Objective: The aim of this study was to examine the efficacy, safety, and tolerability of paroxetine in adolescents with unipolar major depression. Method: Two hundred eighty-six (286) adolescents with unipolar major depression were randomly assigned to receive either paroxetine or placebo for 12 weeks. Results: The proportion of Montgomery-Åsberg Depression Rating Scale (MADRS) responders (at least 50% reduction from baseline) for paroxetine and placebo were similar and not statistically

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... ent at endpoint (p = 0.702). A similar result was obtained for change from baseline on the Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-L) depression subscale. Among secondary endpoints, only a significantly higher Clinical Global Impression-Improvement (CGI-I) response rate was reported in paroxetine-treated patients versus placebo (69.2% versus 57.3%; p = 0.045). In general, results differed by age, with patients older than 16 years demonstrating a greater response to active treatment. This age group also reported more adverse experiences (AEs) relative to placebo than younger adolescents. Overall, paroxetine was generally well tolerated (11% discontinued owing to an AE versus 7% of placebo-treated patients). A post hoc analysis of AEs related to suicidal behavior suggested a greater incidence of these events for paroxetine than for placebo (4.4% versus 2.1%); however, this difference was not statistically significant (odds ratio, 2.15, 95% Confidence Interval 0.45, 10.33; p = 0.502). Conclusions: No statistically significant differences were observed for paroxetine compared with placebo on the two prospectively defined primary efficacy variables. Paroxetine at 20-40 mg/day administered over a period of up to 12 weeks was generally well tolerated.