Status:
COMPLETED
Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)
Lead Sponsor:
Tuscaloosa Research & Education Advancement Corporation
Collaborating Sponsors:
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
PTSD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 severit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00203463
Start Date
July 1 2001
End Date
September 1 2004
Last Update
July 29 2009
Active Locations (1)
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1
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404