NCT00319215已完成1 期
A Study to Investigate the Residual Effects of Ramelteon (8 mg), Zopiclone (7.5 mg) and Placebo on Actual Driving, Memory, Psychomotor Performance and Mood
Utrecht Institute for Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
研究概览
简要总结
The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.
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
- 是
入选标准
- •The subject is male or female, 21 - 55 years of age, inclusive
- •The subject is capable of understanding and complying with the protocol requirements.
- •The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
- •The subject, if female, is non-pregnant and non-lactating.
- •Possession of a valid driver's license for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
- •An SDLP level at the end of the driving test of the dress rehearsal that does not exceed 24 cm. This dress rehearsal is performed at Visit 1.
排除标准
- •The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
- •The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of double-blind study medication, whichever is longer.
- •5.History or presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, respiratory, neurological or psychiatric disease 6.History of primary insomnia (DSM IV-TR criteria) within the past 6 months. 7.The subject has used any medication with psychotropic effects (e.g. antidepressants, anxiolytics, antihistamines) within 30 days of the initial visit.
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
Standard Deviation of Speed (SDS)
次要结局
- Mean Speed (MS)
- Mean Lateral Position (MLP)
- Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
- Sternberg memory scanning test: reaction time and % errors
- Tracking task: RMS (tracking error)
- Divided attention test: RMS,reaction time and % errors
- DSST: number of copied symbols
研究者
研究点 (1)
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