Effects of Acute Prucalopride Administration in Healthy Volunteers

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT03863366

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Molecular Mechanisms of Pharmacological Action Depression Depressive Disorder Mood Disorders Mental Disorder Antidepressive Agents Cognition	Drug: Prucalopride Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly allocated to one of two groups (prucalopride or placebo). Participants in the prucalopride group will receive 1mg of the drug. Participants in the placebo group will receive a lactose placebo. Note that the study is not assessing the safety or efficacy of prucalopride, rather it is using prucalopride to assess the behavioural and neural effects of 5-HT4 partial agonists.Participants will be randomly allocated to one of two groups (prucalopride or placebo). Participants in the prucalopride group will receive 1mg of the drug. Participants in the placebo group will receive a lactose placebo. Note that the study is not assessing the safety or efficacy of prucalopride, rather it is using prucalopride to assess the behavioural and neural effects of 5-HT4 partial agonists.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 7, 2017

Actual Primary Completion Date :

Aug 8, 2017

Actual Study Completion Date :

Aug 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prucalopride 1mg prucalopride capsule	Drug: Prucalopride 1mg prucalopride tablet, encapsulated in white capsule Other Names: Resolor
Placebo Comparator: Placebo Lactose placebo capsule	Other: Placebo Lactose placebo tablet, encapsulated in white capsule

Arm

Intervention/Treatment

Experimental: Prucalopride

1mg prucalopride capsule

Drug: Prucalopride

1mg prucalopride tablet, encapsulated in white capsule

Other Names:

Resolor

Placebo Comparator: Placebo

Lactose placebo capsule

Other: Placebo

Lactose placebo tablet, encapsulated in white capsule

Outcome Measures

Primary Outcome Measures

Recognition of positive and negative facial expressions [Day 1: 2-5 hours post drug administration]
Accuracy to identify positive vs. negative facial expressions of emotion on the FERT

Secondary Outcome Measures

Recall of emotional words [Day 1: 2-5 hours post drug administration]
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Recognition of emotional words [Day 1: 2-5 hours post drug administration]
Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task
Attentional vigilance to emotional faces [Day 1: 2-5 hours post drug administration]
Attentional vigilance to fearful and happy faces in the FDOT task
Recall of words Auditory Verbal Learning Task (AVLT) [Day 1: 2-5 hours post drug administration]
Number of items correctly and incorrectly recalled across blocks
Reward and loss sensitivity [Day 1: 2-5 hours post drug administration]
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
Working memory performance [Day 1: 2-5 hours post drug administration]
Mean accuracy and reaction time on 1-back, 2-back and 3-back conditions compared with 0-back condition on the N-back task
Contextual learning [Day 1: 2-5 hours post drug administration]
Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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