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Sponsors and Collaborators: |
Creighton University Ortho-McNeil Pharmaceutical |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00208130 |
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.
Condition | Intervention | Phase |
---|---|---|
Post-Traumatic Stress Disorder |
Drug: Topiramate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 60 |
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.
Ages Eligible for Study: | 19 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must:
If (c) or (d), subjects must have a negative urine pregnancy test up to one week prior to Visit 2 (Day 1).
Exclusion Criteria:
Subjects who are currently enrolled in a cognitive-behavioral therapy program.
Note: Subjects may be receiving concurrent psychotherapy (other than cognitive-behavioral therapy), but subjects must not initiate new psychotherapy treatment during their participation in the trial.
United States, Nebraska | |
Creighton University Psychiatry and Research Center | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Frederick Petty, MD, PhD | Creighton University |
Study ID Numbers: | CAPSS-201 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00208130 |
Health Authority: | United States: Institutional Review Board |
PTSD trauma |
Anxiety Disorders Mental Disorders Wounds and Injuries Topiramate |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |