Suicide AttemptSMARTomicS-RNCT07422090
Preventing Suicide With Digital Phenotyping and Pharmacogenetics-Based Interventions
An observational study of Suicide Attempt, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The goal of this protocol for an observational retrospective multi-site cohort study is to develop a predictive algorithm for suicidal behavior integrating genetic risk markers, digital phenotypes, and exposomic data in people with a lifetime history of suicide attempt. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Suicide Attempt
- How many people
- 5,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2025to Jan 2028
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatients with a lifetime history of suicide attempt
Who may be able to join
- At least one suicide attempt in their lifetime.
- The attempt must have occurred when the participant was older than 12 years old.
- Participants must be at least 18 years old or have parental consent if aged 12-17.
Who cannot join
- medical contraindication prevents blood sample collection
- unable to provide informed consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto Fundación Jiménez Díaz
Madrid, Madrid, 28040
Enrique Baca-García Chief of the psychiatry department, +34 915 50 48 00, ebaca@fjd.es
About this study
Official title: Prevention of Suicidal Behavior Through Therapeutic Interventions Guided by Digital Phenotype and Pharmacogenetics: The SMARTomicS Study Protocol
The goal of this protocol for an observational retrospective multi-site cohort study is to develop a predictive algorithm for suicidal behavior integrating genetic risk markers, digital phenotypes, and exposomic data in people with a lifetime history of suicide attempt. Participants will be aged from 12 onwards (requiring parental consent if under 18) and only be excluded if they are unable to provide a genetic sample or do not consent to the study. The main question[s] it aims to answer is:
- Can genotyping/omics analysis of individuals with a history of suicidal behaviuor reveal potential genetic factors associated with suicide risk?
Read more
Secondary questions include:
- Can behavioral factors associated with suicide risk be explored through data obtained from Google Takeout?
- Is there an association between medication changes and suicidal behavior, as identified through the Unified Prescription Module and the Digital Health Record?
- Do different suicidal phenotypes differ based on the collected variables?
- Can the investigators construct an exposome using geolocated and time-stamped data from Google Takeout, combined anonymously with data from the National Statistics and Meteorology Institutes?
The investigators hypothesize that:
- Individuals with a history of suicidal behavior will show significant genotypic differences compared to the general population (based on Spanish Genome Project data).
- Suicidal phenotypes-especially between single and multiple attempters-will differ across collected variables, including genotype, omics, and exposome data. participants will complete genetic assessments, digital phenotypes, clinical questionnaires and exposomic data
Read the detailed description
Participant recruitment will occur in person at outpatient mental health clinics, emergency departments, and short-stay hospital units. Mental health professionals (psychiatrists, psychologists, and nurses) will assess eligibility during clinical encounters, provide study information, and obtain informed consent. Data will be entered into the MeMind environment for data monitoring, and patient validation, ensuring eligibility criteria and noting any missing information.
Prior to recruitment, training sessions and standardized guidelines are provided to healthcare professionals to ensure adherence to the study protocol.
Data will be verified against INE statistics and hospital records to assess the representativeness and completeness of the data.
The primary outcome is suicidal behavior risk, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), the Brugha scale, documented suicidal events, healthcare utilization, behavioral patterns, digital phenotyping, and pharmacological treatment modifications. Secondary outcomes include evaluating the efficacy of pharmacological treatments and the cost-effectiveness of genetic markers in guiding antidepressant selection.
Baseline data collection includes:
- Genetic sampling for genomic and metabolic profiling.
- A sociodemographic and clinical assessment.
- Consent-based extraction of digital behavioral data via Google Takeout.
To enrich participant health profiles, retrospective data from electronic health records (EHRs), prescription registries, and sociodemographic indicators from the Spanish National Institute of Statistics (INE) will be integrated. EHR data will include the Basic Minimum Set of Data (BMSD), a standardized clinical-administrative dataset. Blood samples will allow for DNA/RNA extraction and metabolomic analyses. Genetic findings will be compared with GWAS summary statistics from the Psychiatric Genomics Consortium (PGC) on suicide attempts and validated against control samples from the Banco Nacional de ADN and the Madrid Manic Group cohort.
