Efficacy of Sertraline in Severe Generalized Social Anxiety Disorder: Results of a Double-Blind, Placebo-Controlled Study
J Clin Psychiatry 2003;64(7):785-792
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Generalized social anxiety disorder
is an early onset, highly chronic, frequently disabling disorder
with a lifetime prevalence of approximately 13%. The goal of the
current study was to evaluate the efficacy and tolerability of
sertraline for the treatment of severe generalized social anxiety
disorder in adults.
Method: After a 1-week single-blind placebo
lead-in period, patients with DSM-IV generalized social phobia
were randomly assigned to 12 weeks of double-blind treatment with
flexible doses of sertraline (50-200 mg/day) or placebo. Primary
efficacy outcomes were the mean change in the Liebowitz Social
Anxiety Scale (LSAS) total score and the responder rate for the
Clinical Global Impressions-Improvement scale (CGI-I), defined as
a CGI-I score <= 2. Data were collected in 2000 and 2001.
Results: 211 patients were randomly assigned to
sertraline (intent-to-treat [ITT] sample, 205), and 204 patients,
to placebo (ITT sample, 196). At week 12, sertraline produced a
significantly greater reduction in LSAS total score compared with
placebo (mean last-observation-carried-forward [LOCF] change from
baseline: -31.0 vs. -21.7; p = .001) and a greater proportion of
responders (CGI-I score <= 2: 55.6% vs. 29% among week 12
completers and 46.8% vs. 25.5% in the ITT-LOCF sample; p <
.001 for both comparisons). Sertraline was well tolerated, with
7.6% of patients discontinuing due to adverse events versus 2.9%
of placebo-treated patients.