Drug Treatment for Alcoholics With Bipolar Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcoholism, Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00000439

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

72

Starts

2000-10-01

Expected to finish

2003-08-01

Last updated by the study team

2018-01-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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