NCT00000439

Drug Treatment for Alcoholics With Bipolar Disorder

Efficacy of Valproate Maintenance in Bipolar Alcoholics

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.

Detailed description

The aim of this study is to test the mood stabilizer, anticonvulsant, sodium valproate in individuals with alcohol dependence and bipolar disorder, in a double-blind, placebo-controlled, and randomized trial of 6 months duration. All subjects are treated with treatment as usual, which include lithium carbonate and individual dual recovery counseling and are randomized to either sodium valproate or placebo.

Conditions

• Alcoholism
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	sodium valproate	subjects were randomized to sodium valproate vs placebo. Serum sodium valproate was monitored. This intervention was added on treatment as usual which was defined as being on lithium carbonate and also attending individual dual recovery counseling.

Timeline

• Start date: 2000-10-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 1999-11-03
• Last updated: 2018-01-18

Locations

1 site across 1 country: United States