Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms

NCT00202514 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-10-08

No results posted yet for this study

Summary

The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.

Conditions

  • Alcoholism
  • Alcohol Related Disorders
  • Mood Disorders

Interventions

DRUG

divalproex sodium extended release

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY
  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Joseph P Reoux, MD · Veterans Affairs and University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202514 on ClinicalTrials.gov