Preventing Suicide With Digital Phenotyping and Pharmacogenetics-Based Interventions

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. Can behavioral factors associated with suicide risk be explored through data obtained from Google Takeout? 2. Is there an association between medication changes and suicidal behavior, as identified through the Unified Prescription Module and the Digital Health Record? 3. Do different suicidal phenotypes differ based on the collected variables? 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? The investigators hypothesize that: 1. Individuals with a history of suicidal behavior will show significant genotypic differences compared to the general population (based on Spanish Genome Project data). 2. 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

NCT Number	NCT07422090
Lead Sponsor	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Collaborators: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz-ISCIII, 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, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain., 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
Conditions	Suicide Attempt
Enrollment	5,000 participants
Start Date	2025-04-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-19