Efficacy of sertraline in severe generalized social anxiety disorder: results of a double-blind, placebo-controlled study.
BACKGROUND
Generalized social anxiety disorder is an early onset, highly chronic, frequently disabling disorder with a lifetime prevalence of approximately 13%. The goal of the current study was to evaluate the efficacy and tolerability of sertraline for the treatment of severe generalized social anxiety disorder in adults.


METHODS
After a 1-week single-blind placebo lead-in period, patients with DSM-IV generalized social phobia were randomly assigned to 12 weeks of double-blind treatment with flexible doses of sertraline (50-200 mg/day) or placebo. Primary efficacy outcomes were the mean change in the Liebowitz Social Anxiety Scale (LSAS) total score and the responder rate for the Clinical Global Impressions-Improvement scale (CGI-I), defined as a CGI-I score </= 2. Data were collected in 2000 and 2001.


RESULTS
211 patients were randomly assigned to sertraline (intent-to-treat [ITT] sample, 205), and 204 patients, to placebo (ITT sample, 196). At week 12, sertraline produced a significantly greater reduction in LSAS total score compared with placebo (mean last-observation-carried-forward [LOCF] change from baseline: -31.0 vs. -21.7; p =.001) and a greater proportion of responders (CGI-I score </= 2: 55.6% vs. 29% among week 12 completers and 46.8% vs. 25.5% in the ITT-LOCF sample; p <.001 for both comparisons). Sertraline was well tolerated, with 7.6% of patients discontinuing due to adverse events versus 2.9% of placebo-treated patients.


CONCLUSIONS
The results of the current study confirm the efficacy of sertraline in the treatment of severe social anxiety disorder.
Liebowitz
Michael R
MR
New York State Psychiatric Institute, New York, NY, USA. leibowitz@nyspi.cpmc.columbia.edu
DeMartinis
Nicholas A
NA
Weihs
Karen
K
Londborg
Peter D
PD
Smith
Ward T
WT
Chung
Henry
H
Fayyad
Rana
R
Clary
Cathryn M
CM
D000328:Adult; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D010549:Personal Satisfaction; D010698:Phobic Disorders / Q000175:diagnosis / Q000188:drug therapy*; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D020280:Sertraline / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline