NCT00208130

Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Creighton University · Academic / Other
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Topiramate

Timeline

• Start date: 2001-10-01
• Completion: 2004-03-01
• First posted: 2005-09-21
• Last updated: 2009-04-29

Locations

1 site across 1 country: United States