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

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.