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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07188506
Status
Not Yet Recruiting

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Conditions

  • Mood Disorders
  • Suicidal Ideation
  • Suicide Prevention
  • Suicide, Attempted

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Clinical and blood parameters — DIAGNOSTIC_TEST
    Clinical data and MRI measurements
  • Illumina Infinium Global Screening Array 4.0 (GSA 4.0) — GENETIC
    Genomic analyses
  • dTMS treatment — DEVICE
    high-intensity deep transcranial magnetic stimulation (dTMS) device recognized for clinical application in mood disorders

Study Details

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.

Key Dates

First listed
Sep 23, 2025
Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Suicidal clinic group
    60 patients at suicidal risk
  • Experimental: Not-Suicidal clinic group
    60 patients without suicidal risk
  • Active Comparator: Healthy Controls
    60 healthy controls (HCs)

Primary Outcome Measure

Change of suicidal risk [ Time Frame: 3 months ]

Central Contacts

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