Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)
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Purpose
To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.
| Condition | Intervention | Phase |
|---|---|---|
|
PTSD |
Drug: topiramate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD) |
- Potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD as noted in the change of the 17-item total severity score of the Clinician-Administered PTSD scale (CAPS) from baseline to the last visit of Double-Blind Phase (8-weeks) [ Time Frame: (8-weeks) ] [ Designated as safety issue: No ]
- Changes from baseline to the last visit in Double-Blind Phase for HAM-A, MADRS, and TOP-8 Scale, Clinical Global Impression (CGI)scales, and Davidson Trauma Scale (DTS). Each scale will be analyzed as described above for the primary efficacy variable. [ Time Frame: (8-weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2001 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| Tuscaloosa Research & Education Advancement Corporation | |
| Tuscaloosa, Alabama, United States, 35404 | |
| Principal Investigator: | Lori L Davis, MD | Tuscaloosa VA Medical Center |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00203463 History of Changes |
| Other Study ID Numbers: | TREAC Topiramate in PTSD, TREAC Topiramate in PTSD |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
|
topiramate PTSD posttraumatic stress disorder topamax |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Topiramate Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 22, 2013