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NCT07885722Recruiting

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

SMARTomicS: Protocol for a Randomised Controlled Trial Evaluating a Multi-layered Digital Phenotyping and Pharmacogenomic Intervention for Suicide Prevention

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
525 (estimated)
First submitted
24 Sept 2026
Start date
1 Sept 2025
Primary completion date
30 Jun 2027
Lead sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Diseases
Depression
NCT number
NCT07885722

What you commit to

  • Study type: Interventional
  • Planned participants: 525
  • From 1 Sept 2025 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Refusal to install the trial mobile applications (MeMind and eB2 Mindcare)
  • Inability to comprehend or sign the informed consent form

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Fundación Jiménez Díaz, Madrid, Madrid 28040
Coordinator of this site? Confirm its status
MadridSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.