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Completed

NCT Number: NCT03863366

Effects of Acute Prucalopride Administration in Healthy Volunteers

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.

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Key information

Conditions

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

  • 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

Treatment and study plan

prucalopride

Drug

1mg prucalopride tablet, encapsulated in white capsule

Other names: Resolor

Placebo

Other

Lactose placebo tablet, encapsulated in white capsule

Primary outcomes

  1. Recognition of positive and negative facial expressions

    Time frame: Day 1: 2-5 hours post drug administration

    Accuracy to identify positive vs. negative facial expressions of emotion on the FERT

Secondary outcomes

  1. Recall of emotional words

    Time frame: Day 1: 2-5 hours post drug administration

    Number of positive and negative words correctly (and incorrectly) recalled in the EREC task

  2. Recognition of emotional words

    Time frame: Day 1: 2-5 hours post drug administration

    Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task

  3. Attentional vigilance to emotional faces

    Time frame: Day 1: 2-5 hours post drug administration

    Attentional vigilance to fearful and happy faces in the FDOT task

  4. Recall of words Auditory Verbal Learning Task (AVLT)

    Time frame: Day 1: 2-5 hours post drug administration

    Number of items correctly and incorrectly recalled across blocks

  5. Reward and loss sensitivity

    Time frame: 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

  6. Working memory performance

    Time frame: 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

  7. Contextual learning

    Time frame: Day 1: 2-5 hours post drug administration

    Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2019
Registry last updated
Mar 5, 2019

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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