Google Takeout data will be used to construct digital phenotypes. Patients will choose which data to share, supported by a research assistant. The selected data will be pseudonymized via a secure script before being stored on servers at Universidad Carlos III. Prescription histories from various autonomous regions will be analyzed to monitor treatment trajectories over time.
This study is part of a national consortium targeting a sample of at least 5,000 participants. Power calculations, informed by a recent meta-analysis (Li, 2023), indicate that this sample size would yield 93.5% power at a genome-wide significance level (p < 5×10-⁸), assuming a minor allele frequency of 0.2 and an odds ratio of 1.3, accounting for gender, diagnosis, and treatment response variability.
Statistical analyses will be conducted using SPSS software version 29.0. Logistic regression models will be used to examine factors associated with the primary outcomes, and a multivariate regression model will be developed to assess independent associations. All tests will be two-tailed, with statistical significance defined as p < 0.05 and 95% confidence intervals reported.
To identify digital behavioral biomarkers, advanced statistical and machine learning techniques will be applied. Individualized suicide-related profiles will be generated and compared using integrated data from genetic, metabolic, medical, and digital phenotyping sources. Additionally, a personalized and anonymized exposome will be constructed by combining geo-temporal data from Google Takeout with contextual information from public sociodemographic datasets (e.g., INE).
- Conditions
- Suicide Attempt
- Being tested
- No Intervention: Observational Cohort
- Keywords
- suicide, suicide attempt, suicidal ideation, phenotyping, digital medicine, eHealth, genetic, exposome
- Medical subject headings
- Suicide, Attempted, Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortGenetic
Genetic analysis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Our only group consists of people with a lifetime history of suicide attempt Receives: Genetic: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide attempt
Aim to explore associated factors to suicide attempt
Measured: Baseline assessment; lifetime suicide attempts occurring from age 12 until enrollment.
Secondary outcomes (2)
pharmacological treatment efficacy
Efficacy of different pharmacological treatments for suicide prevention
Measured: Assessed at baseline; retrospective evaluation of pharmacological treatments received prior to enrollment.
cost-effectiveness of genetic markers
retrospective cost-effectiveness analysis of genetic markers to guide antidepressant treatments based on treatments received prior to enrollment
Measured: Baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Rey Juan Carlos, Hospitales Universitarios Virgen del Rocío, University of Seville, Universidad de Zaragoza, Universidad de Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias - ISPA, Centro de Investigación Biomédica en Red de Salud Mental, Hospital Miguel Servet, Servicio de Salud del Principado de Asturias. Área Sanitaria III, Fundació d'investigació Sanitària de les Illes Balears, University of Castilla-La Mancha, Hospital del Mar Research Institute (IMIM), Hospital de Aviles, Universitat Pompeu Fabra, University of Barcelona, Hospital Clinic of Barcelona, Corporacion Parc Tauli, Universitat Autonoma de Barcelona, Institut de Recerca Biomèdica de Lleida, Hospital Clínico Universitario de Valencia, University of Valencia, Hospital Universitario La Fe, Hospital Provincial de Castellon, Universidad de Extremadura, University of Santiago de Compostela, Centre Hospitalier Universitaire de Nīmes, Centro de Investigación en Red de Enfermedades Raras (CIBERER), Servicio Gallego de Salud, Universidad Autonoma de Madrid, Universidad Complutense de Madrid, Hospital Universitario La Paz, Centro de Biología Molecular Severo Ochoa, Spain (CBMSO), Fundación General CSIC, Neuroscience Research Australia, The University of New South Wales, Hospital General Universitario Gregorio Marañon, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Carlos III de Madrid, Hospital San Carlos, Madrid, Hospital Universitario Ramon y Cajal, University of Alcala, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal, Hospital Universitario de Móstoles, Universidad Rey Juan Carlos, Hospital Universitario Infanta Elena, Hospital Universitario 12 de Octubre, Fundación Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Médica Aplicada (CIMA), Hospital Universitario Araba, Bioaraba Health Research Institute, Euskal Herriko Universitatea - Universidad del País Vasco. Qualiker., Universidad Católica del Maule
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422090
- Sponsor's protocol ID
- PIC301-24_FJD
- Acronym
- SMARTomicS-R
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DiBlasi E, Kang J, Docherty AR. Genetic contributions to suicidal thoughts and behaviors. Psychol Med. 2021 Oct;51(13):2148-2155. doi: 10.1017/S0033291721001720. Epub 2021 May 25.
