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Wagner KD, Berard R, Stein MB, et al. A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial ofParoxetine in Children and Adolescents With Social Anxiety Disorder. Arch Gen Psychiatry. 2004;61(11):1153–1162. doi:10.1001/archpsyc.61.11.1153
Social anxiety disorder is a debilitating, highly prevalent disorder
in children and adolescents. If left untreated, it can interfere with emotional,
social, and school functioning.
To evaluate the efficacy and tolerability of paroxetine in children
and adolescents with social anxiety disorder.
Design and Setting
Multicenter, 16-week, randomized, double-blind, placebo-controlled,
flexible-dose, parallel-group, outpatient study.
A total of 322 children (8-11 years of age) and adolescents (12-17 years
of age) with social anxiety disorder as their predominant psychiatric illness.
Eligible patients were randomized (1:1) to receive paroxetine (10-50
mg/d) or placebo.
Four hundred twenty-five patients were screened, and 322 were randomized
to treatment. Of these, 319 were included in the intention-to-treat population
(paroxetine, n = 163; placebo, n = 156). At the week 16
last observation carried forward end point, the odds of responding (Clinical
Global Impression-Improvement score of 1 or 2) were statistically significantly
greater for paroxetine (77.6% response [125/161]) than for placebo (38.3%
response [59/154]) (adjusted odds ratio, 7.02; 95% confidence interval, 4.07
to 12.11; P<.001). The proportion of patients
who were “very much” improved (Clinical Global Impression-Improvement
score of 1) was 47.8% (77/161) for paroxetine compared with 14.9% (23/154)
for placebo. Adverse events occurring at an incidence of 5% or greater for
paroxetine and twice that for placebo were insomnia (14.1% vs 5.8%), decreased
appetite (8.0% vs 3.2%), and vomiting (6.7% vs 1.9%). Withdrawals due to adverse
events were infrequent (5.5% [9/163] for paroxetine and 1.3% [2/156] for placebo).
Paroxetine is an effective, generally well-tolerated treatment for pediatric
social anxiety disorder.
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