Multi-layered digital monitoring and pharmacogenomics to prevent suicide in adults with depression
Official title: SMARTomicS: Protocol for a Randomised Controlled Trial Evaluating a Multi-layered Digital Phenotyping and Pharmacogenomic Intervention for Suicide Prevention
Run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT07885722 · Data updated 2026-11-12
This study tests whether a digital monitoring system, a digital safety plan, and pharmacogenetic-guided care can reduce suicide re-attempts in adults with depression.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 525 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07885722 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ with a recent suicide attempt, PHQ-9 ≥ 15, internet-enabled smartphone, and willingness to provide genetic and pharmacokinetic samples.
✕Probably not a fit
Individuals without access to compatible smartphones or who decline genetic testing may not experience the potential benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, 6-month, three-arm randomized trial in Spain evaluating digital phenotyping, an interactive digital safety plan, and pharmacogenomic-guided therapy with therapeutic drug monitoring. Participants are adults with documented prior suicide attempt and moderate-to-severe depression, randomized to: (1) standard care plus digital phenotyping, (2) standard care plus digital phenotyping and an interactive safety plan, (3) standard care plus digital phenotyping, safety plan, and pharmacogenetic-guided care. The trial uses active and passive smartphone-based ecological momentary assessment and monitoring, with pharmacogenomic and drug-monitoring results masked until Week 24. The primary aim is to see if the multi-layered intervention lowers suicide attempts over 6 months and to evaluate effects on depressive symptoms and treatment-emergent adverse effects.
Why it matters
Potential benefit: If successful, patients could experience fewer suicide attempts and improved depressive symptoms through personalized, data-driven care.
How similar studies have gone: Previous digital health approaches for mood disorders show promise, but this specific combination of EMI, DSP, and pharmacogenomics is exploratory in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Instituto Fundación Jiménez Díaz, Madrid, Madrid 28040
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Enrique Baca Garcia, Psychiatrist
- Email: ebaca@fjd.es
- Phone: +34 626932936
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.