Official Title: “Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

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 temper outbursts and severe mood disorders.

This study will last 12 weeks. Participants will be randomly assigned to receive either 250 mg Depakote or placebo. The dose of medication will increase at the end of Week 1 to 500 mg of either depakote or placebo; participants will remain on this dose through Week 5. At Week 6, participants will cross-over and receive the other treatment (either depakote or placebo), which they will take through Week 12. Study visits will occur weekly and will include a physical exam, blood and urine tests, and self-reports of adverse events. In addition, caregivers will complete reports about mood swings throughout the study.

Intervention(s) in this Clinical Trial

• Drug: Divalproex Sodium (Depakote)

Primary Measures

• Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12

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• Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Stephen Donovan, MD Principal Investigator Columbia University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00217932

Study ID Number: NIDA-00451-1

ClinicalTrials.gov Identifier: NCT00217932

Health Authority: United States: Federal Government