Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults
Attention Deficit and Disruptive Behavior Disorders, Marijuana Abuse
About this trial
This is an interventional treatment trial for Attention Deficit and Disruptive Behavior Disorders focused on measuring ADHD, disruptive behavior disorder, marijuana abuse
Eligibility Criteria
Inclusion Criteria: 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per month Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior Chronic symptoms, defined of at least 1 year duration when not receiving treatment Impairment from the above symptoms in two or more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 Criteria: 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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Divalproex sodium (Depakote). This is a parallel groups design lasting a total of six weeks. Participants will be on a fixed-flexible dosing schedule. The dose of depakote will be raised to 750mgs or 1000mgs, depending on weight, in two weeks to achieve blood levels between 50-130 micrograms per milliliter. If a patient does not achieve this blood level on 750mgs or 1000 mgs, the dose may be raised during the second week.
This is a parallel groups design lasting a total of six weeks. Participants will be on matching placebo for 250 mgs divalproex sodium (Depakote).