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

J Clin Psychiatry. 2003 Jul;64(7):785-92. doi: 10.4088/jcp.v64n0708.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Diagnostic and Statistical Manual of Mental Disorders
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Tolerance
  • Female
  • Humans
  • Male
  • Personal Satisfaction
  • Phobic Disorders / diagnosis
  • Phobic Disorders / drug therapy*
  • Quality of Life
  • Serotonin Uptake Inhibitors / administration & dosage
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Sertraline / administration & dosage
  • Sertraline / therapeutic use*
  • Severity of Illness Index
  • Single-Blind Method
  • Surveys and Questionnaires

Substances

  • Serotonin Uptake Inhibitors
  • Sertraline