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Sponsors and Collaborators: |
Tuscaloosa Research & Education Advancement Corporation Ortho-McNeil Pharmaceutical |
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Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
ClinicalTrials.gov Identifier: | NCT00203463 |
To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.
Condition | Intervention | Phase |
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PTSD |
Drug: topiramate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD) |
Estimated Enrollment: | 40 |
Study Start Date: | July 2001 |
Estimated Study Completion Date: | September 2004 |
This is a twelve-week randomized, double blind, placebo controlled trial of topiramate for 40 patients with PTSD. Diagnoses are made by Structured Clinical Interview for DSM-IV (SCID). Symptom severity is measured with the Clinician Administered PTSD Scale (CAPS), Davidson Trauma Scale (DTS), Treatment Outcome PTSD (TOP-8), Clinical Global Impressions (CGI), and the Hamilton Rating Scales for Depression and Anxiety (HAM-D and HAM-A). The Clinician Administered PTSD Scale (CAPS) is the primary outcome measure. Subjects will read and sign informed consent prior to beginning any study procedures. Subjects who meet inclusion/exclusion criteria will be randomized 1:1 (Topiramate : placebo) to study medication. Study medication is initiated at one tablet daily (25mg topiramate or placebo) and medication will be increased by 25-100mg (1 tablet) increments every 7 days, as tolerated, until a maximum benefit is achieved, not to exceed 400mg/day. Patients will be seen every week up until Visit 4, and then will be seen every two weeks for the remainder of the study for assessment of efficacy and side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Tuscaloosa Research & Education Advancement Corporation | |
Tuscaloosa, Alabama, United States, 35404 |
Principal Investigator: | Lori L Davis, MD | Tuscaloosa VA Medical Center |
Study ID Numbers: | TREAC Topiramate in PTSD, TREAC Topiramate in PTSD |
Study First Received: | September 12, 2005 |
Last Updated: | December 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00203463 |
Health Authority: | United States: Food and Drug Administration |
topiramate PTSD posttraumatic stress disorder topamax |
Anxiety Disorders Mental Disorders Topiramate |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |