Effects of Acute Prucalopride Administration in Healthy Volunteers

Not Applicable

Completed

• Conditions: Mood Disorders; Mental Disorder; Molecular Mechanisms of Pharmacological Action; Antidepressive Agents; Depression; Depressive Disorder; Cognition
• Interventions: Other: Placebo; Drug: Prucalopride

• Registration Number: NCT03863366
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-07
• Primary Completion: 2017-08-08
• Study Completion: 2017-08-08
• Study First Submitted: 2019-02-26
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-01
• Last Update Submitted: 2019-03-01
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Lactose placebo capsule
Prucalopride	Prucalopride	1mg prucalopride capsule

Primary Outcome Measures

Name	Time	Method
Recognition of positive and negative facial expressions	Day 1: 2-5 hours post drug administration	Accuracy to identify positive vs. negative facial expressions of emotion on the FERT

Secondary Outcome Measures

Name	Time	Method
Recall of emotional words	Day 1: 2-5 hours post drug administration	Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Recognition of emotional words	Day 1: 2-5 hours post drug administration	Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task
Attentional vigilance to emotional faces	Day 1: 2-5 hours post drug administration	Attentional vigilance to fearful and happy faces in the FDOT task
Reward and loss sensitivity	Day 1: 2-5 hours post drug administration	Proportion of participants on each trial that chose the correct (high probability) symbol in the win condition, and the incorrect (high probability) symbol in the loss condition of the PILT task
Working memory performance	Day 1: 2-5 hours post drug administration	Mean accuracy and reaction time on 1-back, 2-back and 3-back conditions compared with 0-back condition on the N-back task
Recall of words Auditory Verbal Learning Task (AVLT)	Day 1: 2-5 hours post drug administration	Number of items correctly and incorrectly recalled across blocks
Contextual learning	Day 1: 2-5 hours post drug administration	Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task

Trial Locations

Locations (1)

University of Oxford; 🇬🇧 Oxford, United Kingdom