NCT07422090

Brief 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. 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:

  1. 1.Can behavioral factors associated with suicide risk be explored through data obtained from Google Takeout?
  2. 2.Is there an association between medication changes and suicidal behavior, as identified through the Unified Prescription Module and the Digital Health Record?
  3. 3.Do different suicidal phenotypes differ based on the collected variables?
  4. 4.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?
  5. 5.Individuals with a history of suicidal behavior will show significant genotypic differences compared to the general population (based on Spanish Genome Project data).
  6. 6.Suicidal phenotypes-especially between single and multiple attempters-will differ across collected variables, including genotype, omics, and exposome data.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Apr 2025Jan 2028

Study Start

First participant enrolled

April 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

November 17, 2025

Last Update Submit

February 18, 2026

Conditions

Suicide Attempt

Keywords

suicidesuicide attemptsuicidal ideationphenotypingdigital medicineeHealthgeneticexposome

Outcome Measures

Primary Outcomes (1)

  • Suicide attempt

    Aim to explore associated factors to suicide attempt

    Baseline assessment; lifetime suicide attempts occurring from age 12 until enrollment.

Secondary Outcomes (2)

  • pharmacological treatment efficacy

    Assessed at baseline; retrospective evaluation of pharmacological treatments received prior to enrollment.

  • cost-effectiveness of genetic markers

    Baseline assessment

Study Arms (1)

Group 1

Our only group consists of people with a lifetime history of suicide attempt

Genetic: No Intervention: Observational Cohort

Interventions

No Intervention: Observational CohortGENETIC

Genetic analysis

Group 1

Eligibility Criteria

Age12 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients with a lifetime history of suicide attempt

You may qualify if:

  • 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.

You may not qualify if:

  • medical contraindication prevents blood sample collection
  • unable to provide informed consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (9)

  • 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.

    PMID: 34030748RESULT

  • Rejek 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.

    PMID: 38539630RESULT

  • Visoki 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.

    PMID: 39018056RESULT

  • Vineis 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.

    PMID: 27576363RESULT

  • Abascal-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.

    PMID: 39335956RESULT

  • Porras-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.

    PMID: 35276631RESULT

  • Barrigon 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.

    PMID: 37656498RESULT

  • de 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.

    PMID: 36805332RESULT

  • Martinez-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.

    PMID: 33317338RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Suicide, AttemptedSuicideSuicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Central Study Contacts

Enrique Baca Garcia, Psychiatrist

CONTACT

+34 626932936ebaca@fjd.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

February 19, 2026

Study Start

April 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)