Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians
The primary objective of this study is to investigate the safety and efficacy of topiramate in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-IV.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians|
- The primary efficacy variable for this study will be the change of the 17-item total severity score of the CAPS from baseline to the last visit of Double-Blind Phase.
- The secondary efficacy variables consist of changes from baseline to the last visit in Double-Blind Phase of HARS, Ham-D, TOP-8 and CGI at the last visit of Double-Blind Phase.
|Study Start Date:||October 2001|
|Estimated Study Completion Date:||March 2004|
Psychopharmacologic treatment of PTSD has been informed by only limited empirical data. Prior to the recently completed multi-site trials for sertraline conducted by Pearlstein and colleagues which found efficacy for women but not men suffering from chronic PTSD, there were only a handful of published randomized controlled trials. An overview of this literature suggests that tricyclic antidepressants, monoamine inhibitors and selective seratonin reuptake inhibitors (SSRIs) show promise, usually with better responses in civilians with PTSD than in male veterans with combat-related PTSD. Although results from open-label studies of alpha-2 agonists, beta blockers, anticonvulsants, and mood stabilizing agents appear to be promising, at present no one agent has emerged as useful for a broad range of PTSD sufferers.
This is a single-center, outpatient, randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety and efficacy of topiramate in treating PTSD in civilian trauma. This study will be conducted in up to 60 subjects with a diagnosis of PTSD as defined by DSM-IV criteria. Thirty subjects will be assigned to topiramate and 30 will be assigned to placebo.
|United States, Nebraska|
|Creighton University Psychiatry and Research Center|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Frederick Petty, MD, PhD||Creighton University|