Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 11:05 AM
Study NCT ID:
NCT04815395
Status:
COMPLETED
Last Update Posted:
2021-03-25
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differential Effects of Oral and Intranasal Oxytocin on Attention Control
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differential effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli', 'timeFrame': '45 minutes - 100 minutes after treatment', 'description': 'Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the intranasal and oral oxytocin and placebo treatment conditions'}, {'measure': 'Differential effects of intranasal and oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli', 'timeFrame': '45 minutes - 100 minutes after treatment', 'description': 'Comparison between social-specific error rates of saccade/antisaccade between the intranasal and oral oxytocin and placebo treatment conditions.'}], 'secondaryOutcomes': [{'measure': 'Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions', 'timeFrame': '45 minutes - 100 minutes after treatment', 'description': 'Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the intranasal and oral oxytocin and placebo treatment conditions'}, {'measure': 'Emotion-specific effects of intranasal and oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions', 'timeFrame': '45 minutes - 100 minutes after treatment', 'description': 'Comparison between emotion-specific saccade/antisaccade error rates between the intranasal and oral oxytocin and placebo treatment conditions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antisaccade task', 'Attention control', 'Oxytocin', 'Eye-tracking'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main aim of the present study is to investigate whether oxytocin (24IU) via different routes have divergent effects on attention control in a social-emotional saccade/antisaccade eye-tracking paradigm.', 'detailedDescription': "Previous studies have demonstrated oral and intranasal oxytocin's divergent effects on arousal rating and neural responses to emotional faces, however, it remains unclear whether different routes of oxytocin treatment would have differential effects on attention processing to social stimuli. Based on the previous registered studies (ClinicalTrials.gov ID: NCT04493515 and NCT03486925) from our group using a validated emotional anti-saccade task with social stimuli (emotional faces) and non-social stimuli (oval shape) have separately explored oral and intranasal oxytocin's modulatory effects on attention processing, the present study aims to conduct a secondary analysis of the previously acquired data to directly compare oxytocin's effects on attention control to social emotional stimuli via different routes. To this end data from subjects who underwent intranasal oxytocin administration (n = 33, NCT03486925) will be compared with data from subjects who underwent oral oxytocin or placebo administration (n = 36, or 37 respectively; NCT04493515). To further control for non-treatment related factors the intranasal placebo and oral placebo groups from the previous studies (ClinicalTrials.gov ID: NCT03486925 and NCT04493515) will be compared with respect to primary and secondary outcome measures of the trial, in particular general and emotion-specific effects on attentional control."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, healthy participants\n* Non smokers\n\nExclusion Criteria:\n\n* Previous or current medical, psychiatric, neurological disorder\n* Regular medication\n* Use of any psychoactive substances in the 24 hours before experiment\n* Contra-indications for eye-tracking data acquisition'}, 'identificationModule': {'nctId': 'NCT04815395', 'briefTitle': 'Differential Effects of Oral and Intranasal Oxytocin on Attention Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'The Differential Effects of Oral and Intranasal Oxytocin on Attention Control', 'orgStudyIdInfo': {'id': 'UESTC-neuSCAN-80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Oxytocin', 'description': 'Oxytocin (24IU) orally', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal Oxytocin', 'description': 'Oxytocin (24IU) intranasally', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo', 'description': 'Placebo orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Administration of oxytocin (24IU) orally', 'armGroupLabels': ['Oral Oxytocin']}, {'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Administration of oxytocin (24IU) intranasally', 'armGroupLabels': ['Intranasal Oxytocin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administration of placebo orally', 'armGroupLabels': ['Oral Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'University of Electronic Science and Technology of China(UESTC)', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Keith Kendrick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Electronic Science and Technology of China (UESTC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}}}}