NCT07885722 Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
| NCT ID | NCT07885722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| Condition | Depressive Disorder, Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 525 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 525 participants in total. It began in 2025-09-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07885722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive Disorder, Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07885722 currently recruiting?
Yes, NCT07885722 is actively recruiting participants. Contact the research team at ebaca@fjd.es for enrollment information.
Where is the NCT07885722 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07885722 clinical trial?
NCT07885722 is sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. The trial plans to enroll 525 participants.