The Effect of Seven Day Fenfluramine Administration on Cognition in Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Auditory Verbal Learning Task
研究概览
简要总结
In this study, the investigators will investigate the cognitive effects of fenfluramine, a drug that directly stimulates the release of serotonin in the brain and positively modulates σ1 function. The investigators will use fenfluramine to assess the cognitive effects of modulating serotonin and σ1 function in healthy volunteers using a battery of cognitive tasks that measure learning and memory, executive functioning, reward processing, and emotional processing. The study design is double-blind, and participants will be randomised to either seven days of fenfluramine or placebo administration. All participants will attend two screening visits to assess eligibility. There are two main study visits; during the first, participants will undertake cognitive tasks and questionnaires before taking the initial study dose. One the second study visit, participants will once again complete these tasks and questionnaires after a week of fenfluramine/placebo administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant, Data Collectors, Outcomes Assessor
入排标准
- 年龄范围
- 18 Years 至 22 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 research
- •Not currently taking any medications (except the contraceptive pill)
- •Aged 18-22 years
- •Male or female
- •Sufficiently fluent English to understand and complete the task
- •Body Mass Index above 18-30
- •Weight of 40-75kg
排除标准
- •Current pregnancy (as determined by urine pregnancy test taken during Screening and First Dose Visit) or breast feeding
- •Any past or current Axis 1 DSM-V psychiatric disorder
- •Clinically significant abnormal values for liver function tests, clinical chemistry, urine drug screen, blood pressure measurement and ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- •History of, or current medical conditions which, in the opinion of the investigator, may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological conditions
- •Current or past history of drug or alcohol dependency
- •Current or past use of 3,4-Methylenedioxymethamphetamine (MDMA)
- •Use of recreational drugs (e.g. cannabis, cocaine, amphetamines) within past 3 months
- •Participation in a study which uses the same computer tasks as those in the present study (determined by asking participants about previous studies participated in during screening)
- •Participation in a study that involves the use of a medication within the last three months
- •Smoking > 5 cigarettes per day
- •Typically drinks > 6 caffeinated drinks per day (e.g. tea, coffee, coca cola, Red Bull)
- •Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator
研究组 & 干预措施
Fenfluramine
Drug: Fenfluramine - 15mg twice daily oral solution for seven days
干预措施: Fenfluramine (Drug)
Placebo
Placebo - 15mg twice daily oral solution for seven days
干预措施: Placebo (Other)
结局指标
主要结局
Change in Auditory Verbal Learning Task
时间窗: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Accuracy on AVLT (number of items recalled across blocks)
Change in Go/No-Go Task performance
时间窗: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Accuracy on the Go/No-Go task
Change in N-back task performance
时间窗: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
Accuracy on the N-back task
次要结局
- Changes in reward sensitivity(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
- Changes in visual search ability(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
- Changes in recognition of emotional facial expressions(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
- Changes in recall of emotional words(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
- Changes in visual short term memory on the Oxford Memory Test (OMT)(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
- Changes in categorisation of emotional words(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
- Changes in control measures of subjective state(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
- Changes in recognition of emotional words(Immediately before initial dose (Day 1) and immediately before final visit (Day 7))
研究者
Catherine Harmer
Prof Catherine Harmer
University of Oxford