Efficacy of Sertraline in a 12-Week Trial for Generalized Anxiety Disorder

OBJECTIVE: Sertraline's efficacy and tolerability in treating generalized anxiety disorder were evaluated. METHOD: Adult outpatients with DSM-IV generalized anxiety disorder and a total score of 18 or higher on the Hamilton Anxiety Rating Scale were eligible. After a 1-week single-blind placebo...

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Bibliographic Details
Published in:	The American journal of psychiatry Vol. 161; no. 9; pp. 1642 - 1649
Main Authors:	Allgulander, Christer, Dahl, Alv A., Austin, Carol, Morris, Philip L.P., Sogaard, Jesper A., Fayyad, Rana, Kutcher, Stan P., Clary, Cathryn M.
Format:	Journal Article Conference Proceeding
Language:	English
Published:	Washington, DC American Psychiatric Publishing 01-09-2004 American Psychiatric Association
Subjects:	Adult Anxiety Disorders - drug therapy Anxiety Disorders - psychology Biological and medical sciences Clinical trials Double-Blind Method Drug Administration Schedule Female Humans Male Medical sciences Medical treatment Medicin och hälsovetenskap Mental depression Nausea - chemically induced Neuropharmacology Patients Pharmacology. Drug treatments Placebos Prescription drugs Psychiatric Status Rating Scales Psycholeptics: tranquillizer, neuroleptic Psychology. Psychoanalysis. Psychiatry Psychopharmacology Serotonin Uptake Inhibitors - adverse effects Serotonin Uptake Inhibitors - therapeutic use Sertraline - adverse effects Sertraline - therapeutic use Sleep Initiation and Maintenance Disorders - chemically induced Sweating - drug effects Treatment Outcome Human Serotonin Psychotropic Toxicity Treatment efficiency Anxiety disorder Reuptake inhibitor Sertraline Chemotherapy Treatment Tranquillizer Generalized anxiety disorder Antidepressant agent
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Summary:	OBJECTIVE: Sertraline's efficacy and tolerability in treating generalized anxiety disorder were evaluated. METHOD: Adult outpatients with DSM-IV generalized anxiety disorder and a total score of 18 or higher on the Hamilton Anxiety Rating Scale were eligible. After a 1-week single-blind placebo lead-in, patients were randomly assigned to 12 weeks of double-blind treatment with placebo (N=188, mean baseline anxiety score=25) or flexible doses (50-150 mg day) of sertraline (N=182, mean anxiety score=25). The primary outcome measure was baseline-to-endpoint change in the Hamilton anxiety scale total score. A secondary efficacy measure was the Clinical Global Impression (CGI) improvement score; response was defined as a score of 2 or less. RESULTS: Sertraline patients had significantly greater improvement than placebo patients on all efficacy measures at week 4. Analysis of covariance of the intent-to-treat group at endpoint (with the last observation carried forward) showed a significant difference in the decrease from baseline of the least-square mean total score on the Hamilton anxiety scale between sertraline (mean=11.7) and placebo (mean=8.0). Significantly greater endpoint improvement with sertraline than placebo was obtained for mean scores on the Hamilton anxiety scale psychic factor (6.7 versus 4.1) and somatic factor (5.0 versus 3.9). The rate of responders, based on CGI improvement and last observation carried forward, was significantly higher for sertraline (63%) than placebo (37%). Sertraline was well tolerated; 8% of patients versus 10% for placebo dropped out because of adverse events. CONCLUSIONS: Sertraline appears to be efficacious and well tolerated in the treatment of generalized anxiety disorder.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0002-953X 1535-7228
DOI:	10.1176/appi.ajp.161.9.1642