PubMed 34030748Rejek M, Misiak B. The Associations of Exposome Score with Various Domains of Psychopathology: A Network Analysis in a Non-Clinical Sample. Brain Sci. 2024 Feb 29;14(3):242. doi: 10.3390/brainsci14030242.
PubMed 38539630Visoki E, Moore TM, Zhang X, Tran KT, Ly C, Gatavins MM, DiDomenico GE, Brogan L, Fein JA, Warrier V, Guloksuz S, Barzilay R. Classification of Suicide Attempt Risk Using Environmental and Lifestyle Factors in 3 Large Youth Cohorts. JAMA Psychiatry. 2024 Oct 1;81(10):1020-1029. doi: 10.1001/jamapsychiatry.2024.1887.
PubMed 39018056Vineis P, Chadeau-Hyam M, Gmuender H, Gulliver J, Herceg Z, Kleinjans J, Kogevinas M, Kyrtopoulos S, Nieuwenhuijsen M, Phillips DH, Probst-Hensch N, Scalbert A, Vermeulen R, Wild CP; EXPOsOMICS Consortium. The exposome in practice: Design of the EXPOsOMICS project. Int J Hyg Environ Health. 2017 Mar;220(2 Pt A):142-151. doi: 10.1016/j.ijheh.2016.08.001. Epub 2016 Aug 19.
PubMed 27576363Abascal-Peiro S, Penuelas-Calvo I, Alacreu-Crespo A, Saiz PA, De la Torre-Luque A, Ruiz-Veguilla M, Barrigon ML, Courtet P, Lopez-Castroman J, Baca-Garcia E, Porras-Segovia A. Digital Platform for the Prevention of Suicidal Behaviour and Non-Suicidal Self-Injuries in Adolescents: The SmartCrisis-Teen Study Protocol. Behav Sci (Basel). 2024 Aug 25;14(9):740. doi: 10.3390/bs14090740.
PubMed 39335956Porras-Segovia A, Diaz-Olivan I, Barrigon ML, Moreno M, Artes-Rodriguez A, Perez-Rodriguez MM, Baca-Garcia E. Real-world feasibility and acceptability of real-time suicide risk monitoring via smartphones: A 6-month follow-up cohort. J Psychiatr Res. 2022 May;149:145-154. doi: 10.1016/j.jpsychires.2022.02.026. Epub 2022 Mar 3.
PubMed 35276631Barrigon ML, Romero-Medrano L, Moreno-Munoz P, Porras-Segovia A, Lopez-Castroman J, Courtet P, Artes-Rodriguez A, Baca-Garcia E. One-Week Suicide Risk Prediction Using Real-Time Smartphone Monitoring: Prospective Cohort Study. J Med Internet Res. 2023 Sep 1;25:e43719. doi: 10.2196/43719.
PubMed 37656498de la Torre-Luque A, Pemau A, Ayad-Ahmed W, Borges G, Fernandez-Sevillano J, Garrido-Torres N, Garrido-Sanchez L, Garriga M, Gonzalez-Ortega I, Gonzalez-Pinto A, Grande I, Guinovart M, Hernandez-Calle D, Jimenez-Trevino L, Lopez-Sola C, Mediavilla R, Perez-Aranda A, Ruiz-Veguilla M, Seijo-Zazo E, Toll A, Perez-Sola V, Ayuso-Mateos JL; SURVIVE Consortium. Risk of suicide attempt repetition after an index attempt: A systematic review and meta-analysis. Gen Hosp Psychiatry. 2023 Mar-Apr;81:51-56. doi: 10.1016/j.genhosppsych.2023.01.007. Epub 2023 Jan 23.
