Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-14 @ 1:55 AM
Study NCT ID:
NCT03128203
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2017-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intranasal Oxytocin on Striatal Functional Connectivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Striatal functional connectivity alterations after drug administration', 'timeFrame': '45 minutes after drug administration', 'description': 'fMRI-based resting state connectivity of the striatum will be compared between the oxytocin and the placebo group'}]}, 'conditionsModule': {'keywords': ['Oxytocin', 'Resting-state', 'Functional connectivity', 'BOLD'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate whether 40 IU of intranasal oxytocin treatment can influence the resting-state functional connectivity in healthy males.', 'detailedDescription': 'In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effects of oxytocin treatment on resting-state functional connectivity.\n\nSubject will receive either intranasal oxytocin or placebo administration and go through a seven-minute resting-state scan in MRI scanner to test whether oxytocin changes functional connectivity in the brain. Trait anxiety and mood questionnaires will be administered as control variables.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects without past or current psychiatric or neurological disorders\n\nExclusion Criteria:\n\n* with MRI Contraindications'}, 'identificationModule': {'nctId': 'NCT03128203', 'briefTitle': 'Effects of Intranasal Oxytocin on Striatal Functional Connectivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'Effects of Intranasal Oxytocin on Striatal Functional Connectivity in Healthy Males', 'orgStudyIdInfo': {'id': 'UESTC-neuSCAN-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Oxytocin, intranasally administrated', 'armGroupLabels': ['Oxytocin']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Saline, intranasally administrated', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'School of Life Science and Technology, University of Electronic Science and Technology of China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Benjamin Becker, 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': 'Benjamin Becker', 'investigatorAffiliation': 'University of Electronic Science and Technology of China'}}}}