Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial

Objective: To compare paroxetine with placebo and imipramine with placebo f or the treatment of adolescent depression. Method: After a 7- to 14-day scr eening period, 275 adolescents with major depression began 8 weeks of doubl e-blind paroxetine (20-40 mg), imipramine (gradual upward titration to 200- 300 mg), or placebo. The two primary outcome measures were endpoint respons e (Hamilton Rating Scale for Depression [HAM-D] score less than or equal to 8 or greater than or equal to 50% reduction in baseline HAM-D) and change f rom baseline HAM-D score. Other depression-related variables were (1) HAM-D depressed mood item; (2) depression item of the Schedule for Affective Dis orders and Schizophrenia for Adolescents-Lifetime version (K-SADS-L); (3) C linical Global impression (CGI) improvement scores of 1 or 2; (4) nine-item depression subscale of K-SADS-L; and (5) mean CGI improvement scores. Resu lts: Paroxetine demonstrated significantly greater improvement compared wit h placebo in HAM-D total score less than or equal to8, HAM-D depressed mood item, K-SADS-L depressed mood item, and CGI score of 1 or 2. The response to imipramine was not significantly different from placebo for any measure. Neither paroxetine nor imipramine differed significantly from placebo on p arent- or self-rating measures. Withdrawal rates for adverse effects were 9 .7% and 6.9% for paroxetine and placebo, respectively. Of 31.5% of subjects stopping imipramine therapy because of adverse effects, nearly one third d id so because of adverse cardiovascular effects. Conclusions: Paroxetine is generally well tolerated and effective for major depression in adolescents .