Viewing Study NCT00208130



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Study NCT ID: NCT00208130
Status: COMPLETED
Last Update Posted: 2009-04-29
First Post: 2005-09-13

Brief Title: Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians
Sponsor: Creighton University
Organization: Creighton University

Study Overview

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
Status: COMPLETED
Status Verified Date: 2009-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None