Status:
TERMINATED
Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder
Lead Sponsor:
Tuscaloosa Research & Education Advancement Corporation
Conditions:
PTSD
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.
Detailed Description
Patients who have participated in the 8-week randomized, double-blind, placebo-controlled treatment trial of divalproex for PTSD and have signed informed consent will be enrolled in a 24-week open-lab...
Eligibility Criteria
Inclusion
- Diagnosis of PTSD, confirmed by MINI and CAPS.
- Participation in the placebo-controlled acute phase study with divalproex for PTSD
- Age 19 or older
- No substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine)
- Clinically normal physical and laboratory examination (lab profile listed below). LFTs 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, DepoProvera, or diaphragm with spermicide)
- Signed informed consent
- Male or female, any race or ethic 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 breastfeed during the study
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00203385
Start Date
May 1 2003
End Date
March 1 2005
Last Update
April 26 2017
Active Locations (1)
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1
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404