PubMed 36805332Martinez-Ales G, Cruz Rodriguez JB, Lazaro P, Domingo-Relloso A, Barrigon ML, Angora R, Rodriguez-Vega B, Jimenez-Sola E, Sanchez-Castro P, Roman-Mazuecos E, Villoria L, Ortega AJ, Navio M, Stanley B, Rosenheck R, Baca-Garcia E, Bravo-Ortiz MF. Cost-effectiveness of a Contact Intervention and a Psychotherapeutic Program for Post-discharge Suicide Prevention. Can J Psychiatry. 2021 Aug;66(8):737-746. doi: 10.1177/0706743720980135. Epub 2020 Dec 15.
PubMed 33317338Artes C, Porras-Segovia A, Ruiz-Veguilla M, Giner L, Garcia-Campayo J, Lopez Del Hoyo Y, Alejandra-Saiz P, Garcia-Fernandez A, Martinez-Jambrina JJ, Villa-Diez R, Gili M, Roca M, de Andres F, Perez Sola V, Elices ME, Grande I, Cebria AI, Irigoyen-Otinano M, Galvan-Santiago L, Garcia-Iturrospe EJA, Mesones-Peral J, Mora-Marin R, Sierra P, Penas-Lledo E, LLerena A, Lopez-Castroman J, Cruz R, Arrojo M, Ovejero S, de la Torre-Luque A, Palao-Tarrero A, Vaquero-Lorenzo C, Toma C, Barrigon ML, Artes A, Diaz-Marsa M, Ayad-Ahmed W, Ibanez A, Diaz-Sastre C, Salvador-Robert M, Alvarez-Garcia R, Mata-Iturralde L, Benavente-Lopez S, Munoz-Lorenzo L, Di Stasio EF, Carmona-Camacho R, Penuelas-Calvo I, Valencia M, Lopez Pena P, Albarracin-Garcia L, Baca-Garcia E. Designing interventions guided by digital phenotype and pharmacogenetics in Spain for suicidal behaviour based on retrospective data: the multicentre SMARTomicS study protocol. BMJ Open. 2026 May 20;16(5):e106685. doi: 10.1136/bmjopen-2025-106685.
PubMed 42161558
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Suicidal Behavior Through Therapeutic Interventions Guided by Digital Phenotype and Pharmacogenetics: The SMARTomicS Study Protocol
- ClinicalTrials.gov ID
- NCT07422090
- Acronym / sponsor ID
- SMARTomicS-R / PIC301-24_FJD
- Conditions
- Suicide Attempt
- Keywords
- suicide, suicide attempt, suicidal ideation, phenotyping, digital medicine, eHealth, genetic, exposome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Rey Juan Carlos, Hospitales Universitarios Virgen del Rocío, University of Seville, Universidad de Zaragoza, Universidad de Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias - ISPA, Centro de Investigación Biomédica en Red de Salud Mental, Hospital Miguel Servet, Servicio de Salud del Principado de Asturias. Área Sanitaria III, Fundació d'investigació Sanitària de les Illes Balears, University of Castilla-La Mancha, Hospital del Mar Research Institute (IMIM), Hospital de Aviles, Universitat Pompeu Fabra, University of Barcelona, Hospital Clinic of Barcelona, Corporacion Parc Tauli, Universitat Autonoma de Barcelona, Institut de Recerca Biomèdica de Lleida, Hospital Clínico Universitario de Valencia, University of Valencia, Hospital Universitario La Fe, Hospital Provincial de Castellon, Universidad de Extremadura, University of Santiago de Compostela, Centre Hospitalier Universitaire de Nīmes, Centro de Investigación en Red de Enfermedades Raras (CIBERER), Servicio Gallego de Salud, Universidad Autonoma de Madrid, Universidad Complutense de Madrid, Hospital Universitario La Paz, Centro de Biología Molecular Severo Ochoa, Spain (CBMSO), Fundación General CSIC, Neuroscience Research Australia, The University of New South Wales, Hospital General Universitario Gregorio Marañon, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Carlos III de Madrid, Hospital San Carlos, Madrid, Hospital Universitario Ramon y Cajal, University of Alcala, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal, Hospital Universitario de Móstoles, Universidad Rey Juan Carlos, Hospital Universitario Infanta Elena, Hospital Universitario 12 de Octubre, Fundación Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Médica Aplicada (CIMA), Hospital Universitario Araba, Bioaraba Health Research Institute, Euskal Herriko Universitatea - Universidad del País Vasco. Qualiker., Universidad Católica del Maule
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 19 Feb 2026 (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 goal of this protocol for an observational retrospective multi-site cohort study is to develop a predictive algorithm for suicidal behavior integrating genetic risk markers, digital phenotypes, and exposomic data in people with a lifetime history of suicide attempt. Participants will be aged from 12 onwards (requiring parental consent if under 18) and only be excluded if they are unable to provide a genetic sample or do not consent to the study. The main question[s] it aims to answer is:
- Can genotyping/omics analysis of individuals with a history of suicidal behaviuor reveal potential genetic factors associated with suicide risk?
Secondary questions include:
- Can behavioral factors associated with suicide risk be explored through data obtained from Google Takeout?
- Is there an association between medication changes and suicidal behavior, as identified through the Unified Prescription Module and the Digital Health Record?
- Do different suicidal phenotypes differ based on the collected variables?
- Can the investigators construct an exposome using geolocated and time-stamped data from Google Takeout, combined anonymously with data from the National Statistics and Meteorology Institutes?
The investigators hypothesize that:
- Individuals with a history of suicidal behavior will show significant genotypic differences compared to the general population (based on Spanish Genome Project data).
- Suicidal phenotypes-especially between single and multiple attempters-will differ across collected variables, including genotype, omics, and exposome data. participants will complete genetic assessments, digital phenotypes, clinical questionnaires and exposomic data
Detailed description
Participant recruitment will occur in person at outpatient mental health clinics, emergency departments, and short-stay hospital units. Mental health professionals (psychiatrists, psychologists, and nurses) will assess eligibility during clinical encounters, provide study information, and obtain informed consent. Data will be entered into the MeMind environment for data monitoring, and patient validation, ensuring eligibility criteria and noting any missing information.
Prior to recruitment, training sessions and standardized guidelines are provided to healthcare professionals to ensure adherence to the study protocol.
Data will be verified against INE statistics and hospital records to assess the representativeness and completeness of the data.
The primary outcome is suicidal behavior risk, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), the Brugha scale, documented suicidal events, healthcare utilization, behavioral patterns, digital phenotyping, and pharmacological treatment modifications. Secondary outcomes include evaluating the efficacy of pharmacological treatments and the cost-effectiveness of genetic markers in guiding antidepressant selection.
Baseline data collection includes:
- Genetic sampling for genomic and metabolic profiling.
- A sociodemographic and clinical assessment.
- Consent-based extraction of digital behavioral data via Google Takeout.
To enrich participant health profiles, retrospective data from electronic health records (EHRs), prescription registries, and sociodemographic indicators from the Spanish National Institute of Statistics (INE) will be integrated. EHR data will include the Basic Minimum Set of Data (BMSD), a standardized clinical-administrative dataset. Blood samples will allow for DNA/RNA extraction and metabolomic analyses. Genetic findings will be compared with GWAS summary statistics from the Psychiatric Genomics Consortium (PGC) on suicide attempts and validated against control samples from the Banco Nacional de ADN and the Madrid Manic Group cohort.
Google Takeout data will be used to construct digital phenotypes. Patients will choose which data to share, supported by a research assistant. The selected data will be pseudonymized via a secure script before being stored on servers at Universidad Carlos III. Prescription histories from various autonomous regions will be analyzed to monitor treatment trajectories over time.
This study is part of a national consortium targeting a sample of at least 5,000 participants. Power calculations, informed by a recent meta-analysis (Li, 2023), indicate that this sample size would yield 93.5% power at a genome-wide significance level (p < 5×10-⁸), assuming a minor allele frequency of 0.2 and an odds ratio of 1.3, accounting for gender, diagnosis, and treatment response variability.
Statistical analyses will be conducted using SPSS software version 29.0. Logistic regression models will be used to examine factors associated with the primary outcomes, and a multivariate regression model will be developed to assess independent associations. All tests will be two-tailed, with statistical significance defined as p < 0.05 and 95% confidence intervals reported.
