Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence
Information source: The University of Texas, Galveston
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar I or II Depression and Alcohol Abuse or Dependence
Intervention: Depakote ER (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: The University of Texas, Galveston
Official(s) and/or principal investigator(s):
Michael Stone, M.D., Principal Investigator, Affiliation: University of Texas Medical Branch at Galveston
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
Official title: 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.
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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: Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
- 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
Locations and Contacts
University of Texas Medical Branch, Galveston, Texas 77555-0188, United States
Starting date: June 2003
Ending date: May 2005
Last updated: November 15, 2006