Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-10 @ 8:21 PM
Study NCT ID:
NCT03122067
Status:
UNKNOWN
Last Update Posted:
2018-02-07
First Post:
2017-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin's Effect on Social Pain Empathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neural activity changes associated with oxytocin administration', 'timeFrame': '45-60 minutes after drug administration', 'description': 'fMRI-assessed brain activity during observing other being socially excluded'}], 'secondaryOutcomes': [{'measure': 'Behavioral changes associated with oxytocin administration: ball-tossing', 'timeFrame': '45-60 minutes after drug administration', 'description': 'Number of tosses to the other players (the excluder, new player, or previously excluded player)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxytocin', 'social cognition', 'fMRI', 'empathy'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The aim of the present experiment is to examine oxytocin's behavioral and neural effects on social pain empathy", 'detailedDescription': 'In the current study, the investigators plan to examine whether oxytocin modulates behavior and neural activity during observing another person being excluded in an online ball-tossing game (a modified cyberball paradigm).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy participants without past or current psychiatric or neurological disorders\n\nExclusion Criteria:\n\n* history of head injury\n* medical or psychiatric illness\n* smoking or drinking 24 hours before experiment'}, 'identificationModule': {'nctId': 'NCT03122067', 'briefTitle': "Oxytocin's Effect on Social Pain Empathy", 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'Oxytocinergic Modulation of Perceived Social Exclusion', 'orgStudyIdInfo': {'id': 'UESTC-neuSCAN-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxytocin group', 'description': 'male participants with oxytocin treatment', 'interventionNames': ['Drug: oxytocin treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'male participants with placebo treatment', 'interventionNames': ['Drug: placebo treatment']}], 'interventions': [{'name': 'oxytocin treatment', 'type': 'DRUG', 'description': 'intranasal administration of oxytocin', 'armGroupLabels': ['oxytocin group']}, {'name': 'placebo treatment', 'type': 'DRUG', 'description': 'intranasal administration of placebo', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Benjamin Becker, Dr.', 'role': 'CONTACT', 'email': 'ben_becker@gmx.de'}], 'facility': 'School of Life Science and Technology, University of Electronic Science and Technology of China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Keith Kendrick, Dr.', 'role': 'CONTACT', 'email': 'k.kendrick.uestc@gmail.com'}], 'overallOfficials': [{'name': 'Keith Kendrick, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Life Science and Technology, University of Electronic Science and Technology of China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Electronic Science and Technology of China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keith Kendrick', 'investigatorAffiliation': 'University of Electronic Science and Technology of China'}}}}