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Open Access Study protocol

A randomized, double-blind, placebo-controlled trial to assess the efficacy of topiramate in the treatment of post-traumatic stress disorder

Marcelo Feijó Mello, Mary Sau Ling Yeh, Jair Barbosa Neto, Luciana Lorens Braga, Jose Paulo Fiks, Daniela Deise Mendes, Tais S Moriyama, Nina Leão Marques Valente, Mariana Caddrobi Pupo Costa, Patricia Mattos, Rodrigo Affonseca Bressan, Sergio Baxter Andreoli and Jair Jesus Mari*

Author Affiliations

Department of Psychiatry, Universidade federal de São Paulo, São Paulo, Brazil

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BMC Psychiatry 2009, 9:28  doi:10.1186/1471-244X-9-28

Published: 29 May 2009



Topiramate might be effective in the treatment of posttraumatic stress disorder (PTSD) because of its antikindling effect and its action in both inhibitory and excitatory neurotransmitters. Open-label studies and few controlled trials have suggested that this anticonvulsant may have therapeutic potential in PTSD. This 12-week randomized, double-blind, placebo-controlled clinical trial will compare the efficacy of topiramate with placebo and study the tolerability of topiramate in the treatment of PTSD.

Methods and design

Seventy-two adult outpatients with DSM-IV-diagnosed PTSD will be recruited from the violence program of Federal University of São Paulo Hospital (UNIFESP). After informed consent, screening, and a one week period of wash out, subjects will be randomized to either placebo or topiramate for 12 weeks. The primary efficacy endpoint will be the change in the Clinician-administered PTSD scale (CAPS) total score from baseline to the final visit at 12 weeks.


The development of treatments for PTSD is challenging due to the complexity of the symptoms and psychiatric comorbidities. The selective serotonin reuptake inhibitors (SSRIs) are the mainstream treatment for PTSD, but many patients do not have a satisfactory response to antidepressants. Although there are limited clinical studies available to assess the efficacy of topiramate for PTSD, the findings of prior trials suggest this anticonvulsant may be promising in the management of these patients.

Trial Registration

NCT 00725920