Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit and Disruptive Behavior Disorders, Marijuana Abuse

In brief

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.

Key facts

Study ID

NCT00218114

Run by

New York State Psychiatric Institute

People needed

25

Starts

2000-02-01

Expected to finish

2005-02-18

Last updated by the study team

2017-08-10

Who can join

Age: 12 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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• Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior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

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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