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

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT00203463
First received: September 12, 2005
Last updated: July 28, 2009
Last verified: July 2009
  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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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 Janssen Scientific Affairs, LLC
Investigators
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 April 17, 2014