Status:
COMPLETED
Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
Abbott
Conditions:
Alcoholism
Alcohol Related Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence...
Detailed Description
Alcohol dependence afflicts 14 million individuals in the U.S. The alcohol related costs to society are enormous and alcohol dependence is a significant public health problem. Although pharmacotherapy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00202514
Start Date
September 1 2004
End Date
July 1 2006
Last Update
October 8 2009
Active Locations (1)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108