Effects of Acute Prucalopride Administration in Healthy Volunteers

NCT03863366 | Completed

• 1 other identifier: Acute_pruc
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

5-HT4; Prucalopride; Resolor; Emotional Processing; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Recall of emotional words

  Day 1: 2-5 hours post drug administration

• Recognition of emotional words

  Day 1: 2-5 hours post drug administration

• Attentional vigilance to emotional faces

  Day 1: 2-5 hours post drug administration

• Recall of words Auditory Verbal Learning Task (AVLT)

  Day 1: 2-5 hours post drug administration

• Reward and loss sensitivity

  Day 1: 2-5 hours post drug administration

Study Arms (2)

Prucalopride

EXPERIMENTAL

1mg prucalopride capsule

Drug: Prucalopride

Placebo

PLACEBO COMPARATOR

Lactose placebo capsule

Other: Placebo

Interventions

Prucalopride DRUG

1mg prucalopride tablet, encapsulated in white capsule

Also known as: Resolor

Prucalopride

Placebo OTHER

Lactose placebo tablet, encapsulated in white capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX3 7JX, United Kingdom

Location

Related Links

• Psychopharmacology and Emotion Research Laboratory

MeSH Terms

Conditions

Depression; Depressive Disorder; Mood Disorders; Mental Disorders

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Susannah E Murphy, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 5, 2019
• Study Start: February 7, 2017
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)