Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial.
KELLER, MARTIN B. M.D.; RYAN, NEAL D. M.D.; STROBER, MICHAEL PH.D.; KLEIN, RACHEL G. PH.D.; KUTCHER, STAN P. M.D.; BIRMAHER, BORIS M.D.; HAGINO, OWEN R. M.D.; KOPLEWICZ, HAROLD M.D.; CARLSON, GABRIELLE A. M.D.; CLARKE, GREGORY N. PH.D.; EMSLIE, GRAHAM J. M.D.; FEINBERG, DAVID M.D.; GELLER, BARBARA M.D.; KUSUMAKAR, VIVEK M.D.; PAPATHEODOROU, GEORGE M.D.; SACK, WILLIAM H. M.D.; SWEENEY, MICHAEL PH.D.; WAGNER, KAREN DINEEN M.D., PH.D.; WELLER, ELIZABETH B. M.D.; WINTERS, NANCY C. M.D.; OAKES, ROSEMARY M.S.; MCCAFFERTY, JAMES P. B.S.
Journal of the American Academy of Child & Adolescent Psychiatry.
40(7):762-772, July 2001.
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Objective: To compare paroxetine with placebo and imipramine with placebo for the treatment of adolescent depression.
Method: After 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 <=8 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.
Results: Paroxetine demonstrated significantly greater improvement compared with placebo in HAM-D total score <=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.
Conclusions: Paroxetine is generally well tolerated and effective for major depression in adolescents.
Copyright 2001 (C) American Academy of Child and Adolescent Psychiatry