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

Phase 4CompletedNCT00203463

Tuscaloosa Research & Education Advancement Corporation40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

PTSD

Interventions

topiramateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa, Alabama, United States

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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