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Paxil fails to aid in major depression.

Paroxetine was no more effective than a placebo in reducing the symptoms of major depressive disorder in a population that, for the first time, included patients younger than 12 years, reported Dr. Graham J. Emslie of the University of Texas, Dallas, and his colleagues.

Overall, the average change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) was 22.58 points in patients who took paroxetine (Paxil) and -23.38 in a placebo group.

The randomized, double-blind, multi-center study of the effectiveness of paroxetine included an intent-to-treat population of 203 children aged 7-17 years who met the DSM-IV diagnostic criteria for major depressive disorder (J. Am. Acad. Child Adolesc Psychiatry 2006;45:709-19).

The patients received either 10-50 mg/kg paroxetine daily or placebo for 8 weeks. The average age at diagnosis was 10 years, and about hall of the patients in each group had experienced at least one prior major depressive disorder episode.

The dropout rate in the paroxetine group was significantly higher among children aged 7-11 years, compared with the placebo group (39% vs. 13%), which suggests a lower tolerance for the drug among younger children compared with adolescents. The overall dropout rate was not significantly different between the paroxetine and placebo groups.

Possible reasons for paroxetine's lack of efficacy include a lower average daily dosage compared with a previous adolescent-only study (20.4 mg/kg vs. 28 mg/kg) and a lower adherence rate in the treatment group compared with the placebo group, the researchers said.

The incidence of adverse events was similar and quite low in both groups, notably the incidence of suicidal behavior or suicidal ideation, which was 1.92% in the paroxetine group and 0.98% in the placebo group.

Paroxetine is not currently approved by the Food and Drug Administration for use by either children or adolescents. The study was sponsored by GlaxoSmithKline, manufacturer of Paxil, and Dr. Emslie has served as a paid consultant for the company.

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Title Annotation:Behavioral Pediatrics
Author:Splete, Heidi
Publication:Pediatric News
Geographic Code:1USA
Date:Jul 1, 2006
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