• M B Keller, N D Ryan, M Strober, R G Klein, S P Kutcher, B Birmaher, O R Hagino, H Koplewicz, G A Carlson, G N Clarke, G J Emslie, D Feinberg, B Geller, V Kusumakar, G Papatheodorou, W H Sack, M Sweeney, K D Wagner, E B Weller, N C Winters, R Oakes, and J P McCafferty.
• Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI 02906, USA.
• J Am Acad Child Adolesc Psychiatry. 2001 Jul 1;40(7):762-72.

ObjectiveTo compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression.MethodAfter a 7- to 14-day screening period, 275 adolescents with major depression began 8 weeks of double-blind paroxetine (20-40 mg), imipramine (gradual upward titration to 200-300 mg), or placebo. The two primary outcome measures were endpoint response (Hamilton Rating Scale for Depression [HAM-D] score < or = 8 or > or = 50% reduction in baseline HAM-D) and change from baseline HAM-D score. Other depression-related variables were (1) HAM-D depressed mood item; (2) depression item of the Schedule for Affective Disorders and Schizophrenia for Adolescents-Lifetime version (K-SADS-L); (3) Clinical Global Impression (CGI) improvement scores of 1 or 2; (4) nine-item depression subscale of K-SADS-L; and (5) mean CGI improvement scores.ResultsParoxetine demonstrated significantly greater improvement compared with placebo in HAM-D total score < or = 8, 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 parent- 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 did so because of adverse cardiovascular effects.ConclusionsParoxetine is generally well tolerated and effective for major depression in adolescents.

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