Double-Blind, Placebo-Controlled Study of Depakote (Divalproex Sodium) in Children With Temper Outbursts and Severe Mood Swings
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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- •Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant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
排除标准
- •Meets criteria for pervasive developmental disorder or childhood schizophrenia
- •Seizure or other neurologic disturbance
- •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
结局指标
主要结局
Reduction in symptoms of explosive mood disorder; measured throughout the study and at Week 12
次要结局
未报告次要终点