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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

  • Y. Panahi (a1), B. Rezazadeh Moghaddam (a2), A. Sahebkar (a1) (a3) (a4), M. Abbasi Nazari (a2), F. Beiraghdar (a5), G. Karami (a6) and A. R. Saadat (a7)...

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.

Copyright

Corresponding author

*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: yunespanahi@yahoo.com)

References

Hide All
Boscarino, JA, Chang, J (1999). Electrocardiogram abnormalities among men with stress-related psychiatric disorders: implications for coronary heart disease and clinical research. Annals of Behavioral Medicine 21, 227234.
Brady, K, Pearlstein, T, Asnis, GM, Baker, D, Rothbaum, B, Sikes, CR, Farfel, GM (2000). Efficacy and safety of sertraline treatment of posttraumatic stress disorder: a randomized controlled trial. Journal of the American Medical Association 283, 18371844.
Chung, MY, Min, KH, Jun, YJ, Kim, SS, Kim, WC, Jun, EM (2004). Efficacy and tolerability of mirtazapine and sertraline in Korean veterans with posttraumatic stress disorder: a randomized open label trial. Human Psychopharmacology 19, 489494.
Creamer, M, Burgess, P, McFarlane, AC (2001). Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-Being. Psychological Medicine 31, 12371247.
Davidson, JR, Hughes, D, Blazer, DG, George, LK (1991). Post-traumatic stress disorder in the community: an epidemiological study. Psychological Medicine 21, 713721.
Davidson, JR, Rothbaum, BO, van der Kolk, BA, Sikes, CR, Farfel, GM (2001). Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder. Archives of General Psychiatry 58, 485492.
De Boer, M, Op den Velde, W, Falger, PJ, Hovens, JE, De Groen, JH, Van Duijn, H (1992). Fluvoxamine treatment for chronic PTSD: a pilot study. Psychotherapy and Psychosomatics 57, 158163.
Dow, B, Kline, N (1997). Antidepressant treatment of posttraumatic stress disorder and major depression in veterans. Annals of Clinical Psychiatry 9, 15.
Friedman, MJ (1997). Drug treatment for PTSD: answers and questions. Annals of the New York Academy of Sciences 821, 359371.
Friedman, MJ, Marmar, CR, Baker, DG, Sikes, CR, Farfel, GM (2007). Randomized, double-blind comparison of sertraline and placebo for posttraumatic stress disorder in a Department of Veterans Affairs setting. Journal of Clinical Psychiatry 68, 711720.
Hertzberg, MA, Feldman, ME, Beckham, JC, Kudler, HS, Davidson, JR (2000). Lack of efficacy for fluoxetine in PTSD: a placebo controlled trial in combat veterans. Annals of Clinical Psychiatry 12, 101105.
Kessler, RC (2000). Posttraumatic stress disorder: the burden to the individual and to society. Journal of Clinical Psychiatry 61, 4–12; discussion 13–14.
Kessler, RC, Sonnega, A, Bromet, E, Hughes, M, Nelson, CB (1995). Posttraumatic stress disorder in the National Comorbidity Survey. Archives of General Psychiatry 52, 10481060.
Marmar, CR, Schoenfeld, F, Weiss, DS, Metzler, T, Zatzick, D, Wu, R, Smiga, S, Tecott, L, Neylan, T (1996). Open trial of fluvoxamine treatment for combat-related posttraumatic stress disorder. Journal of Clinical Psychiatry 57, 6670; discussion 71–72.
Marshall, RD, Beebe, KL, Oldham, M, Zaninelli, R (2001). Efficacy and safety of paroxetine treatment for chronic PTSD: a fixed-dose, placebo-controlled study. American Journal of Psychiatry 158, 19821988.
Martenyi, F, Brown, EB, Zhang, H, Koke, SC, Prakash, A (2002 a). Fluoxetine v. placebo in prevention of relapse in post-traumatic stress disorder. British Journal of Psychiatry 181, 315320.
Martenyi, F, Brown, EB, Zhang, H, Prakash, A, Koke, SC (2002 b). Fluoxetine versus placebo in posttraumatic stress disorder. Journal of Clinical Psychiatry 63, 199206.
Martenyi, F, Soldatenkova, V (2006). Fluoxetine in the acute treatment and relapse prevention of combat-related post-traumatic stress disorder: analysis of the veteran group of a placebo-controlled, randomized clinical trial. European Neuropsychopharmacology 16, 340349.
Resnick, HS, Kilpatrick, DG, Dansky, BS, Saunders, BE, Best, CL (1993). Prevalence of civilian trauma and posttraumatic stress disorder in a representative national sample of women. Journal of Consulting and Clinical Psychology 61, 984991.
Tucker, P, Zaninelli, R, Yehuda, R, Ruggiero, L, Dillingham, K, Pitts, CD (2001). Paroxetine in the treatment of chronic posttraumatic stress disorder: results of a placebo-controlled, flexible-dosage trial. Journal of Clinical Psychiatry 62, 860868.
Ursano, RJ, Bell, C, Eth, S, Friedman, M, Norwood, A, Pfefferbaum, B, Pynoos, JD, Zatzick, DF, Benedek, DM, McIntyre, JS, Charles, SC, Altshuler, K, Cook, I, Cross, CD, Mellman, L, Moench, LA, Norquist, G, Twemlow, SW, Woods, S, Yager, J; Work Group on ASD and PTSD; Steering Committee on Practice Guidelines (2004). Practice guideline for the treatment of patients with acute stress disorder and posttraumatic stress disorder. American Journal of Psychiatry 161, 331.
Zatzick, DF, Marmar, CR, Weiss, DS, Browner, WS, Metzler, TJ, Golding, JM, Stewart, A, Schlenger, WE, Wells, KB (1997). Posttraumatic stress disorder and functioning and quality of life outcomes in a nationally representative sample of male Vietnam veterans. American Journal of Psychiatry 154, 16901695.
Zohar, J, Amital, D, Miodownik, C, Kotler, M, Bleich, A, Lane, RM, Austin, C (2002). Double-blind placebo-controlled pilot study of sertraline in military veterans with posttraumatic stress disorder. Journal of Clinical Psychopharmacology 22, 190195.

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