Sertraline Treatment of Generalized Social Phobia: A 20-Week, Double-Blind, Placebo-Controlled Study

• Published in: The American journal of psychiatry 2001-02, Vol.158 (2), p.275-281
• Main Authors: Van Ameringen, Michael A., Lane, Roger M., Walker, John R., Bowen, Rudradeo C., Chokka, Pratap Rao, Goldner, Elliot M., Johnston, David G., Lavallee, Yvon-Jacques, Nandy, Saibal, Pecknold, John C., Hadrava, Vratislav, Swinson, Richard P.
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; Clinical trials; Diarrhea - chemically induced; Double blind studies; Double-Blind Method; Drug therapy; Fear & phobias; Female; Humans; Incidence; Male; Medical sciences; Middle Aged; Nausea - chemically induced; Neuropharmacology; Pharmacology. Drug treatments; Phobic Disorders - diagnosis; Phobic Disorders - drug therapy; Phobic Disorders - psychology; Placebos; Psychiatric Status Rating Scales - statistics & numerical data; Psychiatry; Psycholeptics: tranquillizer, neuroleptic; Psychology. Psychoanalysis. Psychiatry; Psychopharmacology; Serotonin reuptake inhibitors; Serotonin Uptake Inhibitors - adverse effects; Serotonin Uptake Inhibitors - therapeutic use; Sertraline - adverse effects; Sertraline - therapeutic use; Sleep Initiation and Maintenance Disorders - chemically induced; Social phobia; Treatment Outcome
• ISSN: 0002-953X; 1535-7228
• DOI: 10.1176/appi.ajp.158.2.275

OBJECTIVE: The authors evaluated the efficacy, safety, and tolerability of sertraline, a selective serotonin reuptake inhibitor, in the treatment of generalized social phobia. METHOD: Adult outpatients with generalized social phobia (N=204) from 10 Canadian centers were randomly assigned to receive sertraline or placebo in a 2:1 ratio for a 20-week double-blind study following a 1-week, single-blind, placebo run-in. The initial dose of sertraline was 50 mg day with increases of 50 mg day every 3 weeks permitted after the fourth week of treatment (dosing was flexible up to a maximum of 200 mg day). Primary efficacy assessments were the percentage of patients rated much or very much improved on the Clinical Global Impression (CGI) improvement item and the mean changes from baseline to study endpoint in total score on the social phobia subscale of the Marks Fear Questionnaire and total score on the Brief Social Phobia Scale. RESULTS: In intent-to-treat endpoint analyses of 203 of the patients, significantly more of the 134 patients given sertraline (N=71 [53%]) than of the 69 patients receiving placebo (N=20 [29%]) were considered responders according to their CGI improvement scores at the end of treatment. The mean reductions in the social phobia subscale of the Marks Fear Questionnaire and in the total score on the Brief Social Phobia Scale were 32.6% and 34.3% in the sertraline group and 10.8% and 18.6% in the placebo group, respectively. Analysis of covariance showed superiority of sertraline over placebo on all primary and secondary efficacy measures. Sertraline was well tolerated: 103 (76%) of the 135 sertraline-treated patients and 54 (78%) of the 69 placebo-treated patients completed the study. CONCLUSIONS: Sertraline is an effective treatment for patients with generalized social phobia.