Sertraline Treatment for Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled Study 

Olga Brawman-Mintzer, M.D.; Rebecca G. Knapp, Ph.D.; Moira Rynn, M.D.; Rickey E. Carter, Ph.D.; and Karl Rickels, M.D. 

Objective: This study assessed the efficacy and safety of sertraline in the treatment of generalized anxiety disorder (GAD).

Method: The study was conducted from April 2000 to May 2002. Outpatients with DSM-IV GAD (N = 326) who satisfied inclusion/exclusion criteria and completed a 1-week screening phase were randomly assigned to 10-week double-blind treatment with flexible dosing of sertraline (50-200 mg/day) or placebo. The primary efficacy measure was change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score. Response was defined as a 50% or greater decrease in HAM-A total score at endpoint.

Results: Sertraline produced a statistically significant reduction in anxiety symptoms, as measured by HAM-A total change scores (p = .032), HAM-A psychic anxiety subscale (p = .011), and Hospital Anxiety and Depression Scale-anxiety subscale (p = .001). Response rates were significantly higher (p = .05) for the sertraline group (59.2%) compared to the placebo group (48.2%). Sertraline was well tolerated, with only sexual side effects reported significantly more often by subjects receiving sertraline than those receiving placebo.

Conclusion: Despite the relatively small between-group differences, study findings suggest a role for sertraline in the acute treatment of GAD.

(J Clin Psychiatry 2006;67:874-881)

Received Sept. 27, 2005; accepted Jan. 30, 2006. From the Department of Psychiatry and Behavioral Sciences (Dr. Brawman-Mintzer) and the Department of Biostatistics, Bioinformatics, and Epidemiology (Drs. Knapp and Carter), Medical University of South Carolina, Charleston; the Ralph H. Johnson VA Medical Center, Charleston, S.C. (Dr. Brawman-Mintzer); and the Department of Psychiatry, University of Pennsylvania, Philadelphia (Drs. Rynn and Rickels).

This study was conducted with the support of an unrestricted investigator-initiated grant from Pfizer Inc, New York, N.Y.

Presented in part at the 15th European College of Neuropsychopharmacology (ECNP) Congress, Barcelona, Spain, October 5-9, 2002.

Financial disclosure appears at the end of the article.

Acknowledgments appear at the end of the article.

Corresponding author and reprints: Olga Brawman-Mintzer, M.D., Medical University of South Carolina, 5900 Core Rd., Suite 203, Charleston, SC 29406 (e-mail: mintzero@musc.edu).