Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 7:08 AM
Study NCT ID:
NCT05843604
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2023-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral and Cognitive Markers of Treatment Resistance in Obsessive Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral activity modification during N-back task', 'timeFrame': 'Day 1', 'description': 'Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls'}, {'measure': 'Cerebral activity modification during Stroop task', 'timeFrame': 'Day 1', 'description': 'Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls'}, {'measure': 'Cerebral activity modification during switching task (Monsell et Mizon task )', 'timeFrame': 'Day 1', 'description': 'Blood-oxygen-level-dependent (BOLD) modification during the task between obsessive compulsive disorder patients and controls'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['functional MRI'], 'conditions': ['OCD']}, 'descriptionModule': {'briefSummary': 'This study aims to define individual profiles of treatment resistants in order to find indicators and predictors of the therapeutic response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from the Clinical Research Unit of Poitiers. All volunteer patients included in this study will be included regardless of the degree of resistance to treatment or the severity of their disease. Patients will not be hospitalized for the duration of the study unless their condition requires it.\n\nHealthy volunteers will be recruited locally by advertisement or through acquaintances, and will be matched to each patient based on age, gender, laterality, and education level. They must not have an acute pathology being treated, nor take psychotropic drugs, nor be followed in psychotherapy. In their history, we must not find hospitalization in a psychiatric environment or a psychiatric illness according to the M.I.N.I. version 5.0.0.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obsessive compulsive disorder diagnosed according to Diagnostic and Statistical Manual 5 criteria (patients will be included regardless of the severity and resistance of their pathology and their levels of executive functions)\n* Understand and accept the constraints of the study\n* Be a beneficiary or affiliated to a Health Insurance scheme\n\nExclusion Criteria:\n\n* Present one of the diagnoses according to the criteria of the DSM 5: schizophrenic disorders, substance abuse or dependence to a substance according to the criteria of the M.I.N.I. version 5.0 (Sheehan et al., 1998)\n* Generalized anxiety disorder, social anxiety, nicotine dependence and history of a major depressive episode are not exclusion criteria according to the M.I.N.I. version 5.0 (Sheehan et al., 1998)\n* Have a serious intercurrent pathology\n* Being a pregnant woman\n* Being a woman of childbearing age without effective contraception.\n* Being hospitalized under duress or on an outpatient basis in a care program\n* Being under judicial protection (reinforced curatorship, guardianship)'}, 'identificationModule': {'nctId': 'NCT05843604', 'acronym': '3TOC', 'briefTitle': 'Cerebral and Cognitive Markers of Treatment Resistance in Obsessive Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Henri Laborit'}, 'officialTitle': 'Cerebral and Cognitive Markers of Treatment Resistance in Obsessive-compulsive Disorder: Towards Personalization of Patient Care', 'orgStudyIdInfo': {'id': '2022-A00463-40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'obsessive compulsive disorder patients', 'interventionNames': ['Other: Functional MRI']}, {'label': 'Control Patients', 'interventionNames': ['Other: Functional MRI']}], 'interventions': [{'name': 'Functional MRI', 'type': 'OTHER', 'description': 'Three cognitive tests will be performed in the MRI, namely a stroop task, an N-back task and a switching task', 'armGroupLabels': ['Control Patients', 'obsessive compulsive disorder patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien Doolub, MD', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Henri Laborit', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'Damien Doolub, MD', 'role': 'CONTACT', 'email': 'damien.doolub@ch-poitiers.fr', 'phone': '+33 (0)5 16 61 18'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Henri Laborit', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}