Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-08 @ 1:46 AM
Study NCT ID:
NCT02478034
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mineralocorticoid Receptor Stimulation on Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005438', 'term': 'Fludrocortisone'}, {'id': 'C034635', 'term': 'fludrocortisone acetate'}], 'ancestors': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-04', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-18', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'social cognition', 'timeFrame': '25 min', 'description': 'computer based tests: emotion recognition'}], 'secondaryOutcomes': [{'measure': 'memory', 'timeFrame': '20 min', 'description': 'computer based test on visuospacial memory'}, {'measure': 'decision making', 'timeFrame': '25 min', 'description': 'computer based tests: BART'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Individuality']}, 'descriptionModule': {'briefSummary': 'In this study the effects of mineralocorticoid stimulation on social cognition will be investigated in healthy young individuals.', 'detailedDescription': '80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 0.4 mg Fludrocortison before testing. Tasks will on emotion recognition, Task Switch, visual spacial memory and decision making will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* free of medication\n* age 18 - 30\n\nExclusion Criteria:\n\n* any medication\n* severe illness'}, 'identificationModule': {'nctId': 'NCT02478034', 'acronym': 'MR-STIM', 'briefTitle': 'Effects of Mineralocorticoid Receptor Stimulation on Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effekte Von Fludrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten', 'orgStudyIdInfo': {'id': 'WI-CO-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fludrocortisone', 'description': 'effects of fludrocortisone on cognition compared to placebo', 'interventionNames': ['Other: Fludrocortisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'effects of fludrocortisone on cognition compared to placebo', 'interventionNames': ['Other: Fludrocortisone']}], 'interventions': [{'name': 'Fludrocortisone', 'type': 'OTHER', 'otherNames': ['Florinef (Squibb & Sons Limited)'], 'description': 'effects of fludrocortisone on cognition compared to placebo', 'armGroupLabels': ['Placebo', 'fludrocortisone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Katja Wingenfeld, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr., Head: Clinical Psychology', 'investigatorFullName': 'Katja Wingenfeld', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}