Sertraline treatment for generalized anxiety disorder: a randomized, double-blind, placebo-controlled study.
OBJECTIVE
This study assessed the efficacy and safety of sertraline in the treatment of generalized anxiety disorder (GAD).


METHODS
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.


CONCLUSIONS
Despite the relatively small between-group differences, study findings suggest a role for sertraline in the acute treatment of GAD.
Brawman-Mintzer
Olga
O
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29406, USA. mintzero@musc.edu
Knapp
Rebecca G
RG
Rynn
Moira
M
Carter
Rickey E
RE
Rickels
Karl
K
D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline