Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)
This study has been completed.
Sponsors and Collaborators: Tuscaloosa Research & Education Advancement Corporation
Ortho-McNeil Pharmaceutical
Information provided by: Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00203463
  Purpose

To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.


Condition Intervention Phase
PTSD
Drug: topiramate
Phase IV

MedlinePlus related topics: Post-Traumatic Stress Disorder
Drug Information available for: Topiramate
U.S. FDA Resources
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)

Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD

Estimated Enrollment: 40
Study Start Date: July 2001
Estimated Study Completion Date: September 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203463

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

Publications:
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

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

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Topiramate
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Anti-Obesity Agents
Therapeutic Uses
Physiological Effects of Drugs
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009