NCT07188506: YOU-SURF

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

Not yet recruiting NA Last updated 29 September 2025

What this trial tests

NA trial testing Clinical and blood parameters in Mood Disorders in 180 participants. Not yet recruiting.

Timeline

31 October 2025

Primary endpoint
31 December 2027

31 October 2028

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	180
Start date	31 October 2025
Primary completion	31 December 2027
Estimated completion	31 October 2028
Sites	1 location across Italy

Drugs / interventions tested

• Clinical and blood parameters
• Illumina Infinium Global Screening Array 4.0 (GSA 4.0)
• dTMS treatment

Conditions studied

• Mood Disorders — all drugs for Mood Disorders →
• Suicide, Attempted — all drugs for Suicide, Attempted →
• Suicidal Ideation — all drugs for Suicidal Ideation →
• Suicide Prevention — all drugs for Suicide Prevention →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Adults 18 to 25, any sex, with Mood Disorders or Suicide, Attempted. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.