Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence
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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.
Condition or disease
Bipolar I or II Depression and Alcohol Abuse or Dependence
Drug: Depakote ER
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.
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
Secondary Efficacy Measures for this study are: Percent change in IDS-SR and YMRS from baseline to end of week 16.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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