Acute Effects of Modafinil on Brain Resting State Networks in Young Healthy Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Acute effects of modafinil on brain resting state networks in young healthy subjects
研究概览
简要总结
There is growing debate on the use of drugs that can promote cognitive enhancement. Amphetamine-like drugs have been employed as cognitive enhancers, but all of them have important side effects and may induce addiction. In our study, we will investigate the use of modafinil which, in recent years, has been proposed as cognitive enhancer. Modafinil appears to have less side effects compared to amphetamine-like drugs and we will analyzed whether the drug can influence cognitive performances and the brain resting state network activity of healthy young subjects.
详细描述
Subjects will be included in a double-blind, placebo-controlled study in which a single dose (100 mg) of modafinil will be administered. Both groups will be, before and three hours after administration of drug or placebo, tested for neuropsychological performances with the Raven's Advanced Progressive Matrices II set (APM).
Resting state functional magnetic resonance (rs-fMRI) will be also employed, before and after three hours, to study changes in the activity of resting state brain networks. Finally, with Diffusion Tensor Imaging (DTI) we will evaluate the structural connectivity of the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •subjects do not meet the criteria for exclusion
排除标准
- •current signs of psychiatric, neurological or medical (hypertension, cardiac disorders, epilepsy) conditions as determined by the Millon test and by clinical examination;subjects showing visual or motor impairments. All subjects taking any psychoactive drug or having a history of alcohol abuse.
研究组 & 干预措施
Placebo
Study subjects received, in a double blind fashion, a placebo pill identical to the drug.
干预措施: Placebo (Drug)
Modafinil
Modafinil (Provigil), a drug on the market since 1997, is employed for the treatment of narcolepsy and other sleep disorders. In recent years, modafinil has also been used off-label to treat cognitive dysfunction in psychiatric disorders such as schizophrenia and Attention Deficit/Hyperactivity Disorder (ADHD).
Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil.
干预措施: Modafinil (Drug)
结局指标
主要结局
Acute effects of modafinil on brain resting state networks in young healthy subjects
时间窗: within one week
次要结局
未报告次要终点
研究者
Roberto Esposito
MD,Phd
Università degli Studi 'G. d'Annunzio' Chieti e Pescara