Pittsburgh, Pennsylvania 15213

  • Bipolar Disorder


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

Study summary:

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.


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.



Primary Contact:

Principal Investigator
Ihsan M Salloum, MD, MPH
University of Miami

Backup Contact:


Location Contact:

Pittsburgh, Pennsylvania 15213
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 13, 2021

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