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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborator: Abbott
• Treatments: Ethanol; Valproic Acid

Criteria

Inclusion Criteria:

1. Male or non-pregnant or nursing female age 18 to 65 years old.

2. Females of childbearing potential must agree to practice an acceptable form of birth control during the time enrolled in the study.

3. Diagnosis of DSM-IV alcohol dependence (DSM-IV checklist).

4. Sub-syndromal mood and/or anxiety symptoms (threshold score of 1 standard deviation above the mean for non-psychiatric population on the anxiety, depression, hostility, or global severity subscales of the SCL-90).

5. Subjects must be able to understand and sign an informed consent approved by the center's Institutional Review Board.

Exclusion Criteria:

1. Opioid dependence as the primary substance diagnosis.

2. Clearly established non-substance related psychiatric disorder determined by administration of the Structured Clinical Interview for DSM-IV (SCID-IV) requiring immediate medication treatment.

3. Concurrent need for ongoing treatment with a benzodiazepine, anticonvulsants, or medications with significant drug-drug interaction with DVP.

4. Severe liver disease (ascites, jaundice, encephalopathy) suggested by physical exam.

5. AST or ALT > 200 U/L; total bilirubin > 2.5 mg/dl.

6. PT > 1.5X normal.

7. Platelet count < 100,000/cubic mm, or WBC < 3,000/cubic mm.

8. Pancreatitis (clinical signs and symptoms, not solely based on blood tests).

9. Known allergy to DVP or valproic acid.

10. Pregnancy.