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Completed

NCT Number: NCT03572790

Effects of Seven Day Prucalopride Administration in Healthy Volunteers

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.

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Key information

Conditions

Molecular Mechanisms of Pharmacological Action Antidepressive Agents Behavior Behavioral Symptoms Cognition Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oxford

Oxford, OX3 7JX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

prucalopride

Drug

1mg prucalopride capsule, once daily for seven days

Other names: Resolor

Placebo

Other

Lactose placebo capsule, once daily for seven days

Primary outcomes

  1. Recognition of positive and negative facial expressions

    Time frame: Completed on Day 7

    Accuracy to recognise positive and negative facial expressions (anger, disgust, fear, happy , sad, surprise)

  2. Performance on Auditory Verbal Learning Task (AVLT)

    Time frame: Completed on Day 7

    Accuracy on AVLT (number of items recalled across blocks)

Secondary outcomes

  1. Neural response to emotional faces

    Time frame: Completed on Day 6

    Blood Oxygen Level Dependent (BOLD) signal in a network including the amygdala, anterior cingulate cortex, and orbitofrontal cortex

  2. Neural response to novel vs repeated scenes

    Time frame: Completed on Day 6

    BOLD signal to scenes that have previously been seen compared to novel scenes in a network including the hippocampus and parahippocampal regions

  3. Reward sensitivity

    Time frame: Completed on Day 7

    Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task (PILT)

  4. Categorisation, recall, and recognition of emotional words

    Time frame: Completed on Day 7

    Accuracy and reaction time to categorise positive and negative descriptor words; number of words correctly (hits) and incorrectly (false alarms) recalled and recognised

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

    Time frame: Completed on Day 7

    Vigilance derived from reaction time

  6. Resting state connectivity

    Time frame: Completed on Day 6

    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

  7. Relative and global cerebral blood flow

    Time frame: Completed on Day 6

    Arterial spin labelling (ASL) global and cerebral blood flow

  8. Visual short term memory on the Oxford Memory Test (OMT)

    Time frame: Completed on Day 7

    Proportion of correct probe selections, absolute error for probe location, reaction time, and proportion of misbinding errors

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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