To identify digital behavioral biomarkers, advanced statistical and machine learning techniques will be applied. Individualized suicide-related profiles will be generated and compared using integrated data from genetic, metabolic, medical, and digital phenotyping sources. Additionally, a personalized and anonymized exposome will be constructed by combining geo-temporal data from Google Takeout with contextual information from public sociodemographic datasets (e.g., INE).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: No Intervention: Observational CohortOur only group consists of people with a lifetime history of suicide attempt |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients with a lifetime history of suicide attempt
Key inclusion criteria (3 listed)
- At least one suicide attempt in their lifetime.
- The attempt must have occurred when the participant was older than 12 years old.
- Participants must be at least 18 years old or have parental consent if aged 12-17.
Key exclusion criteria (2 listed)
- medical contraindication prevents blood sample collection
- unable to provide informed consent to participate in the study
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 |
|---|---|---|
| No Intervention: Observational CohortGenetic analysis | Genetic | Group 1 |
Primary outcome
Suicide attempt
Time frame: Baseline assessment; lifetime suicide attempts occurring from age 12 until enrollment.
Aim to explore associated factors to suicide attempt
2 secondary outcomes
pharmacological treatment efficacy
Time frame: Assessed at baseline; retrospective evaluation of pharmacological treatments received prior to enrollment.
cost-effectiveness of genetic markers
Time frame: Baseline assessment
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 19 Feb 2026.
- Results publication: PubMed 34030748DiBlasi E, Kang J, Docherty AR. Genetic contributions to suicidal thoughts and behaviors. Psychol Med. 2021 Oct;51(13):2148-2155. doi: 10.1017/S0033291721001720. Epub 2021 May 25.
- Results publication: PubMed 38539630Rejek M, Misiak B. The Associations of Exposome Score with Various Domains of Psychopathology: A Network Analysis in a Non-Clinical Sample. Brain Sci. 2024 Feb 29;14(3):242. doi: 10.3390/brainsci14030242.
- Results publication: PubMed 39018056Visoki E, Moore TM, Zhang X, Tran KT, Ly C, Gatavins MM, DiDomenico GE, Brogan L, Fein JA, Warrier V, Guloksuz S, Barzilay R. Classification of Suicide Attempt Risk Using Environmental and Lifestyle Factors in 3 Large Youth Cohorts. JAMA Psychiatry. 2024 Oct 1;81(10):1020-1029. doi: 10.1001/jamapsychiatry.2024.1887.
- Results publication: PubMed 27576363Vineis P, Chadeau-Hyam M, Gmuender H, Gulliver J, Herceg Z, Kleinjans J, Kogevinas M, Kyrtopoulos S, Nieuwenhuijsen M, Phillips DH, Probst-Hensch N, Scalbert A, Vermeulen R, Wild CP; EXPOsOMICS Consortium. The exposome in practice: Design of the EXPOsOMICS project. Int J Hyg Environ Health. 2017 Mar;220(2 Pt A):142-151. doi: 10.1016/j.ijheh.2016.08.001. Epub 2016 Aug 19.
- Results publication: PubMed 39335956Abascal-Peiro S, Penuelas-Calvo I, Alacreu-Crespo A, Saiz PA, De la Torre-Luque A, Ruiz-Veguilla M, Barrigon ML, Courtet P, Lopez-Castroman J, Baca-Garcia E, Porras-Segovia A. Digital Platform for the Prevention of Suicidal Behaviour and Non-Suicidal Self-Injuries in Adolescents: The SmartCrisis-Teen Study Protocol. Behav Sci (Basel). 2024 Aug 25;14(9):740. doi: 10.3390/bs14090740.
- Results publication: PubMed 35276631Porras-Segovia A, Diaz-Olivan I, Barrigon ML, Moreno M, Artes-Rodriguez A, Perez-Rodriguez MM, Baca-Garcia E. Real-world feasibility and acceptability of real-time suicide risk monitoring via smartphones: A 6-month follow-up cohort. J Psychiatr Res. 2022 May;149:145-154. doi: 10.1016/j.jpsychires.2022.02.026. Epub 2022 Mar 3.
