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

Youth Suicide Risk Factors: Clinical, Neuroimaging, Genetic, and Microbiome Insights, and Predictors of Response to Deep Transcranial Magnetic Stimulation (dTMS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07188506
Acronym
YOU-SURF
Enrollment
180
Registered
2025-09-23
Start date
2025-11-15
Completion date
2028-10-31
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood Disorders, Suicidal Ideation, Suicide, Attempted, Suicide Prevention

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: 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_TESTClinical and blood parameters

Clinical data and MRI measurements

GENETICIllumina Infinium Global Screening Array 4.0 (GSA 4.0)

Genomic analyses

DEVICEdTMS treatment

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change of suicidal risk3 monthsReduction of suicidal risk, assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) score (No, Low, Moderate, High)

Secondary

MeasureTime frameDescription
Severity of depressive symptoms3 monthsSeverity of depressive symptoms, assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS): 0 to 6: normal/symptom absent 7 to 19: mild depression 20 to 34: moderate depression 35 to 60: severe depression
General psychiatric symptoms3 monthsGeneral psychiatric symptoms measured with the Brief Psychiatric Rating Scale (BPRS). The rater enters a number for each symptom construct that ranges from 1 (not present) to 7 (extremely severe).

Countries

Italy

Contacts

CONTACTDelfina Janiri
delfina.janiri@unicatt.it+390630159527
PRINCIPAL_INVESTIGATORDelfina Janiri

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026