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Galveston, Texas 77555


Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT00204503


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Galveston, Texas 77555
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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