Efficacy of sertraline in preventing relapse of posttraumatic stress disorder: Results of a 28-week double-blind, placebo-controlled study

objective: The study examined the efficacy of sertraline, compared with pla cebo, in sustaining improvement and preventing relapse over 28 weeks in pat ients with posttraumatic stress disorder (PTSD) who had completed a 12-week double-blind, placebo-controlled acute treatment study and a subsequent 24 -week open-label study of continuation treatment with sertraline. Method: Ninety-six patients were randomly assigned, in a double-blind desig n, to 28 weeks of maintenance treatment with sertraline (50-200 mg, N=46; 7 8% were women) or placebo (N=50; 62% were women). Measures used in biweekly assessments included the Clinician-Administered PTSD Scale, the Impact of Event Scale, and the Clinical Global Impression severity and improvement ra tings. Kaplan-Meier analyses were used to estimate time to discontinuation from the study due to relapse, relapse or study discontinuation due to clin ical deterioration, and acute exacerbation. Results: Continued treatment with sertraline yielded lower PTSD relapse rat es than placebo (5% versus 26%). Patients who received placebo were 6.4 tim es as likely to experience relapse as were patients who received sertraline . Kaplan-Meier analyses confirmed the protective effect of sertraline in si gnificantly extending time in remission. The ability of sertraline to susta in improvement was comparable across the three core PTSD symptom clusters ( reexperiencing/intrusion, avoidance/numbing, and hyperarousal). A regressio n analysis found early response during acute treatment to be associated wit h a more than 16-fold reduced risk of relapse after placebo substitution. S ertraline, at a mean endpoint dose of 137 mg, was well tolerated, with no s ertraline-related adverse events observed at a rate of 10% or higher. Conclusions: The results provide evidence for the ability of sertraline bot h to sustain improvement in PTSD symptoms and to provide prophylactic prote ction against relapse.