Youth Suicide Risk Factors: Clinical, Neuroimaging, Genetic, and Microbiome Insights, and Predictors of Response to Deep Transcranial Magnetic Stimulation (dTMS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change of suicidal risk
Study Overview
Brief 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:
- To identify youth suicide risk factors through the integration of clinical, environmental, neuroimaging, genetic, and microbiome data;
- To longitudinally evaluate the effectiveness of dTMS in the treatment of young people at risk of suicide;
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Suicidal clinic group
60 patients at suicidal risk
Intervention: Clinical and blood parameters (Diagnostic Test)
Suicidal clinic group
60 patients at suicidal risk
Intervention: Illumina Infinium Global Screening Array 4.0 (GSA 4.0) (Genetic)
Suicidal clinic group
60 patients at suicidal risk
Intervention: dTMS treatment (Device)
Healthy Controls
60 healthy controls (HCs)
Intervention: Clinical and blood parameters (Diagnostic Test)
Healthy Controls
60 healthy controls (HCs)
Intervention: Illumina Infinium Global Screening Array 4.0 (GSA 4.0) (Genetic)
Not-Suicidal clinic group
60 patients without suicidal risk
Intervention: Clinical and blood parameters (Diagnostic Test)
Not-Suicidal clinic group
60 patients without suicidal risk
Intervention: Illumina Infinium Global Screening Array 4.0 (GSA 4.0) (Genetic)
Not-Suicidal clinic group
60 patients without suicidal risk
Intervention: dTMS treatment (Device)
Outcomes
Primary Outcomes
Change of suicidal risk
Time Frame: 3 months
Reduction of suicidal risk, assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) score (No, Low, Moderate, High)
Secondary Outcomes
- Severity of depressive symptoms(3 months)
- General psychiatric symptoms(3 months)