A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- State anxiety
研究概览
简要总结
The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivity disorder.
Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of age.
Structure: the study is a randomized double blind crossover study. The subjects will complete a continuous performance test, the cambridge neuropsychological test automated Battery, before and after given methylphenidate or placebo on the first day of the study. On the second day of the study, the subjects will receive either methylphenidate or placebo based on what was given on the first day of the study and they will complete the same task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attention deficit and hyperactivity disorder
- •Children aged 8-18 years
排除标准
- •Pervasive developmental disorder
- •Schizophrenia
- •Bipolar disorder
- •Current depressive episode
- •Current Anxiety disorder
- •Drug use during the past 6 months
研究组 & 干预措施
Methylphenidate
Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test.
干预措施: Methylphenidate (Drug)
结局指标
主要结局
State anxiety
时间窗: 1 year
State anxiety will be measured by the Spielberger's state anxiety inventory
次要结局
- Patient's perspective(1 year)
- Cognitive function(1 year)
研究者
Maya Kritchman Lupo
Resident
Shalvata Mental Health Center