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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 16, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07878754). This is a study registration, not published results. Lead sponsor: ThIA Santé Mentale. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 608 participants (ESTIMATED). Conditions: Depression Chronic, Depression and Quality of Life, Depression, Major Depressive Episode. Interventions: DEVICE: Use of ThIA Medical Device. Primary outcome measures: Number of Participants with A Reduction of 5 Points in PHQ-9 Score , From enrollment to 6 months after. Brief summary: The goal of this clinical trial is to learn if ThIA Suivi, a digital tool for remote monitoring of patients, can improve the care of adults with depression who are followed by a psychiatrist. The main question it aims to answer is: \* Does using ThIA Suivi in addition to usual psychiatric care increase the proportion of patients whose depression symptoms have clearly improved after 3 months, compared with usual care alone? (Improvement is measured with a questionnaire on depression symptoms, the PHQ-9, and is defined as a drop of at least 5 points from the starting score.) Researchers will compare patients who use ThIA Suivi with patients who receive usual care only, to see if ThIA Suivi leads to a greater improvement in symptoms. The researchers' hypothesis is that patients using ThIA Suivi will do better. \[ Participants will: * Continue to be followed by their psychiatrist as usual. * Use ThIA Suivi or will receive usual care only * Complete questionnaires about their symptoms at 3 months, 6 months and 12 months. * Be followed for 12 months. Why is this study needed? Depression is a common mental health condition. It causes lasting sadness, loss of interest in everyday activities, and low energy. About 280 million people worldwide live with depression. It affects daily life, work, and relationships, and it can come back: more than half of people who have one episode will have another. Depression is often treated with antidepressant medication. However, after 8 weeks of treatment, only about 1 in 3 people fully recovers. Side effects can appear before the benefits, which can make it hard to keep taking the medication. Close follow-up after treatment starts is therefore important. In practice, the first follow-up visit often happens late (a median of 27 days after the prescription in France). In addition, psychiatrists are not evenly spread across France, and most first antidepressant prescriptions are written by general practitioners. Digital tools may help patients and health professionals stay in contact between visits. In France, however, no remote monitoring tool for mental health is currently reimbursed by the national health insurance. ThIA Suivi was developed by ThIA Santé Mentale to fill this gap. It is meant to be used within a care pathway supervised by health professionals. The researchers hope that it will improve patients' care, help them stay on track with treatment, and reduce the risk of the depression coming back.