Status:
COMPLETED
Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Attention Deficit and Disruptive Behavior Disorders
Marijuana Abuse
Eligibility:
All Genders
12-55 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness of divalproex sodium (Depakote) versus placebo in treating disruptive behavior disorder and explosive tempers in adolescents and adults.
Detailed Description
Disruptive behavior disorders among children and adolescents are readily diagnosed; however, few individuals with such disorders receive drug treatment. Depakote is a mood stabilizing medication that ...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for a disruptive behavior disorder (e.g., oppositional/defiant disorder, conduct disorder)
- Explosive temper, defined as four or more outbursts of rage, property destruction, or fighting per month
- Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior
- Chronic symptoms, defined of at least 1 year duration when not receiving treatment
- Impairment from the above symptoms in two or more areas, including school, the law, family, substance use, peers, or work (as manifested by a GAF score of 55 or less)
- Symptoms not limited to a particular place or to particular intimate relationships
- General good health
- Custodial parent or guardian gives informed consent
Exclusion
- History of non drug-induced psychosis
- Seizure or other neurologic disturbance
- Pregnant
- Moderate to severe mental retardation
- Sexually active females who refuse to use an adequate method of contraception for the duration of the study
- Significant medical problems
- Current suicidal or homicidal ideation
- Uses barbiturates
- Refusal to permit weekly contact with school officials
- Bipolar I or II disorder
- Major depressive disorder
- First degree relative with bipolar I or II disorder
- Attention deficit/hyperactivity disorder
- Post traumatic stress disorder
- Clinical evidence of hyperandrogenism in a female
- Liver disease
- Thrombocytopenia
- Pancreatic disease
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00218114
Start Date
February 1 2000
End Date
February 18 2005
Last Update
August 10 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032