BACKGROUND: Little is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder (PTSD) relapse. AIMS: To assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse. METHOD: 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.
RCT Entities:
BACKGROUND: Little is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder (PTSD) relapse. AIMS: To assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse. METHOD: 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.
Authors: Kathryn M Connor; Jonathan R T Davidson; Richard H Weisler; Wei Zhang; Kurian Abraham Journal: Psychopharmacology (Berl) Date: 2005-12-10 Impact factor: 4.530