{
  "abstract": "Introduction Each year, suicide claims approximately 700 000 lives worldwide and generates a significant financial burden. Integrating genomic data, exposomic factors and digital phenotypes can enhance the development of short-term predictive models. Current knowledge and available tools provide the basis for designing personalised treatment strategies that incorporate real-time interventions to prevent suicide attempt recurrence cost-effectively. This study aims to develop a predictive algorithm for suicidal behaviour integrating psychiatric assessments, genetic risk markers, digital phenotypes and exposomic data.Methods and analysis This protocol describes a retrospective multicentre study that will recruit participants with a clinical history of suicide across 25 hospitals across Spain with a catchment area of 8.6 million people (17.8% of Spain’s population). Our sample target is over 5000 participants, aged over 12 years old, ensuring 93.5% statistical power for genetic analysis. Eligible participants must be over 12 years old. Data collection will include psychiatric assessments, biospecimen collections (DNA, RNA, plasma and serum), Google Takeout data for digital phenotyping, and a standardised set of administrative and clinical data registered for each patient. Genotyping will be performed with the Axiom Spanish array (>750 000 markers), and genome-wide association studies (GWAS) will be performed after genetic imputation in a whole sample of >10 000 individuals (5000 suicide attempters; 5000 controls). Prescription and clinical history will also be retrospectively integrated, and codified data statistics forms will periodically be sent to the Government. Statistical analyses will combine traditional regression models and AI-based algorithms to identify predictive behavioural, genomic profiles, and digital markers of suicidal behaviour. Cost-effectiveness analyses of pharmacogenomic markers for antidepressant response will also be conducted.By successfully implementing this project, we aim to help reduce suicide reattempts and lessen the emotional and economic burden on families and the healthcare system.Ethics and dissemination This study has been approved by the Ethics Committee of the Fundación Jiménez Díaz (PIC301-24_FJD) and complies with the Declaration of Helsinki. It adheres to the GDPR (EU Regulation 2016/679), Spain’s Organic Law 3/2018 on Personal Data Protection and Digital Rights, and Law 41/2002 on patient autonomy. All required data protection measures will be implemented, including those under Real Decreto 1718/2010 on prescriptions and treatment adherence. Underaged participants will require parental consent for participation. The results will be disseminated through publication in peer-reviewed scientific journals and presentations at psychiatric conferences.Trial registration number NCT07422090.",
  "authors": [
    {
      "affiliations": [
        "Translational Psychiatry Research Group, Instituto de Investigacion Sanitaria de la Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain"
      ],
      "name": "Carmen Artés"
    },
    {
      "affiliations": [
        "Instituto de Investigacion Sanitaria de la Fundacion Jimenez Diaz, Madrid, Spain",
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Department of Psychiatry, Hospital Universitario Rey Juan Carlos, Móstoles, Community of Madrid, Spain"
      ],
      "name": "Alejandro Porras-Segovia"
    },
    {
      "affiliations": [
        "Psychiatry, Hospital Universitario Virgen del Rocio, Sevilla, Spain",
        "Department of Psychiatry, Universidad de Sevilla, Seville, Spain"
      ],
      "name": "Miguel Ruiz-Veguilla"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Universidad de Sevilla, Seville, Spain"
      ],
      "name": "Lucas Giner"
    },
    {
      "affiliations": [
        "Hospital Universitario Miguel Servet, Zaragoza, Aragon, Spain",
        "Universidad de Zaragoza, Zaragoza, Aragon, Spain"
      ],
      "name": "Javier Garcia-Campayo"
    },
    {
      "affiliations": [
        "Universidad de Zaragoza, Zaragoza, Aragon, Spain"
      ],
