Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

1. Diagnosis of PTSD, confirmed by MINI and CAPS.

2. Participation in the placebo-controlled acute phase study with divalproex for PTSD

3. Age 19 or older

4. No substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine)

5. Clinically normal physical and laboratory examination (lab profile listed below). LFTs up to 2.5 times the normal limit will be allowed.

6. 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)

7. Signed informed consent

8. Male or female, any race or ethic origin

Exclusion Criteria:

1. Lifetime history of bipolar I, psychotic, or cognitive disorders

2. Actively suicidal, homicidal, or psychotic

3. History of sensitivity to divalproex

4. Unstable general medical conditions

5. Score ≥ 6 on Question #10 of MADRS

6. Women who are pregnant, planning to become pregnant or breastfeed during the study