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

Completed · Phase 3 · Has a placebo group

Conditions studied: PTSD

In brief

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.

Key facts

Study ID

NCT00108576

Run by

VA Office of Research and Development

People needed

101

Starts

2003-10-01

Expected to finish

2005-09-01

Last updated by the study team

2015-10-21

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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