Effects of Acute Prucalopride Administration in Healthy Volunteers

The Effect of a Single Dose of Prucalopride on Emotional Processing in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Depression; Mood Disorders; Molecular Mechanisms of Pharmacological Action; Mental Disorder; Cognition; Antidepressive Agents
• Intervention / Treatment: Drug: Prucalopride; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7JX
    • University of Oxford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prucalopride; 1mg prucalopride capsule	Drug: Prucalopride; 1mg prucalopride tablet, encapsulated in white capsule; Other Names: Resolor
Placebo Comparator: Placebo; Lactose placebo capsule	Other: Placebo; Lactose placebo tablet, encapsulated in white capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall of emotional words	Number of positive and negative words correctly (and incorrectly) recalled in the EREC task	Day 1: 2-5 hours post drug administration
Recognition of emotional words	Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task	Day 1: 2-5 hours post drug administration
Attentional vigilance to emotional faces	Attentional vigilance to fearful and happy faces in the FDOT task	Day 1: 2-5 hours post drug administration
Recall of words Auditory Verbal Learning Task (AVLT)	Number of items correctly and incorrectly recalled across blocks	Day 1: 2-5 hours post drug administration
Reward and loss sensitivity	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	Day 1: 2-5 hours post drug administration
Working memory performance	Mean accuracy and reaction time on 1-back, 2-back and 3-back conditions compared with 0-back condition on the N-back task	Day 1: 2-5 hours post drug administration
Contextual learning	Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task	Day 1: 2-5 hours post drug administration

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Susannah E Murphy, DPhil, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): August 8, 2017
• Study Completion (Actual): August 8, 2017

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Emotional Processing; Prucalopride; Resolor; 5-HT4
• Additional Relevant MeSH Terms: Pathologic Processes; Depressive Disorder; Disease; Mental Disorders; Mood Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Laxatives; Serotonin 5-HT4 Receptor Agonists; Prucalopride
• Other Study ID Numbers: Acute_pruc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No