Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Pittsburgh, Pennsylvania 15213


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00000439


Primary Contact:

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


Backup Contact:

N/A


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: October 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.