Maintenance Phase Treatment With Divalproex for Post Traumatic Stress Disorder

Stopped early · Phase 4

Conditions studied: PTSD

In brief

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

Key facts

Study ID

NCT00203385

Run by

Tuscaloosa Research & Education Advancement Corporation

People needed

20

Starts

2003-05-01

Expected to finish

2005-03-01

Last updated by the study team

2017-04-26

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 breastfeed during the study

Where it is running

• Tuscaloosa Research & Education Advancement Corporation — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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