Testing phone monitoring and medication guided by genes in adults with depression
Tests phone monitoring and gene-guided medication care in adults with depression and suicidal thoughts.
Plain-language title generated from the registry record
Registry title: Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Key facts
- Where
- Madrid, SpainSee the site
Where in Spain
- Instituto Fundación Jiménez Díaz, Madrid, Madrid 28040Madrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Trial code
- NCT07885722
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
SMARTomicS: Protocol for a Randomised Controlled Trial Evaluating a Multi-layered Digital Phenotyping and Pharmacogenomic Intervention for Suicide Prevention
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.
Inclusion: 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: Refusal to install the trial mobile applications (MeMind and eB2 Mindcare); Inability to comprehend or sign the informed consent form.