Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical and blood parameters, Illumina Infinium Global Screening Array 4.0 (GSA 4.0), dTMS treatment.
- Who it may be relevant to
- Registry conditions: Mood Disorders, Suicide, Attempted, Suicidal Ideation, Suicide Prevention. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Youth Suicide Risk Factors: Clinical, Neuroimaging, Genetic, and Microbiome Insights, and Predictors of Response to Deep Transcranial Magnetic Stimulation (dTMS)
Overview
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.
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
Primary outcome measures
- Change of suicidal risk [Time frame: 3 months]
Secondary outcome measures (2)
- Severity of depressive symptoms [Time frame: 3 months]
- General psychiatric symptoms [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenz — Roma
Identifiers
NCT: NCT07188506 · 8012