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Набор скоро начнётся NCT07188506

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

Без фазы С лечением Mood Disorders Suicide, Attempted Suicidal Ideation Suicide Prevention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Clinical and blood parameters, Illumina Infinium Global Screening Array 4.0 (GSA 4.0), dTMS treatment.
Кому может быть актуально
Состояния в реестре: Mood Disorders, Suicide, Attempted, Suicidal Ideation, Suicide Prevention. Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Диагностический тест Clinical and blood parameters
    Clinical data and MRI measurements
  • Генная терапия Illumina Infinium Global Screening Array 4.0 (GSA 4.0)
    Genomic analyses
  • Устройство dTMS treatment
    high-intensity deep transcranial magnetic stimulation (dTMS) device recognized for clinical application in mood disorders

Первичные конечные точки

  • Change of suicidal risk [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • Severity of depressive symptoms [Срок оценки: 3 months]
  • General psychiatric symptoms [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Comorbidity with severe neurological or medical conditions;
  • Diagnosis of cognitive impairment;
  • Inability to provide informed consent.

For the control group:

Критерии включения

the same as the experimental group.

Критерии исключения

  • subjects with DSM-5 disorders
  • subjects with a family history of psychiatric disorders will be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Италия · 1 центр
  • Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenz — Roma

Идентификаторы

NCT: NCT07188506 · 8012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