The Comparison of Topiramate and Placebo in the Treatment of Posttraumatic Stress Disorder: A Randomized, Double- Blind Study

Abstract

Background: Posttraumatic stress disorder (PTSD) is a chronic illness and a difficult – to – treat condition. The Hypothesis that exposure to Traumatic events may sensitize or kindle limbic nuclei has led to efforts to treat PTSD with anticonvulsants. Based on the kindling hypothesis of PTSD, this clinical trial was designed to assess the clinical response to topiramate (a new anticonvulsant) as a potential Treatment for PTSD. Methods: Sixty seven combat veterans with PTSD (range 30-50 years old; SD: 39.5 ± 4.19) randomly assigned in a double – blind design. They were Treated for 12 weeks with topiramat (N=34, 50-500 mg/day) as add – on therapy or placebo (N=33). Patients were monthly assessed for three consecutive months using Clinician – Administered PTSD Scale (CAPS). Results:Two patients were withdrawn from the study because of topiramate side effects.In reminders, the mean Score of topiramate group, in the first visit was 50.70 ± 7.7 and the mean score of placebo group was 48.9 ± 9.13. After finishing the treatment period, the mean score of the topiramate group was 32.75 ± 8.2 and of the placebo group was 46.62 ± 8.8. The analysis of these scores showed a significant difference between the two groups (P=0.00). Frequency and intensity of re-experience criteria (intrusive memory, night mare, and flash back), sleep problem, irritability, anger, frequency of difficulty to recall, and intensity of startle reaction in topiramate group was significantly less than placebo group (P < 0.05). Conclusion: The results of this study suggest that topiramate is a safe, well – tolerated, and significantly effective Treatment for PTSD.
Keywords: PTSD, Topiramate, Anticonvulsant.