Status:
COMPLETED
Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Mood Disorders
Eligibility:
All Genders
7-11 years
Phase:
PHASE2
Brief 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.
Detailed Description
Depakote has been used to treat seizures in children for more than 20 years. The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) in treating children with tempe...
Eligibility Criteria
Inclusion
- 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- Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant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
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00217932
Start Date
September 1 2000
End Date
August 1 2005
Last Update
January 12 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032