Clinical Trial

Evaluation of Dalia Solution For Depressed Patient

Study acronym: DaliaMonitorin
Not Yet Recruiting
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Record status
This record was last updated October 8, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this superiority clinical investigation, prospective, multicenter, controlled, randomized, open-label is to evaluate the clinical impact of the Dalia medical telemonitoring device on the management of depressive patients. The main question it aims to answer is: the percentage of patients with clinically significant improvement at 3 months. A clinically significant improvement is defined as a decrease of at least 5 points from the initial PHQ-9 score AND/OR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale
Trial Details
NCT Number NCT07211984
Lead Sponsor Dalia Care
Conditions Depression Chronic, Depressed, Depressed Mood, Depression and Quality of Life, Depression Diagnosis
Enrollment 644 participants
Start Date 2025-10-10
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-08