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A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

Published online by Cambridge University Press:  24 February 2011

Y. Panahi ,
B. Rezazadeh Moghaddam ,
A. Sahebkar ,
M. Abbasi Nazari ,
F. Beiraghdar ,
G. Karami  and
A. R. Saadat
Y. Panahi*
Affiliation:
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
B. Rezazadeh Moghaddam
Affiliation:
Department of Clinical Pharmacy, Faculty of Pharmacy, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
A. Sahebkar
Affiliation:
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran Cardiovascular Research Center, Avicenna Research Institute, Mashhad University of Medical Sciences (MUMS), Mashhad, Iran Biotechnology Research Center and School of Pharmacy, Mashhad University of Medical Sciences (MUMS), Mashhad, Iran
M. Abbasi Nazari
Affiliation:
Department of Clinical Pharmacy, Faculty of Pharmacy, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
F. Beiraghdar
Affiliation:
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
G. Karami
Affiliation:
Department of Psychiatry, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, Iran
A. R. Saadat
Affiliation:
Department of Internal Medicine, Baqiyatallah University of Medical Sciences, Tehran, Iran
*
*Address for correspondence: Dr Y. Panahi, Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Molla-Sadra Street, Tehran, PO Box 19945-581, Iran. (Email: [email protected])
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Abstract

Background

Unlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.

Method

Seventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.

Results

On both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.

Conclusions

The results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

Keywords

Combat-related PTSDpost-traumatic stress disorderrandomized controlled trialsertraline
Type
Original Articles
Information
Psychological Medicine , Volume 41 , Issue 10 , October 2011 , pp. 2159 - 2166
Copyright
Copyright © Cambridge University Press 2011

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