drugset / Trial / NCT03572790

Effects of Seven Day Prucalopride Administration in Healthy Volunteers

NCT03572790

Completed 50 enrolled University of Oxford
RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Prucalopride Small molecule 1 mg

Indications