An interventional study of Prucalopride and Placebo in Molecular Mechanisms of Pharmacological Action, Depression and Depressive Disorder, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by University of Oxford · Not applicable, Interventional, and Basic science
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 41 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
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Exclusion Criteria:
1mg prucalopride capsule
Drug: Prucalopride
Lactose placebo capsule
Other: Placebo
1mg prucalopride tablet, encapsulated in white capsule
Also known as: Resolor
Lactose placebo tablet, encapsulated in white capsule
Recognition of positive and negative facial expressions
Accuracy to identify positive vs. negative facial expressions of emotion on the FERT
Time frame: Day 1: 2-5 hours post drug administration
Recall of emotional words
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Time frame: Day 1: 2-5 hours post drug administration
Recognition of emotional words
Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task
Time frame: Day 1: 2-5 hours post drug administration
Attentional vigilance to emotional faces
Attentional vigilance to fearful and happy faces in the FDOT task
Time frame: Day 1: 2-5 hours post drug administration
Recall of words Auditory Verbal Learning Task (AVLT)
Number of items correctly and incorrectly recalled across blocks
Time frame: Day 1: 2-5 hours post drug administration
Reward and loss sensitivity
Proportion of participants on each trial that chose the correct (high probability) symbol in the win condition, and the incorrect (high probability) symbol in the loss condition of the PILT task
Time frame: Day 1: 2-5 hours post drug administration
Working memory performance
Mean accuracy and reaction time on 1-back, 2-back and 3-back conditions compared with 0-back condition on the N-back task
Time frame: Day 1: 2-5 hours post drug administration
Contextual learning
Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task
Time frame: Day 1: 2-5 hours post drug administration
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Oxford