      "name": "Yolanda López del Hoyo"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Universidad de Oviedo, Oviedo, Asturias, Spain",
        "(ISPA), Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Asturias, Spain",
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "(SESPA), Servicio de Salud del Principado de Asturias, Oviedo, Spain"
      ],
      "name": "Pilar Alejandra-Saiz"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Universidad de Oviedo, Oviedo, Asturias, Spain",
        "Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Asturias, Spain",
        "(INEUROPA), Instituto de Neurociencias del Principado de Asturias, Oviedo, Spain"
      ],
      "name": "Ainoa García-Fernández"
    },
    {
      "affiliations": [
        "Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Asturias, Spain",
        "(INEUROPA), Instituto de Neurociencias del Principado de Asturias, Oviedo, Spain",
        "Hospital San Agustín de Avilés, Aviles, Asturias, Spain",
        "Servicio de Salud del Principado de Asturias, Oviedo, Spain"
      ],
      "name": "Juan José Martínez-Jambrina"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Universidad de Oviedo, Oviedo, Asturias, Spain",
        "(SESPA), Servicio de Salud del Principado de Asturias, Oviedo, Spain",
        "Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo, Asturias, Spain"
      ],
      "name": "Rocío Villa-Díez"
    },
    {
      "affiliations": [
        "Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA), Universitat de les Illes Balears, Palma, Spain"
      ],
      "name": "Margalida Gili"
    },
    {
      "affiliations": [
        "Instituto de Investigación Sanitaria de las Islas Baleares (IDISBA), Universitat de les Illes Balears, Palma, Spain"
      ],
      "name": "Miquel Roca"
    },
    {
      "affiliations": [
        "Departamento de Química Analítica y Tecnología de Alimentos, Facultad de Farmacia, Universidad de Castilla-La Mancha, Ciudad Real, Spain",
        "Instituto Regional de Investigación Científica Aplicada (IRICA), Universidad de Castilla-La Mancha, Ciudad Real, Spain"
      ],
      "name": "Fernando de Andrés"
    },
    {
      "affiliations": [
        "Hospital del Mar, Hospital del Mar Medical Research Institute, Barcelona, Spain",
        "Universitat Pompeu Fabra, Barcelona, Spain"
      ],
      "name": "Víctor Pérez Sola"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Hospital del Mar Medical Research Institute, Barcelona, Spain"
      ],
      "name": "Matilde E Elices"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Bipolar and Depressive Disorders Unit, Hospital Clinic de Barcelona, Barcelona, Spain",
        "Departament de Medicina, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona, Barcelona, Spain",
        "(IDIBAPS), Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain"
      ],
      "name": "Iria Grande"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universitat Autònoma de Barcelona, Barcelona, Spain",
        "Consorci Corporació Sanitària Parc Taulí, Sabadell, Spain"
      ],
      "name": "Ana Isabel Cebria"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Hospital Universitario de Santa María, Lleida, Spain",
        "(IRB Lleida), Institut de Recerca Biomèdica de Lleida Fundació Dr Pifarré, Lleida, Spain"
      ],
      "name": "Maria Irigoyen-Otiñano"
    },
    {
      "affiliations": [
        "(IRB Lleida), Institut de Recerca Biomèdica de Lleida Fundació Dr Pifarré, Lleida, Spain",
        "Departamento de Farmacia, Regio Sanitaria Lleida, Lleida, Spain"
      ],
      "name": "Leonardo Galván-Santiago"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidad de Valencia, Valencia, Valencian Community, Spain",
        "INCLIVA, Hospital Clinico Universitario, Valencia, Valencian Community, Spain"
      ],
      "name": "Eduardo Jesús Aguilar Garcia-Iturrospe"
    },
    {
      "affiliations": [
        "Hospital Universitario de Torrevieja, Torrevieja, Valencian Community, Spain"
      ],
      "name": "Jesús Mesones-Peral"
    },
    {
      "affiliations": [
