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

NCT00204503 | Withdrawn Phase 2

• 2 other identifiers: 03-048FRS 467640
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar I or II Depression and Alcohol Abuse or Dependence

Keywords

Bipolar I or II; Depression; Alcohol Abuse or Dependence; Mental Health Issues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Depakote ER DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0188, United States

Location

MeSH Terms

Conditions

Alcoholism; Depression

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Michael Stone, M.D.

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2003
• Study Completion: May 1, 2005
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

US (1)