Completed

Efficacy of Valproate Maintenance in Bipolar Alcoholics

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What is being tested

sodium valproate

+ sodium valproate

Drug
Who is being recruted

Bipolar and Related Disorders+5

+ Mental Disorders

+ Mood Disorders

From 18 to 65 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2000
See protocol details

Summary

Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: January 18, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2000

Actual date on which the first participant was enrolled.

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.

NCT00000439
Principal SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last updated: January 18, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bipolar and Related DisordersMental DisordersMood DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced DisordersAlcoholismBipolar Disorder

Criteria

5 inclusion criteria required to participate
Ability to provide informed consent
Ability to tolerate lithium carbonate and be randomized to receive sodium valproate or placebo
Agreement to participate in outpatient treatment
Meets the criteria for alcohol dependence with comorbid bipolar disorder
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8 exclusion criteria prevent from participating
Impending incarceration or a mandate to attend treatment by the legal system for an alcohol use disorder
Inability to read or understand study forms; agree to informed consent
Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, other impairing or unstable medical condition or impending surgery
Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or focally abnormal electroencephalographic examination
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Pittsburgh, United StatesOpen Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center in Google Maps
CompletedOne Study Center