A 24-week randomized, double-blind, placebo-controlled study of escitalopram for the prevention of generalized social anxiety disorder.

Abstract

OBJECTIVE:

Escitalopram has proven efficacy in the short-term treatment of generalized social anxiety disorder (SAD). The present relapse prevention study investigated relapse rates during a 24-week, randomized, double-blind, placebo-controlled period in patients with generalized SAD who had responded to 12-week open-label treatment with escitalopram.

METHOD:

A total of 517 patients with a primary diagnosis of generalized SAD (per DSM-IV criteria) and a Liebowitz Social Anxiety Scale (LSAS) total score of > or = 70 received 12 weeks of open-label treatment with flexible doses (10-20 mg/day) of escitalopram. Of these patients, 371 responded (Clinical Global Impressions-Improvement scale [CGI-I] score of 1 or 2) and were randomly assigned to 24 weeks of double-blind treatment with escitalo-pram (10 or 20 mg/day) (N = 190) or placebo (N = 181), continuing with the dose level administered at the end of the open-label period. Relapse was defined as either an increase in LSAS total score of > or = 10 or withdrawal due to lack of efficacy, as judged by the investigator. The study was conducted from January 2001 to June 2002.

RESULTS:

Survival analysis of relapse and time to relapse showed a significant advantage for escitalopram compared to placebo (log-rank test: p < .001). The risk of relapse was 2.8 times higher for placebo-treated patients than for escitalopram-treated patients (p < .001), resulting in significantly fewer escitalopram-treated patients relapsing (22% vs. 50%), at both doses. Escitalopram was well tolerated during double-blind treatment of generalized SAD, and only 2.6% of the escitalopram-treated patients withdrew because of adverse events. The overall discontinuation rate, excluding relapses, was 13.2% for patients treated with escitalopram and 8.3% for patients treated with placebo.

CONCLUSION:

Escitalopram was effective and well tolerated in the long-term treatment of generalized SAD.

• Authors: Stuart A Montgomery, Rico Nil, Natalie Dürr-Pal, Henrik Loft, Jean-Philippe Boulenger
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 66 Issue 10 Pg. 1270-8 (Oct 2005) ISSN: 0160-6689 [Print] United States
• PMID: 16259540 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Serotonin Uptake Inhibitors
• Citalopram

Topics

• Adolescent
• Adult
• Aged
• Citalopram (therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Longitudinal Studies
• Male
• Middle Aged
• Patient Dropouts
• Phobic Disorders (drug therapy, prevention & control, psychology)
• Placebos
• Psychiatric Status Rating Scales
• Secondary Prevention
• Selective Serotonin Reuptake Inhibitors (therapeutic use)
• Survival Analysis
• Treatment Outcome