The Effects of Single-dose Administration of a Novel Selective alpha2c Antagonist on Emotional and Cognitive Processing in Healthy Volunteers: an fMRI Investigation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory
研究概览
简要总结
The aim of the present study is to investigate changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with emotional and working memory during task performance after single-dose administration of a novel selective alpha2c adrenoceptor antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741 affects connectivity between brain areas in rest, as measured using fMRI, and cognitive performance in the sample under investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good command of English language
- •right handedness
- •normal or corrected-to-normal vision
排除标准
- •personal history or active presence of psychiatric conditions
- •usage of psychotropic medication within the past 3 months
- •pregnancy or breast-feeding status
- •systolic blood pressure < 90 mmHg or > 140 mmHg at screening visit
- •diastolic blood pressure < 50 mmHg or > 90 mmHg at screening visit
- •resting heart rate < 45 beats/minute or > 100 beats/minute at screening visit
- •active presence of medical condition at physical examination
- •history of major traumatic brain injury
- •any other contraindication to MRI of the brain
- •use of psychoactive substances incl. alcohol in 24 hours prior to test session
研究组 & 干预措施
High-dosage (60mg) ORM-12741
6 x 10 mg ORM-12741 immediate release capsules in a single dose
干预措施: ORM-12741 (Drug)
Low-dosage (10mg) ORM-12741
1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose
干预措施: ORM-12741 (Drug)
Placebo
6 x placebo capsules in a single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory
时间窗: 1-1.5 hours post medication intake
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory
时间窗: 1-1.5 hours post medication intake
次要结局
- Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state(1.5-2 hours post medication intake)
- Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)(1-3 hours post medication intake)
研究者
Prof. Dan J. Stein
Prof.
University of Cape Town