Last reviewed · How we verify
NCT03863366
Effects of Acute Prucalopride Administration in Healthy Volunteers
NA trial testing Prucalopride in Molecular Mechanisms of Pharmacological Action in 41 participants. Completed in 8 August 2017.
8 August 2017
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 41 |
| Start date | 7 February 2017 |
| Primary completion | 8 August 2017 |
| Estimated completion | 8 August 2017 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Prucalopride — full drug profile →
- Placebo
Conditions studied
- Molecular Mechanisms of Pharmacological Action — all drugs for Molecular Mechanisms of Pharmacological Action →
- Depression — all drugs for Depression →
- Depressive Disorder — all drugs for Depressive Disorder →
- Mood Disorders — all drugs for Mood Disorders →
Sponsor
University of Oxford
Who can join
Adults 18 to 40, any sex, with Molecular Mechanisms of Pharmacological Action or Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03863366
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Prucalopride
Trials testing the same drug.
- NCT05455359 — Gastrointestinal Dysmotility on Aspiration Risk · Phase 4 · recruiting
- NCT06883175 — Evolution of the Chicago Classification: Bridging Physiology and Mechanics · NA · recruiting
- NCT05496179 — The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients · Phase 1, PHASE2 · completed
- NCT05377619 — Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial · Phase 1, PHASE2 · completed
- NCT05220228 — Prucalopride and Cognition in Recovered Depression · NA · completed
Other recruiting trials for Molecular Mechanisms of Pharmacological Action
Currently open trials in the same condition.
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT06511908 — Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resi · Phase 2 · recruiting
- NCT06462196 — Natural History of Depression, Bipolar Disorder and Suicide Risk · recruiting
- NCT04572451 — Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanom · Phase 1 · recruiting
Other University of Oxford trials
Trials by the same sponsor.
- NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 ) · Phase 2 · not yet recruiting
- NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
- NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
- NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
- NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03863366 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oxford
- Last refreshed: 5 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03863366.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing