Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-02-25 @ 6:55 PM
Study NCT ID:
NCT06098469
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2023-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission', 'timeFrame': 'Week 10', 'description': 'Reduction in MADRS score to \\< 8 (complete remission) after 10 neurofeedback sessions, in particular cumulative score less than or equal to 2 for hedonic and fatigue dimensions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 25 to 65 included\n* Information and signed informed consent\n* Patients with a diagnosis of major depressive episode in remission\n* MADRS score between 14 and 22\n* Patients with residual symptoms as assessed by MADRS items\n* No cognitive impairment.\n* Right-handed\n\nExclusion Criteria:\n\n* Subjects with legal incapacity or limited legal capacity\n* Subjects unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator\n* Pregnant women\n* Subjects in the exclusion period of another study or is on the "national volunteer list".\n* Subjects with another psychiatric pathology (bipolar mood disorder, psychosis, obsessive-compulsive disorder, addictive pathology, schizophrenia)\n* Subjects under a protective measure such as guardianship or safeguard of justice.'}, 'identificationModule': {'nctId': 'NCT06098469', 'acronym': 'DEEPBLUE', 'briefTitle': 'Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression', 'orgStudyIdInfo': {'id': 'API/2019/102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback', 'description': '10 neurofeedback sessions + depressive rating scales', 'interventionNames': ['Device: Neurofeedback sessions']}], 'interventions': [{'name': 'Neurofeedback sessions', 'type': 'DEVICE', 'description': '10 Neurofeedback sessions, psychiatric interview (MADRS, QIDS-C16), reverse-correlation task, QIDS-SR16, EQ-5D-5L, motivation assessment', 'armGroupLabels': ['Neurofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine Charrière, PhD', 'role': 'CONTACT', 'email': 'kcharriere@chu-besancon.fr', 'phone': '+33381218999'}, {'name': 'Magali Nicolier', 'role': 'CONTACT', 'email': 'mnicolier@chu-besancon.fr'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Karine CHARRIERE, PhD', 'role': 'CONTACT', 'email': 'kcharriere@chu-besancon.fr', 'phone': '+333 81218999'}], 'overallOfficials': [{'name': 'Emmanuel HAFFEN, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Besançon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}