title: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Escitalopram was effective and well tolerated in the long-term treatment of generalized SAD.
authors.affiliation: Imperial College, London, UK. Stuart@samontgomery.co.uk
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Montgomery
authors.forename: Rico
authors.initials: R
authors.lastname: Nil
authors.forename: Natalie
authors.initials: N
authors.lastname: Dürr-Pal
authors.forename: Henrik
authors.initials: H
authors.lastname: Loft
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Boulenger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015283:Citalopram / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D010698:Phobic Disorders / Q000188:drug therapy* / Q000517:prevention & control / Q000523:psychology; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D015283:Citalopram; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors