A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
| Registry | NCT02129751 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, single group, masking: quadruple, treatment |
| Enrollment | 246 (Estimated) |
| Sponsor | Bausch Health Americas, Inc. (Industry) |
| Conditions | Major Depressive Disorder |
| Interventions | bupropion hydrobromide, Placebo (Drug) |
| Dates | start 2027-07-01 (estimated), primary completion 2030-07-01 (estimated), completion 2030-12-01 (estimated), first posted 2014-05-02, last updated 2026-09-29 |
Related Papers Related Patents Related Grants Related Experts
All trials for Major Depressive Disorder All trials of bupropion hydrobromide All trials of Placebo
Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety
* The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.
* The secondary efficacy endpoints include:
* Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)
* Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score <29)
* Mean change from Baseline to EOT in CGI-C.
Safety endpoints include:
* Incidence of AEs
* Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG
* Treatment discontinuation due to AEs
* Suicidality as assessed by the C-SSRS score
* Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| bupropion hydrobromide | Experimental | Drug: bupropion hydrobromide | study drug |
| placebo | Placebo comparator | Drug: Placebo | placebo |
Sex: All, ages: 7 Years to 17 Years
Inclusion Criteria: * Male or female outpatients aged ≥7 to <18 years (at Screening Visit 1). * Provide assent (subject) and written informed consent (parent/legal representative) and Health Insurance Portability and Accountability Act (HIPAA) for study participation (at Screening Visit 1). * 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). * Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1). * Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3). * CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4). Exclusion Criteria: * are unable to swallow medications without difficulty * have known hypersensitivity to bupropion hydrobromide * are pregnant or planning to get pregnant or are lactating * Women of childbearing age unable to use at least one method of effective contraception for the duration of the study * Previous history of attempted suicide * are unable to understand and communicate effectively with parent, Investigator, and study coordinator * are at immediate risk of requiring hospitalization, in the Investigator's opinion * have current seizure disorder or history of seizures or head trauma * have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities * have ECG or physical examination abnormality at screening * have body weight less than the 3rd percentile or greater than the 97th percentile for age.