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Effects of Acute Prucalopride Administration in Healthy Volunteers

NCT03863366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-03-05

No results posted yet for this study

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.

Conditions

  • Molecular Mechanisms of Pharmacological Action
  • Depression
  • Depressive Disorder
  • Mood Disorders
  • Mental Disorder
  • Antidepressive Agents
  • Cognition

Interventions

DRUG

Prucalopride

1mg prucalopride tablet, encapsulated in white capsule

OTHER

Placebo

Lactose placebo tablet, encapsulated in white capsule

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Susannah E Murphy, DPhil · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-07
Primary Completion
2017-08-08
Completion
2017-08-08

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863366 on ClinicalTrials.gov