Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-04 @ 11:14 PM
Study NCT ID:
NCT02847533
Status:
UNKNOWN
Last Update Posted:
2016-07-28
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Markers and Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasmatic concentration of Interleukin 6', 'timeFrame': 'at patient inclusion'}], 'secondaryOutcomes': [{'measure': 'concentration of proinflammatory cytokine', 'timeFrame': 'at patient inclusion', 'description': 'Expression intensity of monocytes costimulation molecules'}, {'measure': 'concentration of antiinflammatory cytokine', 'timeFrame': 'at patient inclusion'}, {'measure': 'functional polymorphisms of expression genes of inflammatory proteins', 'timeFrame': 'at patient inclusion'}, {'measure': 'plasmatic concentration of Retinoid X receptor signaling pathway', 'timeFrame': 'at patient inclusion'}, {'measure': 'Expression rate of monocytes costimulation molecules', 'timeFrame': 'at patient inclusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['resistant depression', 'inflammation'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA,\n* group 2: patients with MDD remission after response to an antidepressant treatment.\n\nExclusion Criteria:\n\n* comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection'}, 'identificationModule': {'nctId': 'NCT02847533', 'acronym': 'InDep', 'briefTitle': 'Inflammatory Markers and Resistant Depression', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Inflammatory Markers and Resistant Depression', 'orgStudyIdInfo': {'id': 'API/2014/50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'resistant depression', 'description': 'patients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode)', 'interventionNames': ['Procedure: blood sample', 'Behavioral: psychometric scales']}, {'type': 'OTHER', 'label': 'non resistant depression', 'description': 'patients in remission from unipolar depressive disorder', 'interventionNames': ['Procedure: blood sample', 'Behavioral: psychometric scales']}], 'interventions': [{'name': 'blood sample', 'type': 'PROCEDURE', 'description': 'blood sample for concentration levels of inflammatory markers', 'armGroupLabels': ['non resistant depression', 'resistant depression']}, {'name': 'psychometric scales', 'type': 'BEHAVIORAL', 'description': 'Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD', 'armGroupLabels': ['non resistant depression', 'resistant depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'contacts': [{'name': 'Sophie Depierre', 'role': 'CONTACT', 'email': 'sdepierre@chu-besancon.fr', 'phone': '03841218745'}, {'name': 'Emmanuel Haffen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pierre Vandel, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Djamila Bennabi, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nazim Nekrouf, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julie Giustiniani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Masse-Sibille, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Emmanuel Haffen, MD PhD', 'role': 'CONTACT', 'email': 'ehaffen@chu-besancon.fr', 'phone': '0033381218388'}, {'name': 'Julie Monnin, PhD', 'role': 'CONTACT', 'email': 'jmonnin@chu-besancon.fr', 'phone': '0033381218543'}], 'overallOfficials': [{'name': 'Emmanuel Haffen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}