NCT00000439

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2000

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

November 2, 1999

Last Update Submit

January 16, 2018

Conditions

AlcoholismBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in proportion of heavy drinking days

    Change from baseline

    6 months

Secondary Outcomes (1)

  • Changes in depressive and manic symptoms

    6 months

Study Arms (2)

sodium valproate

ACTIVE COMPARATOR

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

Drug: sodium valproate

placebo

PLACEBO COMPARATOR

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

Drug: sodium valproate

Interventions

sodium valproateDRUG

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
placebosodium valproate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

    PMID: 15630071RESULT

MeSH Terms

Conditions

AlcoholismBipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Ihsan M Salloum, MD, MPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

October 1, 2000

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)