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

• Status: Completed
• Trial end date: 2005-02-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Valproic Acid

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• Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior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