Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)
Information source: Tuscaloosa Research & Education Advancement Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: PTSD
Intervention: topiramate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Tuscaloosa Research & Education Advancement Corporation Official(s) and/or principal investigator(s):
Lori L Davis, MD, Principal Investigator, Affiliation: Tuscaloosa VA Medical Center
Summary
To study the potential therapeutic effects of topiramate (Topamax) in the treatment of
PTSD.
Clinical Details
Official title: Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)
Study design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of PTSD DSM-IV criteria
- No substance abuse/dependence for the previous 2 months (except for nicotine and
caffeine)
- Free of psychotropic medication, for 2 weeks (except 6 weeks for fluoxetine)
- Normal physical and laboratory examination (lab profile listed below)
- Negative urine screen for drugs of abuse
- Women of childbearing potential must be using nonpharmacologic medically approved
methods of birth control
- Signed informed consent
- Male or female, any race or ethic origin
Exclusion Criteria:
- Lifetime history of bipolar, psychotic, or cognitive disorders
- Suicidal, homicidal, or psychotic
- Diagnosis of bulimia or anorexia nervosa
- History of sensitivity to topiramate
- General medical conditions or ongoing treatment that contraindicate the use of
topiramate, such as seizure disorder or use of MAO inhibitors.
- Women planning to become pregnant or breastfeed during the study
Locations and Contacts
Tuscaloosa Research & Education Advancement Corporation, Tuscaloosa, Alabama 35404, United States
Additional Information
Related publications: Berlant JL. Topiramate in posttraumatic stress disorder: preliminary clinical observations. J Clin Psychiatry. 2001;62 Suppl 17:60-3.
Starting date: July 2001
Ending date: September 2004
Last updated: December 23, 2005
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