NCT00223561已完成4 期
A Double Blind, Placebo-Controlled Crossover Study to Determine the Effects of Methylphenidate on Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
Utrecht Institute for Pharmaceutical Sciences2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2003年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
研究概览
简要总结
The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.
详细描述
This study was set-up to examine the controversial issue whether or not it is safe to drive a car or not when treated with methylphenidate.
On-the-road driving tests during normal traffic are conducted to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.In addition, two laboratory tests are conducted to examine memory functioning and inhibitory control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult ADHD patient over 21 years old
- •valid driver's license for at least 3 years
- •treated with methylphenidate
- •written informed consent
排除标准
- •use of illicit drugs
- •use of drugs or having medical conditions known to affect driving ability
结局指标
主要结局
Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
次要结局
- Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position.
- Memory test: immediate & delayed word recall, delayed recognition.[single dose effects]
- Continuous Performance test: RT, %errors [single dose effects]
研究者
研究点 (2)
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