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NCT Number: NCT07188506

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Roma, RM, 00168, Italy

Location contact

Delfina Janiri

CONTACT

[email protected]

+390630159527

Delfina Janiri

PRINCIPAL_INVESTIGATOR

Gabriele Sani

SUB_INVESTIGATOR

Mario Pinto

CONTACT

[email protected]

Silvia Montanari

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical and blood parameters

Diagnostic Test

Clinical data and MRI measurements

Other names: Magnetic Resonance Imaging (MRI) protocol

Illumina Infinium Global Screening Array 4.0 (GSA 4.0)

Genetic

Genomic analyses

Other names: Microbiota protocol

dTMS treatment

Device

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

Primary outcomes

  1. 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

  1. Severity of depressive symptoms

    Time frame: 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

  2. General psychiatric symptoms

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Delfina Janiri

CONTACT

[email protected]

+390630159527

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: YOU-SURF

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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