Drug Treatment for Alcoholics With Bipolar Disorder

January 16, 2018 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Efficacy of Valproate Maintenance in Bipolar Alcoholics

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sodium valproate
sodium valproate was added on treatment as usual and dose monitored by blood level measurements
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.
Other Names:
  • Depakote, Divalproex sodium, Depacon
Placebo Comparator: placebo
Placebo comparator was added on treatment as usual and dose monitored by blood level measurements
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.
Other Names:
  • Depakote, Divalproex sodium, Depacon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of heavy drinking days
Time Frame: 6 months
Change from baseline
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in depressive and manic symptoms
Time Frame: 6 months
Changes in depressive and manic symptoms scores from baseline
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (Estimate)

November 3, 1999

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAASAL10523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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