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

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

Research output: Contribution to journalArticle

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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
StatePublished - Jul 1 2003
Externally publishedYes

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Sertraline
Placebos
Anxiety
Observation
Diagnostic and Statistical Manual of Mental Disorders
Social Phobia
Therapeutics

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Liebowitz, M. R., DeMartinis, N. A., Weihs, K. L., Londborg, P. D., Smith, W. T., Chung, H., ... 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.

Efficacy of sertraline in severe generalized social anxiety disorder : Results of a double-blind, placebo-controlled study. / Liebowitz, Michael R.; DeMartinis, Nicholas A.; Weihs, Karen L; Londborg, Peter D.; Smith, Ward T.; Chung, Henry; Fayyad, Rana; Clary, Cathryn M.

In: Journal of Clinical Psychiatry, Vol. 64, No. 7, 01.07.2003, p. 785-792.

Research output: Contribution to journalArticle

Liebowitz, MR, DeMartinis, NA, Weihs, KL, Londborg, PD, Smith, WT, Chung, H, Fayyad, R & Clary, CM 2003, 'Efficacy of sertraline in severe generalized social anxiety disorder: Results of a double-blind, placebo-controlled study', Journal of Clinical Psychiatry, vol. 64, no. 7, pp. 785-792.
Liebowitz, Michael R. ; DeMartinis, Nicholas A. ; Weihs, Karen L ; Londborg, Peter D. ; Smith, Ward T. ; Chung, Henry ; Fayyad, Rana ; Clary, Cathryn M. / Efficacy of sertraline in severe generalized social anxiety disorder : Results of a double-blind, placebo-controlled study. In: Journal of Clinical Psychiatry. 2003 ; Vol. 64, No. 7. pp. 785-792.
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