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.


METHODS
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.
Allgulander
Christer
C
Karolinska Institutet, Neurotec Department, Section of Psychiatry at Huddinge, University Hospital, 141 86 Huddinge, Sweden. Christer.Allgulander@neurotec.ki.se
Dahl
Alv A
AA
Austin
Carol
C
Morris
Philip L P
PL
Sogaard
Jesper A
JA
Fayyad
Rana
R
Kutcher
Stan P
SP
Clary
Cathryn M
CM
D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D013546:Sweating / Q000187:drug effects; D016896:Treatment Outcome
D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline