Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety
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).
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
Single group
bupropion hydrobromide
Drugstudy drug
Placebo
Drugplacebo arm
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.
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