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

• Published in: The journal of clinical psychiatry Vol. 66; no. 10; p. 1270
• Main Authors: Montgomery, Stuart A, Nil, Rico, Dürr-Pal, Natalie, Loft, Henrik, Boulenger, Jean-Philippe
• Format: Journal Article
• Language: English
• Published: United States 01.10.2005
• Subjects: 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; Phobic Disorders - prevention & control; Phobic Disorders - psychology; Placebos; Psychiatric Status Rating Scales; Secondary Prevention; Serotonin Uptake Inhibitors - therapeutic use; Survival Analysis; Treatment Outcome
• ISSN: 0160-6689
• DOI: 10.4088/jcp.v66n1009

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