- Results publication: PubMed 37656498Barrigon ML, Romero-Medrano L, Moreno-Munoz P, Porras-Segovia A, Lopez-Castroman J, Courtet P, Artes-Rodriguez A, Baca-Garcia E. One-Week Suicide Risk Prediction Using Real-Time Smartphone Monitoring: Prospective Cohort Study. J Med Internet Res. 2023 Sep 1;25:e43719. doi: 10.2196/43719.
- Results publication: PubMed 36805332de la Torre-Luque A, Pemau A, Ayad-Ahmed W, Borges G, Fernandez-Sevillano J, Garrido-Torres N, Garrido-Sanchez L, Garriga M, Gonzalez-Ortega I, Gonzalez-Pinto A, Grande I, Guinovart M, Hernandez-Calle D, Jimenez-Trevino L, Lopez-Sola C, Mediavilla R, Perez-Aranda A, Ruiz-Veguilla M, Seijo-Zazo E, Toll A, Perez-Sola V, Ayuso-Mateos JL; SURVIVE Consortium. Risk of suicide attempt repetition after an index attempt: A systematic review and meta-analysis. Gen Hosp Psychiatry. 2023 Mar-Apr;81:51-56. doi: 10.1016/j.genhosppsych.2023.01.007. Epub 2023 Jan 23.
- Results publication: PubMed 33317338Martinez-Ales G, Cruz Rodriguez JB, Lazaro P, Domingo-Relloso A, Barrigon ML, Angora R, Rodriguez-Vega B, Jimenez-Sola E, Sanchez-Castro P, Roman-Mazuecos E, Villoria L, Ortega AJ, Navio M, Stanley B, Rosenheck R, Baca-Garcia E, Bravo-Ortiz MF. Cost-effectiveness of a Contact Intervention and a Psychotherapeutic Program for Post-discharge Suicide Prevention. Can J Psychiatry. 2021 Aug;66(8):737-746. doi: 10.1177/0706743720980135. Epub 2020 Dec 15.
- Derived from this study: PubMed 42161558Artes C, Porras-Segovia A, Ruiz-Veguilla M, Giner L, Garcia-Campayo J, Lopez Del Hoyo Y, Alejandra-Saiz P, Garcia-Fernandez A, Martinez-Jambrina JJ, Villa-Diez R, Gili M, Roca M, de Andres F, Perez Sola V, Elices ME, Grande I, Cebria AI, Irigoyen-Otinano M, Galvan-Santiago L, Garcia-Iturrospe EJA, Mesones-Peral J, Mora-Marin R, Sierra P, Penas-Lledo E, LLerena A, Lopez-Castroman J, Cruz R, Arrojo M, Ovejero S, de la Torre-Luque A, Palao-Tarrero A, Vaquero-Lorenzo C, Toma C, Barrigon ML, Artes A, Diaz-Marsa M, Ayad-Ahmed W, Ibanez A, Diaz-Sastre C, Salvador-Robert M, Alvarez-Garcia R, Mata-Iturralde L, Benavente-Lopez S, Munoz-Lorenzo L, Di Stasio EF, Carmona-Camacho R, Penuelas-Calvo I, Valencia M, Lopez Pena P, Albarracin-Garcia L, Baca-Garcia E. Designing interventions guided by digital phenotype and pharmacogenetics in Spain for suicidal behaviour based on retrospective data: the multicentre SMARTomicS study protocol. BMJ Open. 2026 May 20;16(5):e106685. doi: 10.1136/bmjopen-2025-106685.
- Global information about suicide, suicide risk, prevention, challenges and statisticsLink provided by the sponsor.
- Spanish National Statistics Institute, with statistic data divided by categoriesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide Attempt, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 3 inclusion and 2 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 19 Feb 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 Spain. 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 Enrique Baca Garcia, Psychiatrist (+34 626932936, ebaca@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide attempt (time frame: Baseline assessment; lifetime suicide attempts occurring from age 12 until enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07422090, which also lists 10 linked publications.
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 19 Feb 2026.