Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 1:06 PM
Study NCT ID:
NCT04585360
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychiatric Manifestations Associated With Behcet's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SCL90-R questionnaire', 'timeFrame': 'Inclusion visit', 'description': 'Anxiety/depression symptoms questionnaire'}], 'secondaryOutcomes': [{'measure': 'MINI questionnaire', 'timeFrame': 'Inclusion visit', 'description': 'Anxiety/depression symptoms questionnaire'}, {'measure': 'MFI questionnaire', 'timeFrame': 'Inclusion visit', 'description': 'Tiredness assessment'}, {'measure': 'SF36 questionnaire', 'timeFrame': 'Inclusion visit', 'description': 'Quality of life'}, {'measure': 'BSAS/BDCAF evaluation', 'timeFrame': 'Inclusion visit', 'description': "Behçet's disease activity"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Behçet's Disease, neuroBehcet, Anxiety, Depression, Tiredness"]}, 'descriptionModule': {'briefSummary': "The psychoBehçet'study is aimed at evaluating the psychological and neurocognitive symptoms in 25 consecutive patients followed for Behçet's disease. This is a monocentric, observational, non interventional study.", 'detailedDescription': "Patients will be evaluated during a day-care facility for Behçet's disease activity together with evaluation of anxiety and depression symptoms (SCL90-R and MINI assessments), fatigue (MFI) and quality of life (SF36)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient regularly monitored in the internal medicine department of Bicêtre', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male or female\n* Regular follow-up in the internal medicine department of Bicetre hospital\n* Diagnosed with Behçet's disease\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Poor command of the French language\n* Patients under legal protection\n* Pregnant woman"}, 'identificationModule': {'nctId': 'NCT04585360', 'acronym': 'PSYCHO-B7', 'briefTitle': "Psychiatric Manifestations Associated With Behcet's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "Psychiatric Manifestations Associated With Behcet's Disease", 'orgStudyIdInfo': {'id': '2019-A01819-48'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with Behcet disease', 'description': "adult patient with Behcet's disease followed regularly in the internal medicine department of Bicetre", 'interventionNames': ['Other: Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life']}], 'interventions': [{'name': 'Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life', 'type': 'OTHER', 'description': 'Realization of specific questionnaires evaluating:\n\n* psychiatric symptoms (self-assessment according to the SLC-90R questionnaire and hetero-assessment by the internist doctor of the center according to the M.I.N.I. questionnaire)\n* fatigue (Multidimensional Fatigue Inventory (MFI-20), French version, in self-assessment)\n* quality of life (SF36 self-assessment questionnaire)', 'armGroupLabels': ['Patient with Behcet disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'state': 'Val De Marne', 'country': 'France', 'contacts': [{'name': 'Nicolas NOEL, MD, PhD', 'role': 'CONTACT', 'email': 'nicolas.noel@aphp.fr', 'phone': '+ 331 45 21 27 57'}, {'name': 'Fanny URBAIN, MD', 'role': 'CONTACT', 'email': 'fanny.urbain@aphp.fr', 'phone': '+ 33 1 45 21 27 57'}], 'facility': 'Internal medecine department', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'centralContacts': [{'name': 'Nicolas NN NOEL, MD PhD', 'role': 'CONTACT', 'email': 'nicolas.noel@aphp.fr', 'phone': '+ 33 1 45 21 27 57'}, {'name': 'Fanny FU URBAIN, MD', 'role': 'CONTACT', 'email': 'fanny.urbain@aphp.fr', 'phone': '+ 33 1 45 21 27 57'}], 'overallOfficials': [{'name': 'NOEL NN Nicolas, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP, Hôpital Bicetre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}