Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)
1 other identifier
interventional
40
1 country
1
Brief Summary
To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2001
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedJuly 29, 2009
July 1, 2009
3.2 years
September 12, 2005
July 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, 35404, United States
Related Publications (1)
Berlant JL. Topiramate in posttraumatic stress disorder: preliminary clinical observations. J Clin Psychiatry. 2001;62 Suppl 17:60-3.
PMID: 11495099BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori L Davis, MD
Tuscaloosa Veterans Affairs Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
July 1, 2001
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
July 29, 2009
Record last verified: 2009-07