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

Full Abstract

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 < 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. RESULTS: Paroxetine 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. CONCLUSIONS: Paroxetine is generally well tolerated and effective for major depression in adolescents.

Author information

Author/s: Keller, M B (MB); Ryan, N D (ND); Strober, M (M); Klein, R G (RG); Kutcher, S P (SP); Birmaher, B (B); Hagino, O R (OR); Koplewicz, H (H); Carlson, G A (GA); Clarke, G N (GN); Emslie, G J (GJ); Feinberg, D (D); Geller, B (B); Kusumakar, V (V); Papatheodorou, G (G); Sack, W H (WH); Sweeney, M (M); Wagner, K D (KD); Weller, E B (EB); Winters, N C (NC); Oakes, R (R); McCafferty, J P (JP);

Affiliation: Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI 02906, USA.

Journal and publication information

Publication Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Journal of the American Academy of Child and Adolescent Psychiatry (J Am Acad Child Adolesc Psychiatry), published in United States. (Language: eng)

Reference: 2001-Jul; vol 40 (issue 7) : pp 762-72

Dates: Created 2001/07/04; Completed 2001/08/02; Revised 2006/11/15;

PMID: 11437014, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: Evid Based Ment Health. 2002 Feb;5(1):16. (PMID: 11915819)

CommentIn: J Am Acad Child Adolesc Psychiatry. 2002 Apr;41(4):363-4; author reply 364. (PMID: 11931587)

CommentIn: J Am Acad Child Adolesc Psychiatry. 2002 Apr;41(4):364; author reply 364. (PMID: 11931589)

CommentIn: J Am Acad Child Adolesc Psychiatry. 2002 Nov;41(11):1269; author reply 1270. (PMID: 12410065)

CommentIn: J Am Acad Child Adolesc Psychiatry. 2002 Nov;41(11):1270; author reply 1271. (PMID: 12410066)

CommentIn: J Am Acad Child Adolesc Psychiatry. 2003 May;42(5):514; author reply 514-5. (PMID: 12707552)

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