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

Completed · Phase 2

Conditions studied: Mood Disorders

In brief

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.

Key facts

Study ID

NCT00217932

Run by

National Institute on Drug Abuse (NIDA)

People needed

15

Starts

2000-09-01

Expected to finish

2005-08-01

Last updated by the study team

2017-01-12

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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• Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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