Molecular Mechanisms of Pharmacological ActionNCT03572790
Effects of Seven Day 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 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. 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
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2018to 17 May 2019
- 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
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Seven Day Prucalopride Administration on Emotional Processing 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.
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mood Disorders, Mental Disorders, Antidepressive Agents
- Being tested
- Prucalopride, Placebo
- Keywords
- 5-HT4, Prucalopride, Resolor, Functional Magnetic Resonance Imaging (fMRI), 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 capsule, once daily for seven days
PlaceboOther
Lactose placebo capsule, once daily for seven days
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride | Experimental | Not described Receives: Drug: Prucalopride |
| Placebo | Placebo comparator | Not described 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 recognise positive and negative facial expressions (anger, disgust, fear, happy , sad, surprise)
Measured: Completed on Day 7
Performance on Auditory Verbal Learning Task (AVLT)
Accuracy on AVLT (number of items recalled across blocks)
Measured: Completed on Day 7
Secondary outcomes (8)
Neural response to emotional faces
Blood Oxygen Level Dependent (BOLD) signal in a network including the amygdala, anterior cingulate cortex, and orbitofrontal cortex
Measured: Completed on Day 6
Neural response to novel vs repeated scenes
BOLD signal to scenes that have previously been seen compared to novel scenes in a network including the hippocampus and parahippocampal regions
Measured: Completed on Day 6
Reward sensitivity
Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task (PILT)
Measured: Completed on Day 7
Categorisation, recall, and recognition of emotional words
Accuracy and reaction time to categorise positive and negative descriptor words; number of words correctly (hits) and incorrectly (false alarms) recalled and recognised
Measured: Completed on Day 7
Vigilance to fearful and happy faces on the Facial Dot Probe Task (FDOT)
Vigilance derived from reaction time
Measured: Completed on Day 7
Resting state connectivity
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
Measured: Completed on Day 6
Relative and global cerebral blood flow
Arterial spin labelling (ASL) global and cerebral blood flow
Measured: Completed on Day 6
Visual short term memory on the Oxford Memory Test (OMT)
Proportion of correct probe selections, absolute error for probe location, reaction time, and proportion of misbinding errors
Measured: Completed on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start11 Jun 2018
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT03572790
- Sponsor's protocol ID
- Pruc_7d
- Status last verified
- Nov 2022
- First submitted
- 7 Jun 2018
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37098409
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Seven Day Prucalopride Administration on Emotional Processing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03572790
- Acronym / sponsor ID
- Pruc_7d
- Conditions
- Molecular Mechanisms of Pharmacological Action, Depression, Depressive Disorder, Mood Disorders, Mental Disorders, Antidepressive Agents
- Keywords
- 5-HT4, Prucalopride, Resolor, Functional Magnetic Resonance Imaging (fMRI), Emotional Processing, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 28 Jun 2018 (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 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.
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 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.
| Arm | Type | Receives |
|---|---|---|
| Prucalopride | Experimental | Drug: Prucalopride |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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 capsule, once daily for seven days | Drug | Prucalopride |
| PlaceboLactose placebo capsule, once daily for seven days | Other | Placebo |
Primary outcome
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)
Performance on Auditory Verbal Learning Task (AVLT)
Time frame: Completed on Day 7
Accuracy on AVLT (number of items recalled across blocks)
8 secondary outcomes
Neural response to emotional faces
Time frame: Completed on Day 6
Neural response to novel vs repeated scenes
Time frame: Completed on Day 6
Reward sensitivity
Time frame: Completed on Day 7
Categorisation, recall, and recognition of emotional words
Time frame: Completed on Day 7
Vigilance to fearful and happy faces on the Facial Dot Probe Task (FDOT)
Time frame: Completed on Day 7
Resting state connectivity
Time frame: Completed on Day 6
Relative and global cerebral blood flow
Time frame: Completed on Day 6
Visual short term memory on the Oxford Memory Test (OMT)
Time frame: Completed on Day 7
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 18 Nov 2022.
- Derived from this study: PubMed 37098409de 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.
- 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 7 inclusion and 19 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 18 Nov 2022. 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: Completed on Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572790, which also lists 1 linked publication.
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 18 Nov 2022.