        "Consorcio Hospitalario Provincial de Castellón, Hospital Provincial Castellón, Castellón de la Plana, Valencian Community, Spain",
        "Universitat Jaume I, Castellón de la Plana, Valencian Community, Spain"
      ],
      "name": "Rafael Mora-Marín"
    },
    {
      "affiliations": [
        "Universidad de Valencia, Valencia, Valencian Community, Spain",
        "Hospital Politécnico y Universitario La Fe, Valencia, Valencian Community, Spain"
      ],
      "name": "Pîlar Sierra"
    },
    {
      "affiliations": [
        "Facultad de Medicina y Ciencias de la Salud, Universidad de Extremadura, Badajoz, Spain",
        "Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain"
      ],
      "name": "Eva Penas-Lledo"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Facultad de Medicina y Ciencias de la Salud, Universidad de Extremadura, Badajoz, Spain",
        "Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain"
      ],
      "name": "Adrian LLerena"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidade de Santiago de Compostela, Santiago de Compostela, Spain",
        "University Hospital Centre Nimes, Nimes, Occitanie, France"
      ],
      "name": "Jorge Lopez-Castroman"
    },
    {
      "affiliations": [
        "Fundación Pública Galega de Medicina Xenómica, Santiago de Compostela, Spain",
        "(CIBERER), Centro de Investigación Biomédica en Red de Enfermedades Raras, Valencia, Valencian Community, Spain"
      ],
      "name": "Raquel Cruz"
    },
    {
      "affiliations": [
        "(SERGAS), Servicio Gallego de Salud, Santiago de Compostela, Spain",
        "Universidad Autónoma de Madrid, Madrid, Community of Madrid, Spain"
      ],
      "name": "Manuel Arrojo"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Universidad Autónoma de Madrid, Madrid, Community of Madrid, Spain"
      ],
      "name": "Santiago Ovejero"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidad Complutense de Madrid, Madrid, Spain"
      ],
      "name": "Alejandro de la Torre-Luque"
    },
    {
      "affiliations": [
        "Universidad Autónoma de Madrid, Madrid, Community of Madrid, Spain",
        "Hospital Universitario La Paz, Madrid, Community of Madrid, Spain"
      ],
      "name": "Ángela Palao-Tarrero"
    },
    {
      "affiliations": [
        "(IUBM-UAM), Instituto de Biología Molecular, Madrid, Community of Madrid, Spain"
      ],
      "name": "Concepción Vaquero-Lorenzo"
    },
    {
      "affiliations": [
        "Universidad Autónoma de Madrid, Madrid, Community of Madrid, Spain",
        "(CBMSO), Centro de Biología Molecular Severo Ochoa, Madrid, Community of Madrid, Spain",
        "(CSIC), Consejo Superior de Investigaciones Cientificas, Madrid, Community of Madrid, Spain",
        "Neuroscience Research Australia, Randwick, New South Wales, Australia"
      ],
      "name": "Claudio Toma"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidad Complutense de Madrid, Madrid, Community of Madrid, Spain",
        "Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Community of Madrid, Spain",
        "(IISGM), Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Community of Madrid, Spain"
      ],
      "name": "Maria Luisa Barrigon"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "(IISGM), Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Community of Madrid, Spain",
        "Department of Signal Theory and Communications, Universidad Carlos III de Madrid, Leganés, Madrid, Spain",
        "Evidence-Based Behavior, Madrid, Community of Madrid, Spain"
      ],
      "name": "Antonio Artes"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidad Complutense de Madrid, Madrid, Community of Madrid, Spain",
        "Hospital Clínico San Carlos, Madrid, Community of Madrid, Spain",
        "Sociedad Española de Psiquiatría y Salud Mental, Madrid, Community of Madrid, Spain"
      ],
      "name": "Marina Díaz-Marsá"
    },
    {
      "affiliations": [
        "Universidad Complutense de Madrid, Madrid, Community of Madrid, Spain"
      ],
      "name": "Wala Ayad-Ahmed"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidad de Alcalá de Henares, Alcala de Henares, Spain",
