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Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)

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ClinicalTrials.gov Identifier: NCT00203463
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 29, 2009
Information provided by:

Study Description
Brief Summary:
To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.

Condition or disease Intervention/treatment Phase
PTSD Drug: topiramate Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)
Study Start Date : July 2001
Primary Completion Date : September 2004
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203463

United States, Alabama
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: Lori L Davis, MD Tuscaloosa VA Medical Center
More Information

ClinicalTrials.gov Identifier: NCT00203463     History of Changes
Other Study ID Numbers: TREAC Topiramate in PTSD
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 29, 2009
Last Verified: July 2009

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
posttraumatic stress disorder

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents