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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety

Detailed description

* 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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	bupropion hydrobromide	study drug
DRUG	Placebo	placebo arm

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-07-01
• Completion: 2029-12-01
• First posted: 2014-05-02
• Last updated: 2025-09-17

Regulatory

• FDA-regulated drug study