Molecular Mechanisms of Pharmacological ActionNCT03863366
Effects of Acute Prucalopride Administration in Healthy Volunteers
A study testing Prucalopride in people with Molecular Mechanisms of Pharmacological Action and Depression, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder
- What is being tested?
- Prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Feb 2017to 8 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Single Dose of Prucalopride on Emotional Processing 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.
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mood Disorders, Mental Disorder, Antidepressive Agents
- Being tested
- Prucalopride, Placebo
- Keywords
- 5-HT4, Prucalopride, Resolor, Emotional Processing, Healthy Volunteers
- Medical subject headings
- Depression, Depressive Disorder, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Resolor
1mg prucalopride tablet, encapsulated in white capsule
PlaceboOther
Lactose placebo tablet, encapsulated in white capsule
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride | Experimental | 1mg prucalopride capsule Receives: Drug: Prucalopride |
| Placebo | Placebo comparator | Lactose placebo capsule Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition of positive and negative facial expressions
Accuracy to identify positive vs. negative facial expressions of emotion on the FERT
Measured: Day 1: 2-5 hours post drug administration
Secondary outcomes (7)
Recall of emotional words
Number of positive and negative words correctly (and incorrectly) recalled in the EREC task
Measured: Day 1: 2-5 hours post drug administration
Recognition of emotional words
Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task
Measured: Day 1: 2-5 hours post drug administration
Attentional vigilance to emotional faces
Attentional vigilance to fearful and happy faces in the FDOT task
Measured: Day 1: 2-5 hours post drug administration
Recall of words Auditory Verbal Learning Task (AVLT)
Number of items correctly and incorrectly recalled across blocks
Measured: Day 1: 2-5 hours post drug administration
Reward and loss sensitivity
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
Measured: Day 1: 2-5 hours post drug administration
Working memory performance
Mean accuracy and reaction time on 1-back, 2-back and 3-back conditions compared with 0-back condition on the N-back task
Measured: Day 1: 2-5 hours post drug administration
Contextual learning
Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task
Measured: Day 1: 2-5 hours post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start7 Feb 2017
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular Mechanisms of Pharmacological ActionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, drsusannahmurphy, University of Oxford
- Investigators
- Susannah E Murphy, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863366
- Sponsor's protocol ID
- Acute_pruc
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Dose of Prucalopride on Emotional Processing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03863366
- Acronym / sponsor ID
- Acute_pruc
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mood Disorders, Mental Disorder, Antidepressive Agents
- Keywords
- 5-HT4, Prucalopride, Resolor, Emotional Processing, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prucalopride | Experimental | Drug: Prucalopride1mg prucalopride capsule |
| Placebo | Placebo comparator | Other: PlaceboLactose placebo capsule |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucaloprideAlso: Resolor1mg prucalopride tablet, encapsulated in white capsule | Drug | Prucalopride |
| PlaceboLactose placebo tablet, encapsulated in white capsule | Other | Placebo |
Primary outcome
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
7 secondary outcomes
Recall of emotional words
Time frame: Day 1: 2-5 hours post drug administration
Recognition of emotional words
Time frame: Day 1: 2-5 hours post drug administration
Attentional vigilance to emotional faces
Time frame: Day 1: 2-5 hours post drug administration
Recall of words Auditory Verbal Learning Task (AVLT)
Time frame: Day 1: 2-5 hours post drug administration
Reward and loss sensitivity
Time frame: Day 1: 2-5 hours post drug administration
Working memory performance
Time frame: Day 1: 2-5 hours post drug administration
Contextual learning
Time frame: Day 1: 2-5 hours post drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Psychopharmacology and Emotion Research LaboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susannah E Murphy, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prucalopride in people with Molecular Mechanisms of Pharmacological Action and Depression, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition of positive and negative facial expressions (time frame: Day 1: 2-5 hours post drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.