Drug Treatment for Alcoholics With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Efficacy of Valproate Maintenance in Bipolar Alcoholics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000439
• Other study ID #: NIAAASAL10523
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: January 16, 2018
• Start date: October 2000
• Est. completion date: August 2003

Study information

• Verified date: January 2018
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism
• Bipolar Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salloum IM, Cornelius JR, Daley DC, Kirisci L, Himmelhoch JM, Thase ME. Efficacy of valproate maintenance in patients with bipolar disorder and alcoholism: a double-blind placebo-controlled study. Arch Gen Psychiatry. 2005 Jan;62(1):37-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of heavy drinking days	Change from baseline	6 months
Secondary	Changes in depressive and manic symptoms	Changes in depressive and manic symptoms scores from baseline	6 months