Effects of Seven Day Prucalopride Administration in Healthy Volunteers

NCT03572790 | Completed

• 1 other identifier: Pruc_7d
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

5-HT4; Prucalopride; Resolor; Functional Magnetic Resonance Imaging (fMRI); Emotional Processing; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

• Performance on Auditory Verbal Learning Task (AVLT)

  Accuracy on AVLT (number of items recalled across blocks)

  Completed on Day 7

Secondary Outcomes (8)

• Neural response to emotional faces

  Completed on Day 6

• Neural response to novel vs repeated scenes

  Completed on Day 6

• Reward sensitivity

  Completed on Day 7

• Categorisation, recall, and recognition of emotional words

  Completed on Day 7

• Vigilance to fearful and happy faces on the Facial Dot Probe Task (FDOT)

  Completed on Day 7

Study Arms (2)

Prucalopride

EXPERIMENTAL

Drug: Prucalopride

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Prucalopride DRUG

1mg prucalopride capsule, once daily for seven days

Also known as: Resolor

Prucalopride

Placebo OTHER

Lactose placebo capsule, once daily for seven days

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX3 7JX, United Kingdom

Location

Related Publications (1)

• de Cates AN, Martens MAG, Wright LC, Gibson D, Spitz G, Gould van Praag CD, Suri S, Cowen PJ, Murphy SE, Harmer CJ. 5-HT4 Receptor Agonist Effects on Functional Connectivity in the Human Brain: Implications for Procognitive Action. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Nov;8(11):1124-1134. doi: 10.1016/j.bpsc.2023.03.014. Epub 2023 Apr 23.

  PMID: 37098409 DERIVED

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 once daily for seven days. Participants in the placebo group will receive a lactose placebo once daily for seven days. 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: June 7, 2018
• First Posted: June 28, 2018
• Study Start: June 11, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)