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A randomized, double-blind, placebo-controlled trial to assess the efficacy of topiramate in the treatment of post-traumatic stress disorder
BMC Psychiatry, 06/02/09
Mello MF et al. - The development of treatments for PTSD is challenging due to the complexity of the symptoms and psychiatric comorbidities. The 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.
Methods- Seventy-two adult outpatients with DSM-IV-diagnosed PTSD will be recruited from the violence program of Federal University of Sao Paulo Hospital (UNIFESP).
- fter 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.
- Patients in the topiramate group that completed the study, had a significant improvement in the reexperiencing subscale of the CAPS suggesting efficacy for the patients that continued the medication.
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