跳至主要内容
临床试验/NCT07188506
NCT07188506招募中不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS3 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
3
主要终点
Change of suicidal risk

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Suicidal clinic group

Experimental

60 patients at suicidal risk

干预措施: Clinical and blood parameters (Diagnostic Test)

Suicidal clinic group

Experimental

60 patients at suicidal risk

干预措施: Illumina Infinium Global Screening Array 4.0 (GSA 4.0) (Genetic)

Suicidal clinic group

Experimental

60 patients at suicidal risk

干预措施: dTMS treatment (Device)

Healthy Controls

Active Comparator

60 healthy controls (HCs)

干预措施: Clinical and blood parameters (Diagnostic Test)

Healthy Controls

Active Comparator

60 healthy controls (HCs)

干预措施: Illumina Infinium Global Screening Array 4.0 (GSA 4.0) (Genetic)

Not-Suicidal clinic group

Experimental

60 patients without suicidal risk

干预措施: Clinical and blood parameters (Diagnostic Test)

Not-Suicidal clinic group

Experimental

60 patients without suicidal risk

干预措施: Illumina Infinium Global Screening Array 4.0 (GSA 4.0) (Genetic)

Not-Suicidal clinic group

Experimental

60 patients without suicidal risk

干预措施: dTMS treatment (Device)

结局指标

主要结局

Change of suicidal risk

时间窗: 3 months

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

次要结局

  • Severity of depressive symptoms(3 months)
  • General psychiatric symptoms(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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