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临床试验/NCT03616717
NCT03616717已完成4 期

Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年10月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
23
试验地点
1
主要终点
Motivation Signal

研究概览

简要总结

The effects of modafinil on measures of brain electrical activity will be tested.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

University of California, San Diego Experimental Pharmacy randomizes dose order and provides masked pills

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

modafinil 100 mg

Active Comparator

Drug: modafinil, Provigil, Alertec, Modavigil

Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.

干预措施: Modafinil (Drug)

modafinil 200 mg

Active Comparator

Drug: modafinil, Provigil, Alertec, Modavigil

Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.

干预措施: Modafinil (Drug)

placebo

Placebo Comparator

Drug: modafinil, Provigil, Alertec, Modavigil

Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.

干预措施: placebo (Drug)

结局指标

主要结局

Motivation Signal

时间窗: 1 year

Parietal EEG alpha power peak in first - final step toward breakpoint

Reward Positivity

时间窗: 1 year

Frontal alpha power by block in the probabilistic learning task

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jared W. Young

Principal Investigator

University of California, San Diego

研究点 (1)

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