Fluoxetine v. placebo in prevention of relapse in post-traumatic stress disorder.
BACKGROUND
Little is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder (PTSD) relapse.


OBJECTIVE
To assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse.


METHODS
This was a double-blind, randomised, placebo-controlled study. Following 12 weeks of acute treatment, patients who responded were rerandomised and continued in a 24-week relapse prevention phase with fluoxetine (n=69) or placebo (n=62). The primary efficacy assessment was the prevention of PTSD relapse, based on the time to relapse.


RESULTS
Patients in the fluoxetine/fluoxetine group were less likely to relapse than patients in the fluoxetine/placebo group (P=0.027). There were no clinically significant differences in treatment-emergent adverse events between treatment groups.


CONCLUSIONS
Fluoxetine is effective and well tolerated in the prevention of PTSD relapse for up to 6 months.
D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D055502:Secondary Prevention; D013313:Stress Disorders, Post-Traumatic / Q000517:prevention & control*
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine