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

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Mood Disorders

Treatments

Drug: Divalproex Sodium (Depakote)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00217932

NIDA-00451-1

K02-00451-1

DPMC

Details and patient eligibility

About

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.

Full 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 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.

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

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Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant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