As of October 5, 2025, researchers at Fondazione Policlinico Universitario Agostino Gemelli IRCCS are initiating a clinical trial aimed at reducing suicide risk factors among youth. This trial integrates advanced medical devices and diagnostic innovations to better understand and address contributing conditions such as mood disorders, suicidal ideation, and previous suicide attempts.
The study, titled ‘Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People,’ will investigate cutting-edge methods like Deep Transcranial Magnetic Stimulation (dTMS) treatment and genetic screening tools to inform suicide prevention strategies. Stakeholders in clinical research, quality assurance, and regulatory affairs should closely monitor this trial’s outcomes to assess compliance, efficacy, and potential implications for medical device applications.
In this article:
- What is this study about?
- What technologies are involved?
- Who sponsors and what are the objectives?
- FAQs
- What are the implications?
- Disclaimer
- Full details
What is this study about?
Youth suicide rates continue to be a significant global challenge. Recognizing the need for targeted interventions, this clinical trial focuses on diagnosing and addressing suicide risk factors. It combines clinical insights with innovative technologies to evaluate their effectiveness in mitigating risks. Conditions under study include mood disorders, suicidal ideation, and attempted suicides.
Participants will be evaluated using clinical tests, blood parameters, and genetic analyses. The trial aims to develop new strategies for prevention tailored specifically to vulnerable youth populations.
What technologies are involved?
Key interventions include:
- Clinical and blood parameter diagnostics: These tests help identify biological markers associated with elevated suicide risk.
- Genetic screening: Using Illumina Infinium Global Screening Array 4.0 (GSA 4.0), researchers aim to uncover genetic predispositions linked to psychiatric conditions and suicidal tendencies.
- Deep Transcranial Magnetic Stimulation (dTMS): This device-based treatment targets brain regions involved in mood regulation, offering a non-invasive intervention method.
The inclusion of dTMS represents a significant advance in medical device technologies, aligning with MDR safety and performance requirements for therapeutic applications.
Who sponsors and what are the objectives?
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the trial’s sponsor, reflecting their commitment to advancing suicide prevention research. Their objectives include:
- Identifying key risk markers for youth suicide.
- Developing actionable insights for clinical interventions.
- Exploring the regulatory and safety profiles of emerging medical devices like dTMS.
The trial is currently listed as ‘Not yet recruiting,’ but stakeholders should monitor updates through the provided link.
FAQ
1. Who can participate in this trial?
The eligibility criteria will be outlined during the recruitment phase. Youth experiencing mood disorders or suicidal ideation are likely candidates.
2. Are these technologies cleared for clinical use?
dTMS devices comply with current medical device regulations, while genetic arrays are widely used in research settings. This trial aims to evaluate their combined efficacy for suicide prevention.
3. How can stakeholders stay informed?
Visit the ClinicalTrials.gov link for updates or subscribe to relevant medical journals and newsletters focusing on suicide prevention and device innovation.
What are the implications?
This clinical trial has the potential to reshape approaches to youth suicide prevention. It could pave the way for incorporating advanced diagnostics and treatment devices into broader clinical practice. For regulatory teams, evaluating the safety and performance of technologies like dTMS remains critical.
The study’s outcomes could also inform policy changes, particularly concerning the integration of genetic screening and non-invasive treatment devices into standard care protocols. Interested parties should assess how findings might influence device registration and future clinical guidelines.
Disclaimer
This article is intended for informational purposes only. It does not constitute legal or regulatory advice. Professionals should rely on official sources and regulatory documentation for compliance guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07188506?term=medical+device