        "Hospital Universitario Ramón y Cajal, Madrid, Community of Madrid, Spain",
        "(IRYCIS), Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Community of Madrid, Spain"
      ],
      "name": "Ángela Ibáñez"
    },
    {
      "affiliations": [
        "Hospital Universitario Ramón y Cajal, Madrid, Community of Madrid, Spain",
        "(IRYCIS), Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Community of Madrid, Spain"
      ],
      "name": "Carmen Díaz-Sastre"
    },
    {
      "affiliations": [
        "Hospital Universitario de Móstoles, Móstoles, Community of Madrid, Spain",
        "Universidad Rey Juan Carlos, Móstoles, Community of Madrid, Spain"
      ],
      "name": "Mercè Salvador-Robert"
    },
    {
      "affiliations": [
        "Universidad Rey Juan Carlos, Móstoles, Community of Madrid, Spain",
        "Hospital Universitario Rey Juan Carlos, Móstoles, Community of Madrid, Spain"
      ],
      "name": "Raquel Álvarez-García"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain"
      ],
      "name": "Laura Mata-Iturralde"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Hospital Universitario Infanta Elena, Valdemoro, Community of Madrid, Spain"
      ],
      "name": "Sergio Benavente-López"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain"
      ],
      "name": "Laura Muñoz-Lorenzo"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Hospital Universitario General de Villalba, Collado Villalba, Spain"
      ],
      "name": "Ezequiel Fernando Di Stasio"
    },
    {
      "affiliations": [
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Universidad Complutense de Madrid, Madrid, Spain"
      ],
      "name": "Rodrigo Carmona-Camacho"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidad Complutense de Madrid, Madrid, Community of Madrid, Spain",
        "Department of Child and Adolescent Psychiatry, Hospital Universitario 12 de Octubre, Madrid, Community of Madrid, Spain"
      ],
      "name": "Inmaculada Peñuelas-Calvo"
    },
    {
      "affiliations": [
        "IdiSNA, Instituto de Investigacion Sanitaria de Navarra, Pamplona, Navarre, Spain",
        "CIMA Universidad de Navarra, Pamplona, Navarre, Spain"
      ],
      "name": "Miguel Valencia"
    },
    {
      "affiliations": [
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Hospital Universitario Araba, Vitoria-Gasteiz, Spain",
        "Instituto de Investigación Sanitaria Bioaraba, Vitoria-Gasteiz, Spain",
        "Universidad del País Vasco, Leioa, Spain"
      ],
      "name": "Purificación López Peña"
    },
    {
      "affiliations": [
        "Translational Psychiatry Research Group, Instituto de Investigacion Sanitaria de la Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Department of Psychiatry, Hospital Universitario Rey Juan Carlos, Móstoles, Community of Madrid, Spain",
        "Hospital Universitario Infanta Elena, Valdemoro, Community of Madrid, Spain"
      ],
      "name": "Lucía Albarracín-García"
    },
    {
      "affiliations": [
        "Translational Psychiatry Research Group, Instituto de Investigacion Sanitaria de la Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Department of Psychiatry, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Community of Madrid, Spain",
        "Department of Psychiatry, Hospital Universitario Rey Juan Carlos, Móstoles, Community of Madrid, Spain",
        "(CIBERSAM), Carlos III Institute of Health, Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Community of Madrid, Spain",
        "Universidad Autónoma de Madrid, Madrid, Community of Madrid, Spain",
        "Hospital Universitario Infanta Elena, Valdemoro, Community of Madrid, Spain",
        "Department of Psychiatry, Hospital Universitario General de Villalba, Collado Villalba, Spain"
      ],
      "name": "Enrique Baca-Garcia"
    }
  ],
  "title": "Designing interventions guided by digital phenotype and pharmacogenetics in Spain for suicidal behaviour based on retrospective data: the multicentre SMARTomicS study protocol",
  "uid": "163470fa-e14d-52cd-bff1-99619141165d"
}