Effects of Seven Day Prucalopride Administration in Healthy Volunteers

Depression Clinical Trial

Official title:

The Effect of Seven Day Prucalopride Administration on Emotional Processing in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572790
• Other study ID #: Pruc_7d
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: November 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study

• Male or female

• Aged 18-40 years

• Sufficiently fluent English to understand and complete the task

• Right handed

• Body Mass Index in the range of 18-30

• Not currently taking any medications (except the contraceptive pill)

Exclusion Criteria:

• Not fluent in English

• Any past or current Axis 1 DSM-V psychiatric disorder

• Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)

• Current usage of any medication that will influence the MRI scan

• Current or past history of drug or alcohol dependency

• Currently pregnant or breastfeeding

• Study visits due to take place during the pre-menstrual week (female participants asked details of their menstrual cycle to schedule the study outside this week)

• Not right handed

• Body Mass Index outside the range of 18-30

• History of cardiac, thyroid, or liver problems

• An autoimmune disorder

• Current, or a history of, gastro-intestinal disorder or irritable bowel syndrome

• Epilepsy

• Known lactate deficiency or any other problem absorbing lactose, galactose, or glucose

• Participation in a study which uses the same computer tasks as those used in the present study

• Participation in a study that involves the use of a medication within the last three months

• Smoker > 5 cigarettes per day

• Typically drinks > 6 caffeinated drinks per day

• Any contraindication to MRI scanning (e.g. metal objects in the body, pacemakers, significant claustrophobia)

Related Conditions & MeSH terms

• Antidepressive Agents
• Cognition
• Depression
• Depressive Disorder
• Disease
• Mental Disorders
• Molecular Mechanisms of Pharmacological Action
• Mood Disorders

Intervention

Drug:
• Prucalopride
1mg prucalopride capsule, once daily for seven days

Other:
• Placebo
Lactose placebo capsule, once daily for seven days

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recognition of positive and negative facial expressions	Accuracy to recognise positive and negative facial expressions (anger, disgust, fear, happy , sad, surprise)	Completed on Day 7
Primary	Performance on Auditory Verbal Learning Task (AVLT)	Accuracy on AVLT (number of items recalled across blocks)	Completed on Day 7
Secondary	Neural response to emotional faces	Blood Oxygen Level Dependent (BOLD) signal in a network including the amygdala, anterior cingulate cortex, and orbitofrontal cortex	Completed on Day 6
Secondary	Neural response to novel vs repeated scenes	BOLD signal to scenes that have previously been seen compared to novel scenes in a network including the hippocampus and parahippocampal regions	Completed on Day 6
Secondary	Reward sensitivity	Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task (PILT)	Completed on Day 7
Secondary	Categorisation, recall, and recognition of emotional words	Accuracy and reaction time to categorise positive and negative descriptor words; number of words correctly (hits) and incorrectly (false alarms) recalled and recognised	Completed on Day 7
Secondary	Vigilance to fearful and happy faces on the Facial Dot Probe Task (FDOT)	Vigilance derived from reaction time	Completed on Day 7
Secondary	Resting state connectivity	Resting state connectivity (using resting state fMRI) including the default mode network, salience network, affective network, and limbic system, identified via correlations between spontaneous BOLD activity in spatially independent regions while participants are not actively engaged in an experimental task	Completed on Day 6
Secondary	Relative and global cerebral blood flow	Arterial spin labelling (ASL) global and cerebral blood flow	Completed on Day 6
Secondary	Visual short term memory on the Oxford Memory Test (OMT)	Proportion of correct probe selections, absolute error for probe location, reaction time, and proportion of misbinding errors	Completed on Day 7