Trial · NCT07885722
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
NCT07885722, Not applicable, Recruiting, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression. Trials, record NCT07885722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07885722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
- NCT number
- NCT07885722
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 525 participants, estimated
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Conditions
- Depressive Disorder, Major Depressive Disorder, Suicidal Ideation, Suicide, Attempted, Suicide Prevention
- Interventions
- Digital Monitoring (Active/Passive EMA), Ecological Momentary Intervention (EMI) via Digital Safety Plan, Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Incidence Rate of Prospective Non-Fatal Suicide Re-Attempts | 24 weeks post-randomisation | The proportion of participants experiencing one or more prospective non-fatal suicide re-attempts over the follow-up period. Event occurrences are ascertained through a combined audit of participants' electronic health records (EHR) and regional emergency department census databases to ensure comprehensive event capture. |
| Secondary | Change from Baseline in Depressive Symptom Severity as Measured by the Patient Health Questionnaire-9 (PHQ-9) | Baseline, Week 4, Week 8, Week 12, and Week 24 | Evaluates changes in depressive symptom severity using the PHQ-9 scale, where scores range from 0 to 27, with higher scores indicating greater depression severity. Treatment response is defined as a reduction of 50% or more, and remission as a score of 4 or less. |
| Secondary | Change from Baseline in Suicidal Ideation Severity Score on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Week 4, Week 8, Week 12, and Week 24 | Change in suicidal ideation severity assessed using the C-SSRS clinician-rated scale. The scale evaluates ideation intensity on a ordinal severity subscale ranging from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). |
| Secondary | Incidence and Severity of Treatment-Emergent Adverse Drug Reactions (ADRs) | 24 weeks post-randomisation | Proportion of participants experiencing one or more treatment-emergent adverse drug reactions (ADRs), recorded via clinician electronic Case Report Form (eCRF) logs, structured patient-reported questionnaires, and standardized nursing UKU Side Effect Rating Scale assessments. |
| Secondary | Incremental Cost-Effectiveness Ratio (ICER) Per Averted Suicide Attempt | 24 weeks post-randomisation | Health economic evaluation computing the ICER per averted suicide attempt from healthcare system and societal perspectives. Integrates direct medical/non-medical costs and indirect productivity losses using a decision-tree model. |
| Secondary | Number of Suicide-Related Emergency Department Visits Per Participant | 24 weeks post-randomisation | Total count of emergency department visits specifically attributable to suicidal behavior or acute suicidal crisis per participant, extracted directly from electronic health records. |
| Secondary | Number of All-Cause Emergency Department Visits Per Participan | 24 weeks post-randomisation | Total count of all-cause emergency department visits per participant, extracted directly from electronic health records. |
| Secondary | Number of Psychiatric Hospital Admissions Per Participant | 24 weeks post-randomisation | Total count of inpatient psychiatric hospital admissions per participant, extracted directly from electronic health records. |
| Secondary | Total Length of Inpatient Psychiatric Stay | 24 weeks post-randomisation | Total cumulative number of days spent as an inpatient in a psychiatric hospital setting per participant, extracted directly from electronic health records. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07885722
GET https://conductscience.org/api/trials/v1/NCT07885722/registered