Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People (YOU-SURF)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Suicidal Ideation; Suicide, Attempted; Suicide Prevention; Mood Disorders

Treatments: Device: dTMS treatment; Diagnostic Test: Clinical and blood parameters; Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)

Study type: Interventional

Funder types: Other

Identifiers

NCT07188506

8012 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Suicidal clinic group

Experimental group

Description:

60 patients at suicidal risk

Treatment:

Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)

Diagnostic Test: Clinical and blood parameters

Device: dTMS treatment

Not-Suicidal clinic group

Experimental group

Description:

60 patients without suicidal risk

Treatment:

Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)

Diagnostic Test: Clinical and blood parameters

Device: dTMS treatment

Healthy Controls

Active Comparator group

Description:

60 healthy controls (HCs)

Treatment:

Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)

Diagnostic Test: Clinical and blood parameters