Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Battery of EEG measurements
研究概览
简要总结
To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The subject has a normal resting EEG at screening visit
- •The subject is able to perform tasks with an auditory stimulus
- •The subject is not visually impaired - normal prescription glasses are accepted
- •The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.
排除标准
- •The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Vortioxetine 10 mg
encapsulated tablets; 3 daily doses in each treatment period; orally
干预措施: Vortioxetine 10 mg (Drug)
Vortioxetine 20 mg
encapsulated tablets; 3 daily doses in each treatment period; orally
干预措施: Vortioxetine 20 mg (Drug)
Escitalopram 15 mg
encapsulated tablets; 3 daily doses in each treatment period; orally
干预措施: Escitalopram 15 mg (Drug)
Placebo
capsules; 3 daily doses in each treatment period; orally
干预措施: Placebo (Drug)
结局指标
主要结局
Battery of EEG measurements
时间窗: The EEG task battery will be conducted on Days -1 and starting 6 hours post-dose on Days 1 and 3 of each treatment period.
* Peak amplitude and latency of P300 * AUC of qEEG power spectral bands delta, theta, alpha, beta and gamma * AUC of evoked gamma power spectral band * Peak amplitude and latency of N200 * Peak amplitude and latency of error related negativity * Peak amplitudes and latencies in the evoked responses during successful versus non-successful encoding in the verbal memory task between treatments
次要结局
未报告次要终点