Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT01216605
Status:
COMPLETED
Last Update Posted:
2010-10-07
First Post:
2010-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxytocin and Emotion Recognition
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-06', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance on a facial emotion recognition task', 'timeFrame': '45 min. following drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Health']}, 'descriptionModule': {'briefSummary': 'The present study was designed to investigate the effects of a single dose of synthetic oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary the level of awareness. In a randomized placebo-controlled between-subject design, recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition. We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed with limited awareness.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males\n* 18 to 40 years of age\n\nExclusion Criteria:\n\n* Any psychiatric diagnosis life-time\n* Somatic disease\n* IQ \\< 85\n* Smoker\n* Psychoactive medication'}, 'identificationModule': {'nctId': 'NCT01216605', 'briefTitle': 'Oxytocin and Emotion Recognition', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'orgStudyIdInfo': {'id': 'X01A-DO1312/1-1'}, 'secondaryIdInfos': [{'id': 'DO1312/1-1', 'type': 'OTHER_GRANT', 'domain': 'German Research Foundation (DFG)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin', 'interventionNames': ['Drug: Syntocinon 24 IU']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Syntocinon 24 IU', 'type': 'DRUG', 'armGroupLabels': ['Oxytocin']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18055', 'city': 'Rostock', 'state': 'D', 'country': 'Germany', 'facility': 'Department of PSychiatry University of Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Gregor Domes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}}}}