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OpenTrials
Completed

NCT Number: NCT00000439

Drug Treatment for Alcoholics With 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Valproate

Drug

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.

Other names: Depakote, Divalproex sodium, Depacon

Primary outcomes

  1. Change in proportion of heavy drinking days

    Time frame: 6 months

    Change from baseline

Secondary outcomes

  1. Changes in depressive and manic symptoms

    Time frame: 6 months

    Changes in depressive and manic symptoms scores from baseline

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Collaborators

  • University of Pittsburgh

Registry information

Official study title

Efficacy of Valproate Maintenance in Bipolar Alcoholics

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Nov 3, 1999
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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