Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms
Alcoholism, Alcohol Related Disorders, Mood Disorders
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring alcoholism, alcohol related disorders, mood disorders, anticonvulsants, divalproex sodium
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant or nursing female age 18 to 65 years old. Females of childbearing potential must agree to practice an acceptable form of birth control during the time enrolled in the study. Diagnosis of DSM-IV alcohol dependence (DSM-IV checklist). Sub-syndromal mood and/or anxiety symptoms (threshold score of 1 standard deviation above the mean for non-psychiatric population on the anxiety, depression, hostility, or global severity subscales of the SCL-90). Subjects must be able to understand and sign an informed consent approved by the center's Institutional Review Board. Exclusion Criteria: Opioid dependence as the primary substance diagnosis. Clearly established non-substance related psychiatric disorder determined by administration of the Structured Clinical Interview for DSM-IV (SCID-IV) requiring immediate medication treatment. Concurrent need for ongoing treatment with a benzodiazepine, anticonvulsants, or medications with significant drug-drug interaction with DVP. Severe liver disease (ascites, jaundice, encephalopathy) suggested by physical exam. AST or ALT > 200 U/L; total bilirubin > 2.5 mg/dl. PT > 1.5X normal. Platelet count < 100,000/cubic mm, or WBC < 3,000/cubic mm. Pancreatitis (clinical signs and symptoms, not solely based on blood tests). Known allergy to DVP or valproic acid. Pregnancy.
Sites / Locations
- VA Puget Sound Health Care System