This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (140)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Post Traumatic Stress Disorder  • Stress  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

Jonathan R. T. Davidson, MD; Barbara O. Rothbaum, PhD; Bessel A. van der Kolk, MD; Carolyn R. Sikes, PhD; Gail M. Farfel, PhD

Arch Gen Psychiatry. 2001;58:485-492.

Background  Posttraumatic stress disorder (PTSD) is a common illness associated with significant disability. Few large, placebo-controlled trials have been reported.

Methods  Outpatients with a DSM-III-R diagnosis of moderate-to-severe PTSD were randomized to 12 weeks of double-blind treatment with either sertraline (N = 100) in flexible daily doses in the range of 50 to 200 mg or placebo (N = 108). Primary outcome measures consisted of the Clinician-Administered PTSD Scale (CAPS-2) total severity score, the patient-rated Impact of Event Scale (IES), and the Clinical Global Impression-Severity (CGI-S) and -Improvement (CGI-I) ratings.

Results  Mixed-effects analyses found significantly steeper improvement slopes for sertraline compared with placebo on the CAPS-2 (t = 2.96, P = .003), the IES (t = 2.26, P = .02), the CGI-I score (t = 3.62, P<.001), and the CGI-S score (t = 4.40, P<.001). An intent-to-treat end-point analysis found a 60% responder rate for sertraline and a 38% responder rate for placebo (²₁ = 8.48, P = .004). Sertraline treatment was well tolerated, with a 9% discontinuation rate because of adverse events, compared with 5% for placebo. Adverse events that were significantly more common in subjects given sertraline compared with placebo consisted of insomnia (35% vs 22%), diarrhea (28% vs 11%), nausea (23% vs 11%), fatigue (13% vs 5%), and decreased appetite (12% vs 1%).

Conclusion  The results of the current study suggest that sertraline is a safe, well-tolerated, and significantly effective treatment for PTSD.

From the Anxiety and Traumatic Stress Program, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC (Dr Davidson); the Emory Clinic and Department of Psychiatry and Behavioral Sciences, Atlanta, Ga (Dr Rothbaum); the Human Resource Institute, Brookline, Mass (Dr van der Kolk); and Pfizer Inc, New York, NY (Drs Sikes and Farfel).

Corresponding author and reprints: Jonathan R.T. Davidson, MD, Department of Psychiatry and Behavioral Sciences, Anxiety and Traumatic Stress Program, Duke University Medical Center, Box 3812, Durham, NC 27710.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Pharmacological treatment of post-traumatic stress disorder
Bisson
Adv. Psychiatr. Treat. 2007;13:119-126.
ABSTRACT | FULL TEXT  

Treatment of Posttraumatic Stress Disorder With Venlafaxine Extended Release: A 6-Month Randomized Controlled Trial.
Davidson et al.
Arch Gen Psychiatry 2006;63:1158-1165.
ABSTRACT | FULL TEXT  

Clinicians' Perspectives on Cognitive-Behavioral Treatment for PTSD Among Persons With Severe Mental Illness
Frueh et al.
Psychiatr. Serv. 2006;57:1027-1031.
ABSTRACT | FULL TEXT  

Current Concepts in Pharmacotherapy for Posttraumatic Stress Disorder
Schoenfeld et al.
Psychiatr. Serv. 2004;55:519-531.
ABSTRACT | FULL TEXT  

Prescribing Patterns for Patients With Posttraumatic Stress Disorder
Mellman et al.
Psychiatr. Serv. 2003;54:1618-1621.
ABSTRACT | FULL TEXT  

Baclofen Treatment for Chronic Posttraumatic Stress Disorder
Drake et al.
The Annals of Pharmacotherapy 2003;37:1177-1181.
ABSTRACT | FULL TEXT  

Posttraumatic Stress Disorder
Connor and Butterfield
Focus 2003;1:247-262.
ABSTRACT | FULL TEXT  

Efficacy of Sertraline in Preventing Relapse of Posttraumatic Stress Disorder: Results of a 28-Week Double-Blind, Placebo-Controlled Study
Davidson et al.
Focus 2003;1:273-281.
ABSTRACT | FULL TEXT  

Fluoxetine may prevent relapse in post traumatic stress disorder
Butterfield
Evid. Based Ment. Health 2003;6:51-51.
FULL TEXT  

Adjunctive Olanzapine for SSRI-Resistant Combat-Related PTSD: A Double-Blind, Placebo-Controlled Study
Stein et al.
Am. J. Psychiatry 2002;159:1777-1779.
ABSTRACT | FULL TEXT  

A 46-Year-Old Man With Anxiety and Nightmares After a Motor Vehicle Collision
Stein
JAMA 2002;288:1513-1521.
FULL TEXT  

Post-Traumatic Stress Disorder
Yehuda
NEJM 2002;346:108-114.
FULL TEXT  

Efficacy of Sertraline in Preventing Relapse of Posttraumatic Stress Disorder: Results of a 28-Week Double-Blind, Placebo-Controlled Study
Davidson et al.
Am. J. Psychiatry 2001;158:1974-1981.
ABSTRACT | FULL TEXT  

Other articles noted
Evid. Based Ment. Health 2001;4:104-104.
FULL TEXT  

Recognition and Treatment of Posttraumatic Stress Disorder
Davidson
JAMA 2001;286:584-588.
FULL TEXT