Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 11:16 PM
Study NCT ID:
NCT04504994
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress & Social Cognition in Borderline Personality Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'punishment behavior: number of accepted offers from co-player', 'timeFrame': '15 minutes after cyberball', 'description': 'Computer game'}], 'primaryOutcomes': [{'measure': 'empathy', 'timeFrame': '30 minutes after cyberball', 'description': 'Multifaceted Empathy Test'}], 'secondaryOutcomes': [{'measure': 'sharing behavior: amount of monetary units (max 30) shared with co-player', 'timeFrame': 'directly after cyberball', 'description': 'Computer game'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Borderline Personality Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.', 'detailedDescription': 'The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior, such as empathy, in BPD patients and whether this "fight-or-flight" pattern is also seen in other relevant aspects of social behavior, such as sharing and punishment behavior. To induce social exclusion all participants will play cyberball, either the exclusion condition or the (over)inclusion condition before testing'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female only', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfemale patients with BPD and healthy control women, matched for age, body mass index, and education\n\nExclusion Criteria:\n\nphysical illness'}, 'identificationModule': {'nctId': 'NCT04504994', 'acronym': 'SOKO-1', 'briefTitle': 'Stress & Social Cognition in Borderline Personality Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': '"Fight-or-flight" Versus "Tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I', 'orgStudyIdInfo': {'id': 'WI 3396/12-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exclusion BPD', 'description': 'cyberball exclusion condition - BPD patients', 'interventionNames': ['Behavioral: inclusion condition']}, {'type': 'EXPERIMENTAL', 'label': 'over-inclusion BPD', 'description': 'cyberball over-inclusion condition - BPD patients', 'interventionNames': ['Behavioral: inclusion condition']}, {'type': 'EXPERIMENTAL', 'label': 'exclusion healthy controls', 'description': 'cyberball exclusion condition - healthy controls', 'interventionNames': ['Behavioral: inclusion condition']}, {'type': 'EXPERIMENTAL', 'label': 'over-inclusion healthy controls', 'description': 'cyberball over-inclusion condition - healthy controls', 'interventionNames': ['Behavioral: inclusion condition']}], 'interventions': [{'name': 'inclusion condition', 'type': 'BEHAVIORAL', 'description': 'cyberball game: ex- versus over-inclusion condition', 'armGroupLabels': ['exclusion BPD', 'exclusion healthy controls', 'over-inclusion BPD', 'over-inclusion healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katja Wingenfeld', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}