Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-31 @ 11:08 AM
Study NCT ID:
NCT02156661
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2014-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin and Emotion Processing
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain activity', 'timeFrame': 'During emotion processing', 'description': 'fMRI'}], 'secondaryOutcomes': [{'measure': 'Psychophysiological response', 'timeFrame': 'During stimuli presentation', 'description': 'Skin conductance response'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Males']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oxytocin influences emotional processing and learning of emotional and social stimuli.', 'detailedDescription': 'An effect of OXT on emotion processing and anxiety has been broadly investigated in animal studies. However, in humans, effects seem more complex.\n\nThe rationale of the study is to examine direct effects of OXT to processing and learning of emotional and social values in humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers\n\nExclusion Criteria:\n\n* Current or past psychiatric disease\n* Current or past physical illness\n* Psychoactive medication\n* Tobacco smokers\n* MRI contraindication'}, 'identificationModule': {'nctId': 'NCT02156661', 'briefTitle': 'Oxytocin and Emotion Processing', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'orgStudyIdInfo': {'id': 'OXT-FC-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin', 'description': 'Oxytocin: Syntocinon-Spray, Novartis\n\nintranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo nasal spray', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'armGroupLabels': ['Oxytocin', 'Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rene Hurlemann', 'investigatorAffiliation': 'University Hospital, Bonn'}}}}