Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-01 @ 2:11 AM
Study NCT ID:
NCT07188506
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D000092864', 'term': 'Suicide Prevention'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of suicidal risk', 'timeFrame': '3 months', 'description': 'Reduction of suicidal risk, assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) score (No, Low, Moderate, High)'}], 'secondaryOutcomes': [{'measure': 'Severity of depressive symptoms', 'timeFrame': '3 months', 'description': 'Severity of depressive symptoms, assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS):\n\n0 to 6: normal/symptom absent 7 to 19: mild depression 20 to 34: moderate depression 35 to 60: severe depression'}, {'measure': 'General psychiatric symptoms', 'timeFrame': '3 months', 'description': 'General psychiatric symptoms measured with the Brief Psychiatric Rating Scale (BPRS).\n\nThe rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mood Disorders', 'Suicide, Attempted', 'Suicidal Ideation', 'Suicide Prevention']}, 'descriptionModule': {'briefSummary': 'The YOU-SURF project is at the forefront of youth suicide prevention, with the goal of integrating multimodal clinical and neurobiological data to comprehensively identify risk factors and the most effective intervention strategies. Suicide is one of the leading causes of death among young people, with particularly alarming incidence rates during adolescence and early adulthood. Suicidal risk is a complex phenomenon, determined by a multiplicity of clinical, environmental, and biological factors. Emerging evidence suggests that information derived from neuroimaging, genetics, and the microbiome may also play a significant role. However, studies conducted to date have not yet adopted a truly multimodal approach that jointly integrates these dimensions in the identification of risk factors for suicide in youth. The YOU-SURF project aims to fill this critical gap.\n\nYOU-SURF will also pioneer the use of deep transcranial magnetic stimulation (dTMS), an innovative neuromodulation technique, whose effectiveness in reducing suicidal risk in young people will be assessed within a longitudinal design. Although some preliminary evidence suggests a potential benefit of neuromodulation treatments in this population, the specific effects of dTMS on suicidal risk in youth remain largely unexplored. Furthermore, there is a significant lack of knowledge regarding predictors of response to dTMS in young individuals at risk for self-harming behaviors.\n\nThe specific objectives of the project are as follows:\n\n1. To identify youth suicide risk factors through the integration of clinical, environmental, neuroimaging, genetic, and microbiome data;\n2. To longitudinally evaluate the effectiveness of dTMS in the treatment of young people at risk of suicide;\n3. To develop a predictive model based on machine learning techniques, grounded in multimodal data, to estimate the individual response to dTMS in this population.\n\nThe results of the project will provide a solid scientific basis for the development of personalized prevention and treatment interventions, improving clinical effectiveness and resource allocation in youth mental health services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of mood disorder (major depressive episode, major depressive disorder, or bipolar disorder) according to DSM-5;\n* Age between 18 and 25 years;\n* Eligibility for magnetic resonance imaging;\n* Proficiency in the Italian language.\n\nExclusion Criteria:\n\n* Comorbidity with severe neurological or medical conditions;\n* Diagnosis of cognitive impairment;\n* Inability to provide informed consent.\n\nFor the control group:\n\nInclusion Criteria:\n\nthe same as the experimental group.\n\nExclusion Criteria:\n\n* subjects with DSM-5 disorders\n* subjects with a family history of psychiatric disorders will be excluded.'}, 'identificationModule': {'nctId': 'NCT07188506', 'acronym': 'YOU-SURF', 'briefTitle': 'Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Youth Suicide Risk Factors: Clinical, Neuroimaging, Genetic, and Microbiome Insights, and Predictors of Response to Deep Transcranial Magnetic Stimulation (dTMS)', 'orgStudyIdInfo': {'id': '8012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suicidal clinic group', 'description': '60 patients at suicidal risk', 'interventionNames': ['Diagnostic Test: Clinical and blood parameters', 'Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)', 'Device: dTMS treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Not-Suicidal clinic group', 'description': '60 patients without suicidal risk', 'interventionNames': ['Diagnostic Test: Clinical and blood parameters', 'Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)', 'Device: dTMS treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Controls', 'description': '60 healthy controls (HCs)', 'interventionNames': ['Diagnostic Test: Clinical and blood parameters', 'Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)']}], 'interventions': [{'name': 'Clinical and blood parameters', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Magnetic Resonance Imaging (MRI) protocol'], 'description': 'Clinical data and MRI measurements', 'armGroupLabels': ['Healthy Controls', 'Not-Suicidal clinic group', 'Suicidal clinic group']}, {'name': 'Illumina Infinium Global Screening Array 4.0 (GSA 4.0)', 'type': 'GENETIC', 'otherNames': ['Microbiota protocol'], 'description': 'Genomic analyses', 'armGroupLabels': ['Healthy Controls', 'Not-Suicidal clinic group', 'Suicidal clinic group']}, {'name': 'dTMS treatment', 'type': 'DEVICE', 'description': 'high-intensity deep transcranial magnetic stimulation (dTMS) device recognized for clinical application in mood disorders', 'armGroupLabels': ['Not-Suicidal clinic group', 'Suicidal clinic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'contacts': [{'name': 'Delfina Janiri', 'role': 'CONTACT', 'email': 'delfina.janiri@unicatt.it', 'phone': '+390630159527'}, {'name': 'Mario Pinto', 'role': 'CONTACT', 'email': 'mario.pinto@guest.policlinicogemelli.it'}, {'name': 'Delfina Janiri', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gabriele Sani', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Silvia Montanari', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenza", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Delfina Janiri', 'role': 'CONTACT', 'email': 'delfina.janiri@unicatt.it', 'phone': '+390630159527'}], 'overallOfficials': [{'name': 'Delfina Janiri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}