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Recruiting Not applicable

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

NCT07188506 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-11-15
Last updated
2026-08-28

Condition(s) studied

Mood DisordersSuicide, AttemptedSuicidal IdeationSuicide Prevention

Investigational drug(s) / intervention(s)

Clinical and blood parametersIllumina Infinium Global Screening Array 4.0 (GSA 4.0)dTMS treatment

Clinical and blood parameters: Clinical data and MRI measurements

Illumina Infinium Global Screening Array 4.0 (GSA 4.0): Genomic analyses

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
25 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Diagnosis of mood disorder (major depressive episode, major depressive disorder, or bipolar disorder) according to DSM-5; * Age between 18 and 25 years; * Eligibility for magnetic resonance imaging; * Proficiency in the Italian language. Exclusion Criteria: * Comorbidity with severe neurological or medical conditions; * Diagnosis of cognitive impairment; * Inability to provide informed consent. For the control group: Inclusion Criteria: the same as the experimental group. Exclusion Criteria: * subjects with DSM-5 disorders * subjects with a family history of psychiatric disorders will be excluded.

Primary outcome measure(s)

  • Change of suicidal risk — 3 months
    Reduction of suicidal risk, assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) score (No, Low, Moderate, High)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenza Roma RM Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07188506 on ClinicalTrials.gov ↗ ← All trials in Italy