Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) versus placebo in treating children with temper outbursts and severe mood disorders.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Meets criteria for Explosive Mood Disorder (EMD)

• Explosive temper as evidenced by four or more outbursts of rage, property destruction, or fighting per month

• Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant

• History of an EMD for one year without treatment

• EMD symptoms resulting in impairment in two or more of the following areas: school, the law, family, substance use, peers, or work

• EMD symptoms do not occur only during substance toxicity or withdrawal

• EMD symptoms are not confined to a single setting or context

• Parent and child willing to consent to study

• Inadequate response to an adequate trial (8 weeks) of psychotherapy and/or family therapy

Exclusion Criteria:

• Meets criteria for pervasive developmental disorder or childhood schizophrenia

• Seizure or other neurologic disturbance

• Pregnant

• Moderate to severe mental retardation

• Physical exam or laboratory results with significant abnormalities

• Positive Hepatitis screen test

• Liver dysfunction

• Active suicidal or homicidal ideation

• History of suicide attempts

• History of barbiturate use

• Unequivocal manic or hypomanic episode

• Meets criteria for attention deficit hyperactivity disorder (ADHD) and has not failed a trial of psychostimulants for ADHD

• Meets criteria for major depression in prepuberty

• If female, unwilling to use an effective method of contraception for the duration of the study

• Mitochondrial disease or family history of mitochondrial disease