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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203463
• Other study ID #: TREAC Topiramate in PTSD
• Secondary ID: TREAC Topiramate
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: July 28, 2009
• Start date: July 2001
• Est. completion date: September 2004

Study information

• Verified date: July 2009
• Source: Tuscaloosa Research & Education Advancement Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• topiramate

Locations

Country	Name	City	State
United States	Tuscaloosa Research & Education Advancement Corporation	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Tuscaloosa Research & Education Advancement Corporation	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		(8-weeks)	No
Secondary	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.		(8-weeks)	No