Trials / Completed
CompletedNCT03572790
Effects of Seven Day Prucalopride Administration in Healthy Volunteers
The Effect of Seven Day Prucalopride Administration on Emotional Processing in Healthy Volunteers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Prucalopride | 1mg prucalopride capsule, once daily for seven days |
| OTHER | Placebo | Lactose placebo capsule, once daily for seven days |
Timeline
- Start date
- 2018-06-11
- Primary completion
- 2019-05-17
- Completion
- 2019-05-17
- First posted
- 2018-06-28
- Last updated
- 2022-11-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03572790. Inclusion in this directory is not an endorsement.