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

NCT07188506 | Not Yet Recruiting

• 1 other identifier: 8012
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 1.To identify youth suicide risk factors through the integration of clinical, environmental, neuroimaging, genetic, and microbiome data;
2. 2.To longitudinally evaluate the effectiveness of dTMS in the treatment of young people at risk of suicide;
3. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change of suicidal risk

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

  3 months

Secondary Outcomes (2)

• Severity of depressive symptoms

  3 months

• General psychiatric symptoms

  3 months

Study Arms (3)

Suicidal clinic group

EXPERIMENTAL

60 patients at suicidal risk

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

Not-Suicidal clinic group

EXPERIMENTAL

60 patients without suicidal risk

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

Healthy Controls

ACTIVE COMPARATOR

60 healthy controls (HCs)

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

Interventions

Clinical and blood parameters DIAGNOSTIC_TEST

Clinical data and MRI measurements

Also known as: Magnetic Resonance Imaging (MRI) protocol

Healthy Controls; Not-Suicidal clinic group; Suicidal clinic group

Illumina Infinium Global Screening Array 4.0 (GSA 4.0) GENETIC

Genomic analyses

Also known as: Microbiota protocol

Healthy Controls; Not-Suicidal clinic group; Suicidal clinic group

dTMS treatment DEVICE

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

Not-Suicidal clinic group; Suicidal clinic group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Comorbidity with severe neurological or medical conditions;
• Diagnosis of cognitive impairment;
• Inability to provide informed consent.
• For the control group:
• the same as the experimental group.
• subjects with DSM-5 disorders
• subjects with a family history of psychiatric disorders will be excluded.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenza

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

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

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Delfina Janiri

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delfina Janiri

CONTACT

+390630159527; delfina.janiri@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

IT (1)