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CompletedNCT00000439Updated Jan 18, 2018

Drug Treatment for Alcoholics With Bipolar Disorder

A Phase 2 interventional study of sodium valproate in Alcoholism and Bipolar Disorder, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Alcoholism
  • Bipolar Disorder
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In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 72 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 98 studies on the registry; 17 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    sodium valproate

    sodium valproate was added on treatment as usual and dose monitored by blood level measurements

    Drug: sodium valproate

  • Placebo comparator
    placebo

    Placebo comparator was added on treatment as usual and dose monitored by blood level measurements

    Drug: sodium valproate

Interventions

  • Drugsodium 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.

    Also known as: Depakote, Divalproex sodium, Depacon

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What researchers measure

Primary outcomes

  1. Change in proportion of heavy drinking days

    Change from baseline

    Time frame: 6 months

Secondary outcomes

  1. Changes in depressive and manic symptoms

    Changes in depressive and manic symptoms scores from baseline

    Time frame: 6 months

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Study locations

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

Publications

  • Salloum IM, Cornelius JR, Daley DC, Kirisci L, Himmelhoch JM, Thase ME. Efficacy of valproate maintenance in patients with bipolar disorder and alcoholism: a double-blind placebo-controlled study. Arch Gen Psychiatry. 2005 Jan;62(1):37-45. doi: 10.1001/archpsyc.62.1.37. PubMed 15630071 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000439
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators
University of Pittsburgh
Responsible party
Sponsor
First posted
Nov 3, 1999
Start date
Oct 2000
Primary completion
Aug 2003
Completion
Aug 2003
Last update
Jan 18, 2018

Study contacts

Ihsan M Salloum, MD, MPH
principal investigator · University of Miami

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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