Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 3:33 PM
Study NCT ID:
NCT03863366
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2019-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Acute Prucalopride Administration in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-01', 'studyFirstSubmitDate': '2019-02-26', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recognition of positive and negative facial expressions', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': 'Accuracy to identify positive vs. negative facial expressions of emotion on the FERT'}], 'secondaryOutcomes': [{'measure': 'Recall of emotional words', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': 'Number of positive and negative words correctly (and incorrectly) recalled in the EREC task'}, {'measure': 'Recognition of emotional words', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': 'Number of positive and negative words correctly (and incorrectly) recognised in the EMEM task'}, {'measure': 'Attentional vigilance to emotional faces', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': 'Attentional vigilance to fearful and happy faces in the FDOT task'}, {'measure': 'Recall of words Auditory Verbal Learning Task (AVLT)', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': 'Number of items correctly and incorrectly recalled across blocks'}, {'measure': 'Reward and loss sensitivity', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': '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'}, {'measure': 'Working memory performance', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': 'Mean accuracy and reaction time on 1-back, 2-back and 3-back conditions compared with 0-back condition on the N-back task'}, {'measure': 'Contextual learning', 'timeFrame': 'Day 1: 2-5 hours post drug administration', 'description': 'Difference between reaction time and accuracy on novel and repeated arrays in the contextual cueing task'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['5-HT4', 'Prucalopride', 'Resolor', 'Emotional Processing', 'Healthy Volunteers'], 'conditions': ['Molecular Mechanisms of Pharmacological Action', 'Depression', 'Depressive Disorder', 'Mood Disorders', 'Mental Disorder', 'Antidepressive Agents', 'Cognition']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.perloxford.org', 'label': 'Psychopharmacology and Emotion Research Laboratory'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Aged 18-40 years\n* Willing and able to give informed consent for participation in the study\n* Sufficiently fluent English to understand and complete the task\n\nExclusion Criteria:\n\n* Current usage of psychoactive medication (except the contraceptive pill, the Depo-Provera injection or the progesterone implant)\n* Any past or current Axis 1 DSM-IV psychiatric disorder\n* Significant medical condition\n* Current or past gastro-intestinal disorder or irritable bowel syndrome\n* Current pregnancy or breastfeeding\n* Known lactate deficiency or any other problem absorbing lactose, galactose or glucose\n* Current or past history of drug or alcohol dependency\n* Participation in a psychological or medical study involving the use of medication within the last 3 months\n* Previous participation in a study using the same, or similar, emotional processing tasks\n* Smoker \\> 5 cigarettes per day\n* Typically drinks \\> 6 caffeinated drinks per day'}, 'identificationModule': {'nctId': 'NCT03863366', 'briefTitle': 'Effects of Acute Prucalopride Administration in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'The Effect of a Single Dose of Prucalopride on Emotional Processing in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Acute_pruc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prucalopride', 'description': '1mg prucalopride capsule', 'interventionNames': ['Drug: Prucalopride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Lactose placebo capsule', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Prucalopride', 'type': 'DRUG', 'otherNames': ['Resolor'], 'description': '1mg prucalopride tablet, encapsulated in white capsule', 'armGroupLabels': ['Prucalopride']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Lactose placebo tablet, encapsulated in white capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7JX', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'University of Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Susannah E Murphy, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'drsusannahmurphy', 'investigatorAffiliation': 'University of Oxford'}}}}