An international, multicenter, placebo-controlled trial of paroxetine in adolescents with major depressive disorder

J Child Adolesc Psychopharmacol. Feb-Apr 2006;16(1-2):59-75. doi: 10.1089/cap.2006.16.59.


Objective: The aim of this study was to examine the efficacy, safety, and tolerability of paroxetine in adolescents with unipolar major depression.

Method: Two hundred eighty-six (286) adolescents with unipolar major depression were randomly assigned to receive either paroxetine or placebo for 12 weeks.

Results: The proportion of Montgomery-Asberg Depression Rating Scale (MADRS) responders (at least 50% reduction from baseline) for paroxetine and placebo were similar and not statistically different at endpoint (p = 0.702). A similar result was obtained for change from baseline on the Kiddie-Schedule for Affective Disorders and Schizophrenia for School- Age Children (K-SADS-L) depression subscale. Among secondary endpoints, only a significantly higher Clinical Global Impression-Improvement (CGI-I) response rate was reported in paroxetine-treated patients versus placebo (69.2% versus 57.3%; p = 0.045). In general, results differed by age, with patients older than 16 years demonstrating a greater response to active treatment. This age group also reported more adverse experiences (AEs) relative to placebo than younger adolescents. Overall, paroxetine was generally well tolerated (11% discontinued owing to an AE versus 7% of placebo-treated patients). A post hoc analysis of AEs related to suicidal behavior suggested a greater incidence of these events for paroxetine than for placebo (4.4% versus 2.1%); however, this difference was not statistically significant (odds ratio, 2.15, 95% Confidence Interval 0.45, 10.33; p = 0.502).

Conclusions: No statistically significant differences were observed for paroxetine compared with placebo on the two prospectively defined primary efficacy variables. Paroxetine at 20-40 mg/day administered over a period of up to 12 weeks was generally well tolerated.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Depressive Disorder, Major / drug therapy*
  • Depressive Disorder, Major / psychology
  • Double-Blind Method
  • Female
  • Humans
  • Internationality*
  • Logistic Models
  • Male
  • Paroxetine / therapeutic use*
  • Prospective Studies
  • Single-Blind Method


  • Paroxetine