Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence

March 30, 2015 updated by: The University of Texas Medical Branch, Galveston

An Open Label Pilot Study Evaluating Safety and Efficacy of Divalproex Sodium (Depakote ER) in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence.

The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Over half of all patients with bipolar disorder have comorbid substance abuse. The most common substance of abuse is alcohol, which is most commonly associated with the depressed phase of the illness. Although there are available treatments for bipolar depression, no studies have been done to evaluate efficacy in bipolar patients with comorbid substance abuse disorders. Given the independent open-label evidence for efficacy and safety of divalproex sodium in alcohol abuse and bipolar depression, divalproex sodium is the most likely candidate for potential success in bipolar depressed patients with comorbid alcohol abuse or dependence. The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.

Study Type

Interventional

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
    • Texas
      • Galveston, Texas, United States, 77555-0188
        • University of Texas Medical Branch

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:

  • MADRS >= 20 at screen and 18 at baseline
  • YMRS =< 11 at screen and baseline
  • DMS-IV criteria for past manic or hypomanic episode based on the SCID
  • DSM-VI criteria for alcohol dependence or abuse based on the SCID.
  • Alcohol dependence/abuse confirmed by corroboration from family member
  • Negative urine pregnancy test

Exclusion Criteria:

  • Inability to give informed consent
  • Inability to give reliable assessment of alcohol consumption
  • Evidence of alcohol consumption one week prior to baseline
  • Liver function tests greater than 3X upper limit of normal at screen
  • History of active hepatitis or hepatic encephalopathy
  • History of pancreatitis
  • History of adverse reaction to divalproex sodium
  • History of seizure other than directly associated w/prior alcohol withdrawl
  • History of major head trauma with LOC > 10 min. or skull fracture
  • Hisotry of hypertension or neurologic illness
  • If female, not practicing an effective form of birth control

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary Efficacy Measures for this study are: Percent change in MADRS from baseline score to study endpoint; Percent of days heavy drinking from 120 days prescreen to study end point; and Percent of subjects successfully completing outpatient detox.

Secondary Outcome Measures

Outcome Measure
Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16.

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Michael Stone, M.D., University of Texas Medical Branch at Galveston

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

June 1, 2003

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-048
  • FRS 467640

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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