[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100219113":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":25,"studyPopulation":13,"armGroups":26,"interventions":38,"overallOfficials":48,"centralContacts":52,"locations":13,"responsibleParty":58,"collaborators":13,"id":60,"slug":13,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":13,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":13,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":80,"whyStopped":13,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":13},{"fullName":5,"class":6},"Bausch Health Americas, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Mean change from Baseline to EOT in total CDRS-R (raw) score","Change from Baseline to EOT in total Children's Depression Rating Scale - Revised (CDRS-R). A higher score indicates a more profound state of depression. The interviewer rates 17 symptom areas; the symptom scores are summed to generate a total score. The total score ranges from 17 to 108.","Baseline and 2 years",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","* The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.\n* The secondary efficacy endpoints include:\n\n  * Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)\n  * Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score \\\u003C29)\n  * Mean change from Baseline to EOT in CGI-C.\n\nSafety endpoints include:\n\n* Incidence of AEs\n* Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG\n* Treatment discontinuation due to AEs\n* Suicidality as assessed by the C-SSRS score\n* Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"bupropion hydrobromide","EXPERIMENTAL","study drug",[32],"Drug: bupropion hydrobromide",{"label":34,"type":35,"description":34,"interventionNames":36},"placebo","PLACEBO_COMPARATOR",[37],"Drug: Placebo",[39,44],{"type":40,"name":28,"description":30,"armGroupLabels":41,"otherNames":42},"DRUG",[28],[43],"Aplenzin",{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"Placebo","placebo arm",[34],[49],{"name":50,"affiliation":5,"role":51},"Varsha Bhatt","STUDY_DIRECTOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":13,"email":57},"Jessica Ferrigno","CONTACT","520-246-8205","jessica.ferrigno@bauschhealth.com",{"type":59,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100219113",false,"NCT02129751","Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder","A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder","Inclusion Criteria:\n\n* Male or female outpatients aged ≥7 to \\\u003C18 years (at Screening Visit 1).\n* Provide assent (subject) and written informed consent (parent\u002Flegal representative) and Health Insurance Portability and Accountability Act (HIPAA) for study participation (at Screening Visit 1).\n* Meet diagnostic criteria for MDD as defined in the DSM IV-TR5 at Screening Visits 1 and 1a (K-SADS-PL; see Appendix 17.2).\n* Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1).\n* Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3).\n* CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4).\n\nExclusion Criteria:\n\n* are unable to swallow medications without difficulty\n* have known hypersensitivity to bupropion hydrobromide\n* are pregnant or planning to get pregnant or are lactating\n* Women of childbearing age unable to use at least one method of effective contraception for the duration of the study\n* Previous history of attempted suicide\n* are unable to understand and communicate effectively with parent, Investigator, and study coordinator\n* are at immediate risk of requiring hospitalization, in the Investigator's opinion\n* have current seizure disorder or history of seizures or head trauma\n* have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities\n* have ECG or physical examination abnormality at screening\n* have body weight less than the 3rd percentile or greater than the 97th percentile for age.","ALL","7 Years","17 Years",{"count":70,"type":71},246,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety",[77],"Major Depressive Disorder",[79,28],"able to swallow medications without difficulty","NOT_YET_RECRUITING","2025-09-11",{"date":83,"type":84},"2025-09-17","ACTUAL",{"date":86,"type":71},"2026-06",{"date":88,"type":71},"2029-12",{"name":5,"class":6}]