Status:
COMPLETED
Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)
Lead Sponsor:
VA Office of Research and Development
Conditions:
PTSD
Eligibility:
All Genders
19-65 years
Phase:
PHASE3
Brief Summary
The purposes of this study are: * To study the efficacy of divalproex in the treatment of PTSD; * To study the plasma GABA (gamma aminobutyric acid) levels before and after treatment with divalproex ...
Detailed Description
Objective: To study the efficacy of divalproex in the treatment of PTSD. Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment trial of divalproex. Methodology: Af...
Eligibility Criteria
Inclusion
- Diagnosis of PTSD, confirmed by MINI (Mini-International Neuropsychiatric Interview) and CAPS
- Age 19 or older
- No substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine)
- Free of psychotropic medication for 2 weeks (except 6 weeks for fluoxetine)
- Clinically normal physical and laboratory examination (lab profile listed below). LFTs (liver function tests) up to 2.5 times the normal limit will be allowed.
- Women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, Depo-Provera, or diaphragm with spermicides)
- Signed informed consent
- Male or female of any race or ethnic origin
Exclusion
- Lifetime history of bipolar I, psychotic, or cognitive disorders
- Actively suicidal, homicidal, or psychotic
- History of sensitivity to divalproex
- Unstable general medical conditions
- Score 6 on Question #10 of MADRS
- Women who are pregnant, planning to become pregnant or to breastfeed during the study
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00108576
Start Date
October 1 2003
End Date
September 1 2005
Last Update
October 21 2015
Active Locations (1)
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1
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404