MedTrace Logo

Effects of Seven Day Prucalopride Administration in Healthy Volunteers

NCT03572790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-11-18

No results posted yet for this study

Summary

This study will investigate whether seven days administration of the serotonin receptor subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and neural activity 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 seven days administration of either prucalopride (1mg daily) or placebo. All participants will come for a Screening visit, Research Visit One (including an MRI scan) and Research Visit Two (including measures of emotional processing and non-emotional cognition). The primary study hypothesis is that seven-day prucalopride administration will have positive effects on emotional processing and reward sensitivity. A secondary hypothesis is that seven-day prucalopride administration will alter non-emotional cognition. Finally, the study will test the hypothesis that seven day prucalopride administration will alter neural activity during an emotional faces task and a memory task.

Conditions

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

Interventions

DRUG

Prucalopride

1mg prucalopride capsule, once daily for seven days

OTHER

Placebo

Lactose placebo capsule, once daily for seven days

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
2018-06-11
Primary Completion
2019-05-17
Completion
2019-05-17

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 NCT03572790 on ClinicalTrials.gov