Efficacy of sertraline in severe generalized social anxiety disorder: Results of a double-blind, placebo-controlled study

Michael R. Liebowitz, Nicholas A. DeMartinis, Karen Weihs, Peter D. Londborg, Ward T. Smith, Henry Chung, Rana Fayyad, Cathryn M. Clary

Research output: Contribution to journalArticle

91 Scopus citations

Abstract

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. Conclusion: The results of the current study confirm the efficacy of sertraline in the treatment of severe social anxiety disorder.

Original languageEnglish (US)
Pages (from-to)785-792
Number of pages8
JournalJournal of Clinical Psychiatry
Volume64
Issue number7
DOIs
StatePublished - Jul 1 2003
Externally publishedYes

ASJC Scopus subject areas

  • Psychiatry and Mental health

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    Liebowitz, M. R., DeMartinis, N. A., Weihs, K., Londborg, P. D., Smith, W. T., Chung, H., Fayyad, R., & Clary, C. M. (2003). Efficacy of sertraline in severe generalized social anxiety disorder: Results of a double-blind, placebo-controlled study. Journal of Clinical Psychiatry, 64(7), 785-792. https://doi.org/10.4088/JCP.v64n0708