Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder

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.