Effects of Acute Prucalopride Administration in Healthy Volunteers

University of Oxford

Status

Completed

Conditions

Antidepressive Agents

Mental Disorder

Molecular Mechanisms of Pharmacological Action

Cognition

Depression

Mood Disorders

Depressive Disorder

Treatments

Drug: Prucalopride

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03863366

Acute_pruc

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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