Mood Disorders Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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