Topiramate in PTSD - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

PTSD

Intervention / Treatment

Drug: topiramate

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 Type

Interventional

Enrollment

40

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Tuscaloosa, Alabama, United States, 35404
    - Tuscaloosa Research & Education Advancement Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	(8-weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	(8-weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuscaloosa Research & Education Advancement Corporation

Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria