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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 28, 2009

Start Date ^ICMJE

July 2001

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00203463 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

PTSD

Intervention ^ICMJE

Drug: topiramate

Study Arms / Comparison Groups

Publications *

Berlant JL. Topiramate in posttraumatic stress disorder: preliminary clinical observations. J Clin Psychiatry. 2001;62 Suppl 17:60-3.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2004

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00203463

Responsible Party

Study ID Numbers ^ICMJE

TREAC Topiramate in PTSD, TREAC Topiramate in PTSD

Study Sponsor ^ICMJE

Tuscaloosa Research & Education Advancement Corporation

Collaborators ^ICMJE

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators ^ICMJE

Principal Investigator:

Lori L Davis, MD

Tuscaloosa VA Medical Center

Information Provided By

Tuscaloosa Research & Education Advancement Corporation

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP