Clinical trial NCT03863366: Effects of Acute Prucalopride Administration in Healthy Volunteers
Official title: The Effect of a Single Dose of Prucalopride on Emotional Processing in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molecular Mechanisms of Pharmacological Action
Depression
Depressive Disorder
Mood Disorders
Mental Disorder
Antidepressive Agents
Cognition
Keywords: 5-HT4
Prucalopride
Resolor
Emotional Processing
Healthy Volunteers
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of two groups (prucalopride or placebo). Participants in the prucalopride group will receive 1mg of the drug. Participants in the placebo group will receive a lactose placebo. Note that the study is not assessing the safety or efficacy of prucalopride, rather it is using prucalopride to assess the behavioural and neural effects of 5-HT4 partial agonists.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate whether administration of a single dose of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and non-emotional cognition 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 a single dose of either prucalopride (1mg) or placebo. All participants will come for a Screening Visit to ensure their suitability for the study. If they meet study criteria, they will be invited to a Research Visit, where they will receive the study medication and wait for two hours while the drug reaches peak levels. After two hours they will be asked to complete a series of computer-based tasks measuring emotional, non-emotional cognitive processing, and reward processing. The primary study hypothesis is that acute prucalopride administration will have positive effects on processing facial expressions of emotion. Secondary hypotheses are that acute prucalopride administration will affect other measures of emotional processing, and non-emotional cognition.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 18-40 years
* Willing and able to give informed consent for participation in the study
* Sufficiently fluent English to understand and complete the task

Exclusion Criteria:

* Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)
* Any past or current Axis 1 DSM-IV psychiatric disorder
* Significant medical condition
* Current or past gastro-intestinal disorder or irritable bowel syndrome
* Current pregnancy or breastfeeding
* Known lactate deficiency or any other problem absorbing lactose, galactose or glucose
* Current or past history of drug or alcohol dependency
* Participation in a psychological or medical study involving the use of medication within the last 3 months
* Previous participation in a study using the same, or similar, emotional processing tasks
* Smoker \> 5 cigarettes per day
* Typically drinks \> 6 caffeinated drinks per day

Primary outcomes:
measure: Recognition of positive and negative facial expressions
timeFrame: Day 1: 2-5 hours post drug administration
Secondary outcomes:
measure: Recall of emotional words
timeFrame: Day 1: 2-5 hours post drug administration
measure: Recognition of emotional words
timeFrame: Day 1: 2-5 hours post drug administration
measure: Attentional vigilance to emotional faces
timeFrame: Day 1: 2-5 hours post drug administration
measure: Recall of words Auditory Verbal Learning Task (AVLT)
timeFrame: Day 1: 2-5 hours post drug administration
measure: Reward and loss sensitivity
timeFrame: Day 1: 2-5 hours post drug administration
measure: Working memory performance
timeFrame: Day 1: 2-5 hours post drug administration
measure: Contextual learning
timeFrame: Day 1: 2-5 hours post drug administration
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: University of Oxford
name: Susannah E Murphy, DPhil
role: PRINCIPAL_INVESTIGATOR
References: