Divalproex Sodium in the Treatment of PTSD (Post-Traumatic Stress Disorder)

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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 in PTSD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Anticonvulsants; Valproic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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