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

J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7):762-72. doi: 10.1097/00004583-200107000-00010.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Analysis of Variance
  • Antidepressive Agents, Tricyclic / therapeutic use
  • Depressive Disorder / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Imipramine / therapeutic use
  • Least-Squares Analysis
  • Male
  • Paroxetine / adverse effects
  • Paroxetine / pharmacology
  • Paroxetine / therapeutic use*
  • Serotonin Uptake Inhibitors / adverse effects
  • Serotonin Uptake Inhibitors / pharmacology
  • Serotonin Uptake Inhibitors / therapeutic use*

Substances

  • Antidepressive Agents, Tricyclic
  • Serotonin Uptake Inhibitors
  • Paroxetine
  • Imipramine