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Fluoxetine v. placebo in prevention of relapse in post-traumatic stress disorder

currently Novartis Pharmaceuticals, Basel, Switzerland

EILEEN B. BROWN, PhD, HARRY ZHANG, PhD, STEPHANIE C. KOKE, MS and APURVA PRAKASH, BA

Lilly Research Laboratories, Eli Lilly & Co., Indianapolis, Indiana, USA

Correspondence: Apurva Prakash, Lilly Research Laboratories, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, USA. Tel: (317) 277 8798; fax: (317) 277 9551

Declaration of interest This work was sponsored by Eli Lilly & Co.

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.

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ELIZABETH WALSH
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