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Life sciences · Interventional Study
ClinicalTrials.gov · October 21, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07885722). This is a study registration, not published results. Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 525 participants (ESTIMATED). Conditions: Depressive Disorder, Major Depressive Disorder, Suicidal Ideation, Suicide, Attempted, Suicide Prevention. Interventions: OTHER: Digital Monitoring (Active/Passive EMA); BEHAVIORAL: Ecological Momentary Intervention (EMI) via Digital Safety Plan; GENETIC: Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring. Primary outcome measures: Cumulative Incidence Rate of Prospective Non-Fatal Suicide Re-Attempts , 24 weeks post-randomisation. Brief summary: The goal of this clinical trial is to learn if a multi-layered digital and pharmacogenomic intervention works to prevent suicide re-attempts in adults with depression. It will also evaluate the safety and effectiveness of continuous digital monitoring, digital safety plans, and precision medication management. The main questions it aims to answer are: * Does the multi-layered intervention lower the rate of suicide re-attempts over a 6-month period compared to standard care? * How do digital tools and genetic-guided prescribing affect depressive symptom severity and treatment-emergent adverse drug reactions? Researchers will compare three groups: participants receiving standard care plus digital monitoring, participants receiving standard care plus digital monitoring and an interactive digital safety plan, and participants receiving standard care plus digital monitoring, a digital safety plan, and pharmacogenetic-guided care. Participants will: * Install study smartphone applications (MeMind and eB2 Mindcare) to track daily mood, stress, and activity patterns through active and passive digital phenotyping. * Authorize historical digital trace extraction via Google Takeout and provide baseline blood samples for genetic, multi-omics, and pharmacokinetic profiling. * Complete regular clinical checkups and questionnaire assessments at baseline and at weeks 4, 8, 12, and 24.