Drug Treatment for Alcoholics With Bipolar Disorder

Phase 2

Completed

• Conditions: Alcoholism; Bipolar Disorder
• Interventions: Drug: sodium valproate

• Registration Number: NCT00000439
• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief 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.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Study Start: 2000-10
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Meets the criteria for alcohol dependence with comorbid bipolar disorder.
• Agreement to participate in outpatient treatment.
• Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo.
• Stable living situation.
• Ability to provide informed consent.

Exclusion Criteria

• Psychiatric conditions including schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, unipolar major depression, mental retardation, or signs of impaired cognitive functioning.
• Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination.
• Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery.
• Persistent elevation of liver function enzymes indicating active liver disease.
• Pregnancy or not using an acceptable contraceptive method.
• Inability to read or understand study forms; agree to informed consent.
• Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder.
• The presence of either/or cocaine dependence, opioid dependence, and intravenous drug use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	sodium valproate	Placebo comparator was added on treatment as usual and dose monitored by blood level measurements
sodium valproate	sodium valproate	sodium valproate was added on treatment as usual and dose monitored by blood level measurements

Primary Outcome Measures

Name	Time	Method
Change in proportion of heavy drinking days	6 months	Change from baseline

Secondary Outcome Measures

Name	Time	Method
Changes in depressive and manic symptoms	6 months	Changes in depressive and manic symptoms scores from baseline

Trial Locations

Locations (1)

Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States