RT Journal
A1 Davidson JT, Rothbaum BO, van der Kolk BA, Sikes CR, Farfel GM
T1 MUlticenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder
JF Archives of General Psychiatry
JO Archives of General Psychiatry
YR 2001
FD May 1
VO 58
IS 5
SP 485
OP 492
DO 10.1001/archpsyc.58.5.485
UL http://dx.doi.org/10.1001/archpsyc.58.5.485
AB 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 (χ21 = 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%).Conclusion 
    The results of the current study suggest that sertraline is a safe, well-tolerated, and significantly effective treatment for PTSD.