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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07188506
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Study Start: 2025-10-31
• Primary Completion: 2027-12-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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, subjects with DSM-5 disorders or a family history of psychiatric disorders will be excluded. The other eligibility criteria will be identical to those established for the patient groups. Suicidal risk will be defined based on the cut-off scores of the Columbia Suicide Severity Rating Scale (C-SSRS).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reduction of suicidal risk	3 months	Reduction of suicidal risk, assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) score (No, Low, Moderate, High)

Secondary Outcome Measures

Name	Time	Method
Severity of depressive symptoms	3 months	Severity 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 symptoms	3 months	General 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).

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenza; 🇮🇹 Roma, RM, Italy