Efficacy of paroxetine in the treatment of adolescent major depression

A randomized, controlled trial

Martin B. Keller, Neal D. Ryan, Michael Strober, Rachel G. Klein, Stan P. Kutcher, Boris Birmaher, Owen R. Hagino, Harold Koplewicz, Gabrielle A. Carlson, Gregory N. Clarke, Grahm J. Emslie, David Feinberg, Barbara Geller, Vivek Kusumakar, George Papatheodorou, William H. Sack, Michael Sweeney, Karen Dineen Wagner, Elizabeth B. Weller, Nancy C. Winters & 2 others Rosemary Oakes, James P. McCafferty

Research output: Contribution to journalArticle

484 Citations (Scopus)

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 ≤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.

Original languageEnglish (US)
Pages (from-to)762-772
Number of pages11
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume40
Issue number7
StatePublished - 2001

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Paroxetine
Imipramine
Randomized Controlled Trials
Placebos
Depression
Therapeutics
Mood Disorders
Schizophrenia
Appointments and Schedules
Outcome Assessment (Health Care)

Keywords

  • Adolescent
  • Imipramine
  • Major depression
  • Paroxetine

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

Keller, M. B., Ryan, N. D., Strober, M., Klein, R. G., Kutcher, S. P., Birmaher, B., ... McCafferty, J. P. (2001). Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry, 40(7), 762-772.

Efficacy of paroxetine in the treatment of adolescent major depression : A randomized, controlled trial. / Keller, Martin B.; Ryan, Neal D.; Strober, Michael; Klein, Rachel G.; Kutcher, Stan P.; Birmaher, Boris; Hagino, Owen R.; Koplewicz, Harold; Carlson, Gabrielle A.; Clarke, Gregory N.; Emslie, Grahm J.; Feinberg, David; Geller, Barbara; Kusumakar, Vivek; Papatheodorou, George; Sack, William H.; Sweeney, Michael; Wagner, Karen Dineen; Weller, Elizabeth B.; Winters, Nancy C.; Oakes, Rosemary; McCafferty, James P.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 40, No. 7, 2001, p. 762-772.

Research output: Contribution to journalArticle

Keller, MB, Ryan, ND, Strober, M, Klein, RG, Kutcher, SP, Birmaher, B, Hagino, OR, Koplewicz, H, Carlson, GA, Clarke, GN, Emslie, GJ, Feinberg, D, Geller, B, Kusumakar, V, Papatheodorou, G, Sack, WH, Sweeney, M, Wagner, KD, Weller, EB, Winters, NC, Oakes, R & McCafferty, JP 2001, 'Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial', Journal of the American Academy of Child and Adolescent Psychiatry, vol. 40, no. 7, pp. 762-772.
Keller, Martin B. ; Ryan, Neal D. ; Strober, Michael ; Klein, Rachel G. ; Kutcher, Stan P. ; Birmaher, Boris ; Hagino, Owen R. ; Koplewicz, Harold ; Carlson, Gabrielle A. ; Clarke, Gregory N. ; Emslie, Grahm J. ; Feinberg, David ; Geller, Barbara ; Kusumakar, Vivek ; Papatheodorou, George ; Sack, William H. ; Sweeney, Michael ; Wagner, Karen Dineen ; Weller, Elizabeth B. ; Winters, Nancy C. ; Oakes, Rosemary ; McCafferty, James P. / Efficacy of paroxetine in the treatment of adolescent major depression : A randomized, controlled trial. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2001 ; Vol. 40, No. 7. pp. 762-772.
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T1 - Efficacy of paroxetine in the treatment of adolescent major depression

T2 - A randomized, controlled trial

AU - Keller, Martin B.

AU - Ryan, Neal D.

AU - Strober, Michael

AU - Klein, Rachel G.

AU - Kutcher, Stan P.

AU - Birmaher, Boris

AU - Hagino, Owen R.

AU - Koplewicz, Harold

AU - Carlson, Gabrielle A.

AU - Clarke, Gregory N.

AU - Emslie, Grahm J.

AU - Feinberg, David

AU - Geller, Barbara

AU - Kusumakar, Vivek

AU - Papatheodorou, George

AU - Sack, William H.

AU - Sweeney, Michael

AU - Wagner, Karen Dineen

AU - Weller, Elizabeth B.

AU - Winters, Nancy C.

AU - Oakes, Rosemary

AU - McCafferty, James P.

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N2 - 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.

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