Preventing Suicide With Digital Phenotyping and Pharmacogenetics-Based Interventions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

medical contraindication prevents blood sample collection

unable to provide informed consent to participate in the study

Trial design

Treatments tested in this trial

  • No Intervention: Observational Cohort

Treatment groups

5,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz-ISCIII

Collaborator

Hospital Universitario Fundación Jiménez Díaz

Collaborator

Hospital Universitario Rey Juan Carlos

Collaborator

Hospitales Universitarios Virgen del Rocío

Collaborator

University of Seville

Collaborator

Universidad de Zaragoza

Collaborator

Universidad de Oviedo

Collaborator

Instituto de Investigación Sanitaria del Principado de Asturias - ISPA

Collaborator

Centro de Investigación Biomédica en Red de Salud Mental

Collaborator

Hospital Miguel Servet

Collaborator

Servicio de Salud del Principado de Asturias. Área Sanitaria III

Collaborator

Fundació d'investigació Sanitària de les Illes Balears

Collaborator

University of Castilla-La Mancha

Collaborator

Hospital del Mar Research Institute (IMIM)

Collaborator

Hospital de Aviles

Collaborator

Universitat Pompeu Fabra

Collaborator

University of Barcelona

Collaborator

Hospital Clinic of Barcelona

Collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain.

Collaborator

Corporacion Parc Tauli

Collaborator

Universitat Autonoma de Barcelona

Collaborator

Institut de Recerca Biomèdica de Lleida

Collaborator

Hospital Clínico Universitario de Valencia

Collaborator

University of Valencia

Collaborator

Hospital Universitario La Fe

Collaborator

Hospital Provincial de Castellon

Collaborator

Universidad de Extremadura

Collaborator

University of Santiago de Compostela

Collaborator

Centre Hospitalier Universitaire de Nīmes

Collaborator

Centro de Investigación en Red de Enfermedades Raras (CIBERER)

Collaborator

Servicio Gallego de Salud

Collaborator

Universidad Autonoma de Madrid

Collaborator

Universidad Complutense de Madrid

Collaborator

Hospital Universitario La Paz

Collaborator

Centro de Biología Molecular Severo Ochoa, Spain (CBMSO)

Collaborator

Fundación General CSIC

Collaborator

Neuroscience Research Australia

Collaborator

The University of New South Wales

Collaborator

Hospital General Universitario Gregorio Marañon

Collaborator

Instituto de Investigación Sanitaria Gregorio Marañón

Collaborator

Universidad Carlos III de Madrid

Collaborator

Hospital San Carlos, Madrid

Collaborator

Hospital Universitario Ramon y Cajal

Collaborator

University of Alcala

Collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborator

Hospital Universitario de Móstoles

Collaborator

Universidad Rey Juan Carlos

Collaborator

Hospital Universitario Infanta Elena

Collaborator

Hospital Universitario 12 de Octubre

Collaborator

Fundación Instituto de Investigación Sanitaria de Navarra

Collaborator

Centro de Investigación Médica Aplicada (CIMA)

Collaborator

Hospital Universitario Araba

Collaborator

Bioaraba Health Research Institute

Collaborator

Euskal Herriko Universitatea - Universidad del País Vasco. Qualiker.

Collaborator

Universidad Católica del Maule

Collaborator