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Effects of Seven Day Prucalopride Administration in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03572790
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
drsusannahmurphy, University of Oxford

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.

Condition or disease Intervention/treatment Phase
Molecular Mechanisms of Pharmacological Action Depression Depressive Disorder Mood Disorders Mental Disorders Antidepressive Agents Cognition Drug: Prucalopride Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Seven Day Prucalopride Administration on Emotional Processing in Healthy Volunteers
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Prucalopride Drug: Prucalopride
1mg prucalopride capsule, once daily for seven days
Other Name: Resolor

Placebo Comparator: Placebo Other: Placebo
Lactose placebo capsule, once daily for seven days




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572790


Contacts
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Contact: Susannah E Murphy, DPhil 01865 618313 ext +44 susannah.murphy@psych.ox.ac.uk
Contact: Lucy C Wright, MSc 01865 618319 ext +44 lucy.wright@psych.ox.ac.uk

Locations
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United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 7JX
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Susannah E Murphy, DPhil University of Oxford
  Study Documents (Full-Text)

Documents provided by drsusannahmurphy, University of Oxford:
Study Protocol  [PDF] May 16, 2019
Informed Consent Form  [PDF] June 5, 2018
Statistical Analysis Plan  [PDF] August 16, 2019


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Responsible Party: drsusannahmurphy, Senior Research Fellow, University of Oxford
ClinicalTrials.gov Identifier: NCT03572790     History of Changes
Other Study ID Numbers: Pruc_7d
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by drsusannahmurphy, University of Oxford:
5-HT4
Prucalopride
Resolor
Functional Magnetic Resonance Imaging (fMRI)
Emotional Processing
Healthy Volunteers

Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Prucalopride
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs