Mood DisordersYOU-SURFNCT07188506
Youth Suicide Risk Factors, Reduction of Suicide Risk Factor in Youth People
A study testing Clinical and blood parameters, Illumina Infinium Global Screening Array 4.0 (GSA 4.0) and dTMS treatment in people with Mood Disorders and Suicide, Attempted, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Clinical and blood parameters, Illumina Infinium Global Screening Array 4.0 (GSA 4.0) and dTMS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2025to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- the same as the experimental group.
Who cannot join
- Comorbidity with severe neurological or medical conditions;
- Diagnosis of cognitive impairment;
- Inability to provide informed consent.
- For the control group:
- subjects with DSM-5 disorders
- subjects with a family history of psychiatric disorders will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - UOC Psichiatria Clinica e d'Urgenza
Roma, RM, 00168
Delfina Janiri, +390630159527, delfina.janiri@unicatt.it
Mario Pinto, mario.pinto@guest.policlinicogemelli.it
About this study
Official title: Youth Suicide Risk Factors: Clinical, Neuroimaging, Genetic, and Microbiome Insights, and Predictors of Response to Deep Transcranial Magnetic Stimulation (dTMS)
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.
Read more
The specific objectives of the project are as follows:
- To identify youth suicide risk factors through the integration of clinical, environmental, neuroimaging, genetic, and microbiome data;
- To longitudinally evaluate the effectiveness of dTMS in the treatment of young people at risk of suicide;
- 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.
- Being tested
- Clinical and blood parameters, Illumina Infinium Global Screening Array 4.0 (GSA 4.0), dTMS treatment
- Medical subject headings
- Mood Disorders, Suicide, Attempted, Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and blood parametersDiagnostic test
Also called Magnetic Resonance Imaging (MRI) protocol
Clinical data and MRI measurements
Illumina Infinium Global Screening Array 4.0 (GSA 4.0)Genetic
Also called Microbiota protocol
Genomic analyses
dTMS treatmentDevice
high-intensity deep transcranial magnetic stimulation (dTMS) device recognized for clinical application in mood disorders
| Study group | Role | What they receive |
|---|---|---|
| Suicidal clinic group | Experimental | 60 patients at suicidal risk Receives: 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 Receives: 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) Receives: Diagnostic Test: Clinical and blood parameters; Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of suicidal risk
Reduction of suicidal risk, assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) score (No, Low, Moderate, High)
Measured: 3 months
Secondary outcomes (2)
Severity of depressive symptoms
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
Measured: 3 months
General psychiatric symptoms
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start15 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delfina Janiri, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188506
- Sponsor's protocol ID
- 8012
- Acronym
- YOU-SURF
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Suicide Risk Factors: Clinical, Neuroimaging, Genetic, and Microbiome Insights, and Predictors of Response to Deep Transcranial Magnetic Stimulation (dTMS)
- ClinicalTrials.gov ID
- NCT07188506
- Acronym / sponsor ID
- YOU-SURF / 8012
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To identify youth suicide risk factors through the integration of clinical, environmental, neuroimaging, genetic, and microbiome data;
- To longitudinally evaluate the effectiveness of dTMS in the treatment of young people at risk of suicide;
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suicidal clinic group | Experimental | Diagnostic Test: Clinical and blood parameters, Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0), Device: dTMS treatment60 patients at suicidal risk |
| Not-Suicidal clinic group | Experimental | Diagnostic Test: Clinical and blood parameters, Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0), Device: dTMS treatment60 patients without suicidal risk |
| Healthy Controls | Active comparator | Diagnostic Test: Clinical and blood parameters, Genetic: Illumina Infinium Global Screening Array 4.0 (GSA 4.0)60 healthy controls (HCs) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- the same as the experimental group.
Key exclusion criteria (6 listed)
- Comorbidity with severe neurological or medical conditions;
- Diagnosis of cognitive impairment;
- Inability to provide informed consent.
- subjects with DSM-5 disorders
- subjects with a family history of psychiatric disorders will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and blood parametersAlso: Magnetic Resonance Imaging (MRI) protocolClinical data and MRI measurements | Diagnostic test | Healthy Controls, Not-Suicidal clinic group, Suicidal clinic group |
| Illumina Infinium Global Screening Array 4.0 (GSA 4.0)Also: Microbiota protocolGenomic analyses | Genetic | Healthy Controls, Not-Suicidal clinic group, Suicidal clinic group |
| dTMS treatmenthigh-intensity deep transcranial magnetic stimulation (dTMS) device recognized for clinical application in mood disorders | Device | Not-Suicidal clinic group, Suicidal clinic group |
Primary outcome
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)
2 secondary outcomes
Severity of depressive symptoms
Time frame: 3 months
General psychiatric symptoms
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delfina Janiri principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and blood parameters, Illumina Infinium Global Screening Array 4.0 (GSA 4.0) and dTMS treatment in people with Mood Disorders and Suicide, Attempted, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delfina Janiri (+390630159527, delfina.janiri@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of suicidal risk (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.