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Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression

RecruitingNAAges 18 Years - anyAllInstituto de Investigación Sanitaria de la Fundac…
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In plain words

What the trial is, and whether it could suit you

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 safe

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older * Documented history of a suicide attempt within the preceding 2 years * Current treatable depression indicated by a Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater * Active possession of an internet-connected smartphone (iOS or Android) with basic digital literacy * Capacity to provide written informed consent * Willingness to provide blood samples for genetic, multi-omics, and pharmacokinetic profiling Exclusion Criteria: * Refusal to install the trial mobile applications (MeMind and eB2 Mindcare) * Inability to comprehend or sign the informed consent form
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What it tests

  • Digital Monitoring (Active/Passive EMA)
  • Ecological Momentary Intervention (EMI) via Digital Safety Plan
  • Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring
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Where

1 site
Instituto Fundación Jiménez Díaz, Madrid, Madrid 28040
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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