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NOT YET RECRUITING
NCT07188506
NA

Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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. YOU-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. The specific objectives of the project are as follows: 1. To identify youth suicide risk factors through the integration of clinical, environmental, neuroimaging, genetic, and microbiome data; 2. To longitudinally evaluate the effectiveness of dTMS in the treatment of young people at risk of suicide; 3. To develop a predictive model based on machine learning techniques, grounded in multimodal data, to estimate the individual response to dTMS in this population. The 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.

Official title: Youth Suicide Risk Factors: Clinical, Neuroimaging, Genetic, and Microbiome Insights, and Predictors of Response to Deep Transcranial Magnetic Stimulation (dTMS)

Key Details

Gender

All

Age Range

18 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-10-31

Completion Date

2028-10-31

Last Updated

2025-09-29

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Clinical and blood parameters

Clinical data and MRI measurements

GENETIC

Illumina Infinium Global Screening Array 4.0 (GSA 4.0)

Genomic analyses

DEVICE

dTMS treatment

high-intensity deep transcranial magnetic stimulation (dTMS) device recognized for clinical application in mood disorders

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenza

Roma, RM, Italy