Effects of Acute Prucalopride Administration in Healthy Volunteers

Depression Clinical Trial

Official title:

The Effect of a Single Dose of Prucalopride on Emotional Processing in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863366
• Other study ID #: Acute_pruc
• Status: Completed
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: August 8, 2017

Study information

• Verified date: March 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male or female

• Aged 18-40 years

• Willing and able to give informed consent for participation in the study

• Sufficiently fluent English to understand and complete the task

Exclusion Criteria:

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

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

• Significant medical condition

• Current or past gastro-intestinal disorder or irritable bowel syndrome

• Current pregnancy or breastfeeding

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

• Current or past history of drug or alcohol dependency

• Participation in a psychological or medical study involving the use of medication within the last 3 months

• Previous participation in a study using the same, or similar, emotional processing tasks

• Smoker > 5 cigarettes per day

• Typically drinks > 6 caffeinated drinks per day

Related Conditions & MeSH terms

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

Intervention

Drug:
• Prucalopride
1mg prucalopride tablet, encapsulated in white capsule

Other:
• Placebo
Lactose placebo tablet, encapsulated in white capsule

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 identify positive vs. negative facial expressions of emotion on the FERT	Day 1: 2-5 hours post drug administration
Secondary	Recall of emotional words	Number of positive and negative words correctly (and incorrectly) recalled in the EREC task	Day 1: 2-5 hours post drug administration
Secondary	Recognition of emotional words	Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task	Day 1: 2-5 hours post drug administration
Secondary	Attentional vigilance to emotional faces	Attentional vigilance to fearful and happy faces in the FDOT task	Day 1: 2-5 hours post drug administration
Secondary	Recall of words Auditory Verbal Learning Task (AVLT)	Number of items correctly and incorrectly recalled across blocks	Day 1: 2-5 hours post drug administration
Secondary	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	Day 1: 2-5 hours post drug administration
Secondary	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	Day 1: 2-5 hours post drug administration
Secondary	Contextual learning	Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task	Day 1: 2-5 hours post drug administration

External Links

•   Psychopharmacology and Emotion Research Laboratory