Trials / Completed
CompletedNCT03863366
Effects of Acute Prucalopride Administration in Healthy Volunteers
The Effect of a Single Dose of Prucalopride on Emotional Processing in Healthy Volunteers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Prucalopride | 1mg prucalopride tablet, encapsulated in white capsule |
| OTHER | Placebo | Lactose placebo tablet, encapsulated in white capsule |
Timeline
- Start date
- 2017-02-07
- Primary completion
- 2017-08-08
- Completion
- 2017-08-08
- First posted
- 2019-03-05
- Last updated
- 2019-03-05
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03863366. Inclusion in this directory is not an endorsement.