateStruct":{"date":"2021-08-20","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-10-04","resultsFirstSubmitQcDate":"2022-12-12","resultsFirstPostDateStruct":{"date":"2023-01-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-12-12","lastUpdatePostDateStruct":{"date":"2023-01-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"H. Lundbeck A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.","detailedDescription":"The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.\n\nThe study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine."},"conditionsModule":{"conditions":["Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":35,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Vortioxetine -open label treatment period","type":"EXPERIMENTAL","description":"Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily.\n\nPatients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events.","interventionNames":["Drug: Vortioxetine"]},{"label":"Vortioxetine -double-blind relapse prevention period","type":"EXPERIMENTAL","description":"Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily.\n\nIn the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period","interventionNames":["Drug: Vortioxetine"]},{"label":"Placebo -double-blind relapse prevention period","type":"PLACEBO_COMPARATOR","description":"Placebo - encapsulated tablets, orally once daily.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Vortioxetine","description":"Tablets","armGroupLabels":["Vortioxetine -double-blind relapse prevention period","Vortioxetine -open label treatment period"],"otherNames":["Brintellix","Trintellix"]},{"type":"DRUG","name":"Placebo","description":"Tablets","armGroupLabels":["Placebo -double-blind relapse prevention period"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to Relapse in the Double-blind Period","description":"Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).","timeFrame":"From randomization to Week 26 in the double-blind treatment period"}],"secondaryOutcomes":[{"measure":"Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse","description":"Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).","timeFrame":"From randomization to Week 26 in the double-blind treatment period"},{"measure":"Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26","description":"The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26","description":"The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants).","timeFrame":"Baseline, Week 26"},{"measure":"Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26","description":"The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).","timeFrame":"Week 26"},{"measure":"Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26","description":"The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.","timeFrame":"Baseline, Week 26"},{"measure":"Plasma Concentration of Vortioxetine","timeFrame":"From randomization to Week 26 in the double-blind treatment period"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nDe novo participants\n\n* The participant has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).\n* The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.\n* The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit\n\nExclusion Criteria:\n\n* The participant receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.\n* The participant presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.\n* The participant has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.\n* The participant has attempted suicide or is at significant risk of suicide\n\nOther inclusion and exclusion criteria may apply.","healthyVolunteers":false,"sex":"ALL","minimumAge":"7 Years","maximumAge":"11 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Email contact via Lundbeck A/S","affiliation":"LundbeckClinicalTrials@Lundbeck.com","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Alliance for Research","city":"Long Beach","state":"California","zip":"90807","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"Atlanta Center for Medical Research","city":"Atlanta","state":"Georgia","zip":"30331","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"AIM Trials, LLC","city":"Plano","state":"Texas","zip":"75093","country":"United States","geoPoint":{"lat":33.01984,"lon":-96.69889}},{"facility":"Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.","city":"Barranquilla","state":"Atlántico","zip":"80020","country":"Colombia","geoPoint":{"lat":10.96854,"lon":-74.78132}},{"facility":"Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS","city":"Bogotá","state":"DC","zip":"111166","country":"Colombia","geoPoint":{"lat":4.60971,"lon":-74.08175}},{"facility":"Psynapsis Salud Mental S.A.","city":"Pereira","state":"Risaralda Department","zip":"660001","country":"Colombia","geoPoint":{"lat":4.81428,"lon":-75.69488}},{"facility":"Linda Keruze's Psychiatric Center, LLC","city":"Liepāja","zip":"3401","country":"Latvia","geoPoint":{"lat":56.50474,"lon":21.01085}},{"facility":"CRI Centro Regiomontano de Investigacion SC","city":"Monterrey","state":"Nuevo León","zip":"64060","country":"Mexico","geoPoint":{"lat":25.68435,"lon":-100.31721}},{"facility":"BIND Investigaciones S.C","city":"San Luis Potosí City","state":"San Luis Potosí","zip":"78213","country":"Mexico","geoPoint":{"lat":22.15234,"lon":-100.97135}},{"facility":"SINACOR - Centro para el Desarrollo de la Medicina Y De Asistencia Medica Especializada S.C","city":"Culiacan de Rosales","state":"Sinaloa","zip":"80230","country":"Mexico"},{"facility":"Przychodnia Syntonia Izabela Chojnowska-Cwiakala","city":"Kielce","zip":"25-103","country":"Poland","geoPoint":{"lat":50.87033,"lon":20.62752}},{"facility":"Indywidualna Specjalistyczna Praktyka Lekarska","city":"Poznan","zip":"60744","country":"Poland","geoPoint":{"lat":52.40692,"lon":16.92993}},{"facility":"Medicorehabilitation Research Center Phoenix","city":"Rostov-on-Don","state":"Rostov State","zip":"344010","country":"Russia","geoPoint":{"lat":47.21997,"lon":39.70769}},{"facility":"GUZ Engels Psychiatric Hospital","city":"Engel's","zip":"413124","country":"Russia","geoPoint":{"lat":51.48389,"lon":46.10528}},{"facility":"Rostov State Medical University of the Minzdravsotsrazvitiya of Russia","city":"Rostov-on-Don","zip":"344002","country":"Russia","geoPoint":{"lat":47.21997,"lon":39.70769}},{"facility":"Nebbiolo LLC","city":"Tomsk","zip":"634009","country":"Russia","geoPoint":{"lat":56.50049,"lon":84.98216}},{"facility":"Odessa Regional Psychiatry Hospital No. 2","city":"Odesa","zip":"65128","country":"Ukraine","geoPoint":{"lat":46.48572,"lon":30.74383}}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Rollover participants from Study 12709A enrolled to the open-label period and rollover participants (remitters) from Study 12712A randomized to the double-blind period. Overall, 35 participants were treated in this study: 33 participants in the open-label period (24 de novo participants and 9 rollover participants from Study 12709A) and 4 participants in the double-blind period (2 of whom rolled-over from Study 12712A).","recruitmentDetails":"The study population included de novo participants as well as rollover participants from other paediatric vortioxetine studies (Studies 12709A \\[NCT02709655\\] and 12712A \\[NCT02871297\\]) who, in the investigator's opinion, would benefit from continued treatment with vortioxetine.","groups":[{"id":"FG000","title":"Open-Label Treatment: Vortioxetine","description":"Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed."