Healthy Skepticism Library item: 5007

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Publication type: Journal Article

Emslie GJ, Wagner KD, Kutcher S, Krulewicz S, Fong R, Carpenter DJ, Lipschitz A, Machin A, Wilkinson C.
Paroxetine Treatment in Children and Adolescents With Major Depressive Disorder: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial.
J Am Acad Child Adolesc Psychiatry 2006 Jun 01; 45:(6):709-719
http://meta.wkhealth.com/pt/pt-core/template-journal/lwwgateway/media/landingpage.htm?doi=10.1097/01.chi.0000214189.73240.63

Abstract:

OBJECTIVE:: To assess the efficacy and tolerability of paroxetine in pediatric major depressive disorder. METHOD:: Subjects 7 to 17 years old with major depressive disorder received paroxetine (10-50 mg/day) or placebo for 8 weeks from 2000 to 2001. The primary efficacy measure was change from baseline in the Children’s Depression Rating Scale-Revised total score at week 8 last observation carried forward). Safety was primarily assessed by spontaneous reporting of adverse events. RESULTS:: A total of 206 patients (intent to treat) were randomized to paroxetine (n = 104) or placebo (n = 102). Week 8 Children’s Depression Rating Scale-Revised total score adjusted mean changes from baseline for patients receiving paroxetine and placebo were -22.58 (SE 1.47) and -23.38 points (SE 1.60), respectively (0.80, 95% confidence interval -3.09 to 4.69, p = 0.684). Increased cough (5.9% versus 2.9%), dyspepsia (5.9% versus 2.9%), vomiting (5.9% versus 2.0%), and dizziness (5.0% versus 1.0%) occurred in >/=5% of the paroxetine group and at least twice that of the placebo group. Six of 104 (5.8%) paroxetine patients reported serious adverse events compared to 1 placebo patient (1.0%). The incidence of adverse events of suicidal behavior and/or ideation while taking study medication (excluding taper) was 1.92% (2/104) for paroxetine versus 0.98% (1/102) for placebo. CONCLUSIONS:: Paroxetine was not shown to be more efficacious than placebo for treating pediatric major depressive disorder.

Notes:

Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.