The Effect of Seven Day Prucalopride Administration on Emotional Processing in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recognition of positive and negative facial expressions
研究概览
简要总结
This study will investigate whether seven days administration of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and neural activity in healthy volunteers, compared to placebo administration. Using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. In a double-blind design, participants will be randomised to receive seven days administration of either prucalopride (1mg daily) or placebo. All participants will come for a Screening visit, Research Visit One (including an MRI scan) and Research Visit Two (including measures of emotional processing and non-emotional cognition). The primary study hypothesis is that seven-day prucalopride administration will have positive effects on emotional processing and reward sensitivity. A secondary hypothesis is that seven-day prucalopride administration will alter non-emotional cognition. Finally, the study will test the hypothesis that seven day prucalopride administration will alter neural activity during an emotional faces task and a memory task.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Male or female
- •Aged 18-40 years
- •Sufficiently fluent English to understand and complete the task
- •Right handed
- •Body Mass Index in the range of 18-30
- •Not currently taking any medications (except the contraceptive pill)
排除标准
- •Not fluent in English
- •Any past or current Axis 1 DSM-V psychiatric disorder
- •Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
- •Current usage of any medication that will influence the MRI scan
- •Current or past history of drug or alcohol dependency
- •Currently pregnant or breastfeeding
- •Study visits due to take place during the pre-menstrual week (female participants asked details of their menstrual cycle to schedule the study outside this week)
- •Not right handed
- •Body Mass Index outside the range of 18-30
- •History of cardiac, thyroid, or liver problems
- •An autoimmune disorder
- •Current, or a history of, gastro-intestinal disorder or irritable bowel syndrome
- •Known lactate deficiency or any other problem absorbing lactose, galactose, or glucose
- •Participation in a study which uses the same computer tasks as those used in the present study
- •Participation in a study that involves the use of a medication within the last three months
- •Smoker > 5 cigarettes per day
- •Typically drinks > 6 caffeinated drinks per day
- •Any contraindication to MRI scanning (e.g. metal objects in the body, pacemakers, significant claustrophobia)
研究组 & 干预措施
Prucalopride
干预措施: Prucalopride (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Recognition of positive and negative facial expressions
时间窗: Completed on Day 7
Accuracy to recognise positive and negative facial expressions (anger, disgust, fear, happy , sad, surprise)
Performance on Auditory Verbal Learning Task (AVLT)
时间窗: Completed on Day 7
Accuracy on AVLT (number of items recalled across blocks)
次要结局
- Vigilance to fearful and happy faces on the Facial Dot Probe Task (FDOT)(Completed on Day 7)
- Resting state connectivity(Completed on Day 6)
- Neural response to emotional faces(Completed on Day 6)
- Neural response to novel vs repeated scenes(Completed on Day 6)
- Reward sensitivity(Completed on Day 7)
- Categorisation, recall, and recognition of emotional words(Completed on Day 7)
- Relative and global cerebral blood flow(Completed on Day 6)
- Visual short term memory on the Oxford Memory Test (OMT)(Completed on Day 7)
研究者
drsusannahmurphy
Senior Research Fellow
University of Oxford