A Double-Blind Randomized Controlled Trial To Study the Efficacy of Topiramate in a Civilian Sample of PTSD

A Double-Blind Randomized Controlled Trial To Study the Efficacy of Topiramate in a Civilian Sample of PTSD

Author Yeh, Mary S. L. Autor UNIFESP Google Scholar
Mari, Jair Jesus Autor UNIFESP Google Scholar
Pupo Costa, Mariana Caddrobi Autor UNIFESP Google Scholar
Andreoli, Sergio Baxter Autor UNIFESP Google Scholar
Bressan, Rodrigo Affonseca Autor UNIFESP Google Scholar
Mello, Marcelo Feijo Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Univ London
Abstract Objective: To evaluate the efficacy and tolerability of topiramate in patients with post-traumatic stress disorder (PTSD). Method: We conducted a 12-week double-blind, randomized, placebo-controlled study comparing topiramate to placebo. Men and women aged 18-62 years with diagnosis of PTSD according to DSM-IV were recruited from the outpatient clinic of the violence program of Federal University of São Paulo Hospital (Prove-UNIFESP), São Paulo City, between April 2006 and December 2009. Subjects were assessed for the Clinician-Administered Posttraumatic Stress Scale (CAPS), Clinical Global Impression, and Beck Depression Inventory (BDI). After 1-week period of washout, 35 patients were randomized to either group. the primary outcome measure was the CAPS total score changes from baseline to the endpoint. Results: 82.35% of patients in the topiramate group exhibited improvements in PTSD symptoms. the efficacy analysis demonstrated that patients in the topiramate group exhibited significant improvements in reexperiencing symptoms: flashbacks, intrusive memories, and nightmares of the trauma (CAPS-B; P = 0.04) and in avoidance/numbing symptoms associated with the trauma, social isolation, and emotional numbing (CAPS-C; P = 0.0001). Furthermore, the experimental group demonstrated a significant difference in decrease in CAPS total score (topiramate -57.78; placebo -32.41; P = 0.0076). Mean topiramate dose was 102.94 mg/d. Topiramate was generally well tolerated. Conclusion: Topiramate was effective in improving reexperiencing and avoidance/numbing symptom clusters in patients with PTSD. This study supports the use of anti-convulsants for the improvement of symptoms of PTSD.
Keywords Clinician-administered PTSD scale
Posttraumatic stress disorder
Randomized controlled clinical trial
Topiramate
Language English
Sponsor Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Grant number FAPESP: 2004/15039-0
CAPES: 27909024886
Date 2011-01-01
Published in Cns Neuroscience & Therapeutics. Hoboken: Wiley-Blackwell, v. 17, n. 5, p. 305-310, 2011.
ISSN 1755-5930 (Sherpa/Romeo, impact factor)
Publisher Wiley-Blackwell
Extent 305-310
Origin http://dx.doi.org/10.1111/j.1755-5949.2010.00188.x
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000295178700005
URI http://repositorio.unifesp.br/handle/11600/33201

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