},{"id":"FG001","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"FG002","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"periods":[{"title":"Open-Label (12 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"24 de novo and 9 rollover participants","numSubjects":"33"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Based on Sponsor Information of Results From Vortioxetine Study","reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Study Terminated by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Double-Blind (26 Weeks)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","comment":"1 from open-label period and 1 from study 12712A","numSubjects":"2"},{"groupId":"FG002","comment":"1 from open-label period and 1 from study 12712A","numSubjects":"2"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Study Terminated by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Based on Sponsor Information of Results From Vortioxetine Study","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All-patients-enrolled (APES): all participants enrolled to the 12-week open-label treatment period who took at least 1 dose of study drug. Full analysis set (FAS): all participants randomized to the 26-week double-blind treatment period who took at least 1 dose of double-blind study drug.","groups":[{"id":"BG000","title":"Open-Label Treatment: Vortioxetine","description":"Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed."},{"id":"BG001","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"BG002","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"37"}]}],"measures":[{"title":"Age, Customized","populationDescription":"Data are being reported separately for the open-label and double-blind arms.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Open-Label Treatment","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"33"}]}],"categories":[{"title":"Children (2-11 years)","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"27"}]},{"title":"Adolescents (12-17 years)","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"6"}]}]},{"title":"Double-Blind Relapse Prevention","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}],"categories":[{"title":"Children (2-11 years)","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]},{"title":"Adolescents (12-17 years)","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Sex: Female, Male","populationDescription":"Data are being reported separately for the open-label and double-blind arms.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Open-Label Treatment","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"33"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"18"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"15"}]}]},{"title":"Double-Blind Relapse Prevention","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]}]}]},{"title":"Ethnicity (NIH/OMB)","populationDescription":"Data are being reported separately for the open-label and double-blind arms.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Open-Label Treatment","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"33"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"18"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"15"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]},{"title":"Double-Blind Relapse Prevention","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Race/Ethnicity, Customized","populationDescription":"Data are being reported separately for the open-label and double-blind arms.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Open-Label Treatment","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"33"}]}],"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"13"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"16"}]}]},{"title":"Double-Blind Relapse Prevention","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}],"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time to Relapse in the Double-blind Period","description":"Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).","populationDescription":"Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.","reportingStatus":"POSTED","timeFrame":"From randomization to Week 26 in the double-blind treatment period","groups":[{"id":"OG000","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"OG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse","description":"Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).","populationDescription":"Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.","reportingStatus":"POSTED","timeFrame":"From randomization to Week 26 in the double-blind treatment period","groups":[{"id":"OG000","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"OG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26","description":"The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).","populationDescription":"Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"OG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26","description":"The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants).","populationDescription":"Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"OG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26","description":"The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).","populationDescription":"Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"OG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26","description":"The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.","populationDescription":"Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 26","groups":[{"id":"OG000","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"OG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Plasma Concentration of Vortioxetine","populationDescription":"Due to early termination of the study, the pharmacokinetic analyses were not performed and the data were not collected.","reportingStatus":"POSTED","timeFrame":"From randomization to Week 26 in the double-blind treatment period","groups":[{"id":"OG000","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period."},{"id":"OG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"Baseline (Week 0) up to Week 42","description":"All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.","eventGroups":[{"id":"EG000","title":"Open-Label Treatment: Vortioxetine","description":"Participants initiated treatment with vortioxetine tablets 5 mg/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting AEs, vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.","deathsNumAffected":0,"deathsNumAtRisk":33,"seriousNumAffected":0,"seriousNumAtRisk":33,"otherNumAffected":8,"otherNumAtRisk":33},{"id":"EG001","title":"Double-Blind Relapse Prevention: Placebo","description":"Participants received placebo for 26 weeks in the double-blind relapse prevention period.","deathsNumAffected":0,"deathsNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"otherNumAffected":1,"otherNumAtRisk":2},{"id":"EG002","title":"Double-Blind Relapse Prevention: Vortioxetine","description":"Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.","deathsNumAffected":0,"deathsNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"otherNumAffected":0,"otherNumAtRisk":2}],"otherEvents":[{"term":"Food poisoning","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Coronavirus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Respiratory tract infection viral","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":33},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Electrocardiogram QT prolonged","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":33},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":2},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":2}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The study was terminated based on new efficacy data from another study. The main primary and secondary efficacy objectives were not assessed due to termination of the study and the limited number of participants who completed the double-blind period."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Email contact via","organization":"H. Lundbeck A/S","email":"LundbeckClinicalTrials@Lundbeck.com","phone":"+4536301311"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-01-07","uploadDate":"2022-10-04T07:59","filename":"Prot_000.pdf","size":856980},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2021-04-09","uploadDate":"2022-12-12T13:56","filename":"SAP_003.pdf","size":953544}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2022-10-28","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000078784","term":"Vortioxetine"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}