NCT02456454已完成3 期
Placebo Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Young Mania Rating Scale
研究概览
简要总结
Controlled trial of the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
详细描述
The objective of this study was to study the efficacy and safety of valproate, versus risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Risperidone
Experimental
Risperidone, PO 0.25-2 mg/day
干预措施: Risperidone (Drug)
Valproic
Experimental
Valproic Acid PO to achieve plasma levels of 85-100
干预措施: Valproic Acid (Drug)
Placebo
Placebo Comparator
Liquid placebo PO matched for color and taste.
干预措施: Placebo (Drug)
结局指标
主要结局
Young Mania Rating Scale
时间窗: 6 weeks
Young Mania Rating Scale
次要结局
- Clinical Global Improvement Scale(6 weeks)
研究者
Robert Kowatch
MD
Nationwide Children's Hospital
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