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The British Journal of Psychiatry (2002) 181: 315-320
© 2002 The Royal College of Psychiatrists

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

FERENC MARTENYI, MD

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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