Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms

Summary

The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.

Timeline

Start

2004-09

Primary completion

2006-07

Completion

2006-07

Publications

• Background Brady KT, Myrick H, Henderson S, Coffey SF. The use of divalproex in alcohol relapse prevention: a pilot study. Drug Alcohol Depend. 2002 Aug 1;67(3):323-30. doi: 10.1016/s0376-8716(02)00105-9.
• Background Hertzman M. Divalproex sodium to treat concomitant substance abuse and mood disorders. J Subst Abuse Treat. 2000 Jun;18(4):371-2. doi: 10.1016/s0740-5472(99)00080-x.
• Background Reoux JP, Saxon AJ, Malte CA, Baer JS, Sloan KL. Divalproex sodium in alcohol withdrawal: a randomized double-blind placebo-controlled clinical trial. Alcohol Clin Exp Res. 2001 Sep;25(9):1324-9.

Drugs

Indications