Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder.
BACKGROUND
Posttraumatic stress disorder (PTSD) is a common illness associated with significant disability. Few large, placebo-controlled trials have been reported.


METHODS
Outpatients with a DSM-III-R diagnosis of moderate-to-severe PTSD were randomized to 12 weeks of double-blind treatment with either sertraline (N = 100) in flexible daily doses in the range of 50 to 200 mg or placebo (N = 108). Primary outcome measures consisted of the Clinician-Administered PTSD Scale (CAPS-2) total severity score, the patient-rated Impact of Event Scale (IES), and the Clinical Global Impression-Severity (CGI-S) and -Improvement (CGI-I) ratings.


RESULTS
Mixed-effects analyses found significantly steeper improvement slopes for sertraline compared with placebo on the CAPS-2 (t = 2.96, P =.003), the IES (t = 2.26, P =.02), the CGI-I score (t = 3.62, P<.001), and the CGI-S score (t = 4.40, P<.001). An intent-to-treat end-point analysis found a 60% responder rate for sertraline and a 38% responder rate for placebo (chi(2)(1) = 8.48, P =.004). Sertraline treatment was well tolerated, with a 9% discontinuation rate because of adverse events, compared with 5% for placebo. Adverse events that were significantly more common in subjects given sertraline compared with placebo consisted of insomnia (35% vs 22%), diarrhea (28% vs 11%), nausea (23% vs 11%), fatigue (13% vs 5%), and decreased appetite (12% vs 1%).


CONCLUSIONS
The results of the current study suggest that sertraline is a safe, well-tolerated, and significantly effective treatment for PTSD.
Davidson
J R
JR
Anxiety and Traumatic Stress Program, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA.
Rothbaum
B O
BO
van der Kolk
B A
BA
Sikes
C R
CR
Farfel
G M
GM
D000328:Adult; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005221:Fatigue / Q000139:chemically induced; D001068:Feeding and Eating Disorders / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced; D010919:Placebos; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline