Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:42 AM
Study NCT ID:
NCT06036160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-06
First Post:
2023-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Integrated Care of Depression in Primary Care Pathways
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019033', 'term': 'Delivery of Health Care, Integrated'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-03', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients completing the study per-protocol', 'timeFrame': '3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65 years\n* Good understanding of french language\n* Major depressive disorder based on DSM-V criteria\n* MADRS \\> 19\n* FAilure of two antidepressants during 6wks at standard minimal dose\n\nExclusion Criteria:\n\n* Pregnancy or lactating\n* People under tutelage\n* bipolar disorder\n* no health insurance\n* neurological disorders\n* contra-indication to physical activity\n* high suicidal risk\n* first degree history of bipolar disorder, schizophrenia, autism spectrum disorder'}, 'identificationModule': {'nctId': 'NCT06036160', 'acronym': 'ESPRI-PSY', 'briefTitle': 'Feasibility of Integrated Care of Depression in Primary Care Pathways', 'organization': {'class': 'OTHER', 'fullName': 'Association De La Msp Pasteur'}, 'officialTitle': 'Evaluation de Soins Primaires Intégrés en Psychiatrie', 'orgStudyIdInfo': {'id': '202201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated care', 'interventionNames': ['Other: Integrated care']}], 'interventions': [{'name': 'Integrated care', 'type': 'OTHER', 'description': 'Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation', 'armGroupLabels': ['Integrated care']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association De La Msp Pasteur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}