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

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.

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.