A Phase 1 interventional study of Use of ThIA Medical Device in Depression Chronic, Depression and Quality of Life and Depression, sponsored by ThIA Santé Mentale. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by ThIA Santé Mentale · Phase 1, Interventional, and Treatment
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:
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.
Depression is a mental health disorder characterized by persistent sadness, loss of interest in previously enjoyed activities, and a marked decrease in energy. It can present in different forms, including depressed mood, depressive syndrome, or major depressive episode (MDE), which is the best-defined form in international medical classifications. The diagnosis of a Major Depressive Episode (MDE) relies mainly on clinical assessment. However, standardized tools such as the Patient Health Questionnaire-9 (PHQ-9), the Montgomery-Åsberg Depression Rating Scale (MADRS), the Beck Depression Inventory-II (BDI-II), the Hospital Anxiety and Depression Scale (HADS), and the Hamilton Depression Rating Scale (HDRS) are also used. These tools were designed and validated to support and guide diagnosis, in both clinical and research settings. They make it possible to measure symptom severity and to monitor it over time. MDE is defined by several factors, including core symptoms (e.g., depressed or irritable mood, loss of interest), negative thoughts, and severity and duration criteria (a minimum number of symptoms present during the past 15 days).
Worldwide, approximately 3.8% of the population (280 million people) suffers from depression. The prevalence is 5% among adults (4% of men and 6% of women) and 5.7% among people over 60 years of age. In France, an estimated 15 to 20% of the general population is affected by MDE, with a prevalence of 12.5% among 18- to 85-year-olds in 2021. Several severity grades of MDE are distinguished; moderate to severe levels are estimated to account for 95% of all cases, regardless of sex. However, depression is more frequent in women (11.4% versus 5.3% in men).
A first MDE may sometimes resolve within six to nine months without specific intervention, but pharmacological treatment is often recommended for moderate to severe cases.
After eight weeks of treatment, about one third of patients achieve complete remission, another third achieve partial remission, and the last third do not respond to treatment.
Because of its individual and societal consequences, depression is a major public health problem, generating high costs related to absenteeism as well as to the overall care of affected individuals. Indeed, depression impairs the daily functioning and the social and professional relationships of those affected, and is associated with very frequent suicidal behaviors in these individuals. At the societal level, the direct and indirect costs associated with depression-related absenteeism were estimated at US$210 billion in the United States in 2010. In France, mental health is now a priority, with health insurance spending exceeding €23 billion in 2023. Including indirect costs, total spending related to psychiatric illness could exceed €163 billion, with depressive and anxiety disorders among the leading causes of years lived with disability.
Depression is a disorder marked by recurrence, with the risk of depressive episodes increasing after each episode. This risk is mainly predicted by the number of previous episodes: more than 50% of individuals develop a second episode after the first. After two episodes, this rate rises to 70%, and it reaches 90% after three episodes. The management of depression is multidisciplinary and varies according to the severity of the disorder. Pharmacological treatment is generally recommended for moderate to severe cases. Initial antidepressant treatment lasts 6 to 12 weeks. The French National Authority for Health (Haute Autorité de Santé, HAS) recommends assessing treatment efficacy between 4 and 8 weeks before starting a second, continuation phase of 4 to 9 months. During this second phase, the treatment may be adjusted or changed depending on the patient's progress.
It is not uncommon for the potential adverse effects of prescribed antidepressants to be observed before the benefits of treatment, which must be anticipated and clearly explained to the patient to promote adherence to therapy. Indeed, compliance with treatment recommendations for depression significantly reduces the risk of relapse, highlighting the importance of adherence to pharmacological treatments. Adequate adherence to therapeutic guidelines is crucial to improve clinical outcomes and achieve remission of symptoms. The literature indicates that adherence rates are generally low and tend to decline over time, which is associated with an increased risk of relapse and higher healthcare costs.
In France, geographic disparities in the distribution of psychiatrists, with a strong concentration in Île-de-France compared with other regions, limit access to care for patients requiring their expertise. General practitioners have become the main recourse for patients with mental disorders or psychological distress. Indeed, an estimated 15 to 40% of general practitioners' active patient lists present with a mental disorder or psychological distress. However, although trained in the management of somatic conditions, general practitioners sometimes lack the specific skills to recognize, support, and treat psychiatric disorders in depth. This often results in limited management and heavy prescription of psychotropic drugs. An estimated 90% of first-line antidepressant prescriptions come from general practitioners, yet follow-up remains insufficient. For example, the first medical follow-up after a prescription often occurs late, with a median of 27 days, whereas it is crucial for assessing efficacy, tolerability, adherence, and suicide risk. Since March 1960, France has had a sector-based psychiatric policy aimed at guaranteeing a minimum level of territorial provision, with a relatively dense geographic distribution. However, this system appears to have reached its limits, and digital solutions now represent an innovative lever to address this major public health issue. Digital mental health tools offer technological and practical means to overcome barriers related to access to care, specialized diagnosis, and personalized management. Digital phenotyping of patients is essential to move psychiatric care toward a precision medicine approach.
In the literature, digital solutions such as mobile applications have demonstrated effectiveness in improving mental well-being and reducing symptoms of depression and anxiety. Indeed, several systematic reviews and meta-analyses have reported the efficacy of app-based mHealth interventions for managing anxiety and depression symptoms, with small to moderate effects compared with control groups. Although studies support the effectiveness of mobile applications in managing mental disorders, most focus on stand-alone digital therapies, without fully integrating care coordination. Yet by facilitating information exchange between patients and healthcare professionals, these telemonitoring tools can help provide and improve access to personalized care. The recent health crisis has fostered the emergence of innovative digital health approaches, highlighting the importance of the digital transformation of care pathways. It has shown that this transformation could improve coordination among healthcare professionals and overcome traditional barriers to access to care, such as geographic distance. In mental health, quality follow-up and good coordination among healthcare professionals are essential to ensure optimal patient management. Telemonitoring could play a key role by facilitating this coordination and patient follow-up through alerts adapted to each patient's situation. These qualified data, integrated through dedicated solutions, make it possible to adjust each patient's specific care in real time according to the needs and circumstances that triggered the alert. However, in France, there is currently no telemonitoring device in mental health reimbursed by the French National Health Insurance (Assurance Maladie). Currently available digital solutions, such as Doctolib, Maiia, Weda, or Qare, are limited to practice-management tools designed to facilitate consultations for practitioners, without any innovation aimed at improving the quality of care. Likewise, existing self-monitoring or psychological support solutions, such as MonSherpa and Jardin Mental, as well as the psychological support services offered by supplementary health insurers such as Alan or Teale, do not have an integrated telemonitoring system dedicated to psychiatry. With its innovative solution ThIA Suivi, ThIA Santé Mentale aims to fill this gap by offering the first digital telemonitoring device specifically dedicated to mental health, fully integrated into a care pathway supervised by healthcare professionals. In addition to its potential medico-economic impact, this device is part of a sustainable-care approach, aiming to optimize patient management while reducing the risk of relapse. This clinical investigation therefore aims to evaluate the clinical efficacy of ThIA Suivi in the management of depressed patients followed by a psychiatrist.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 608 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with ThIA Santé Mentale as lead sponsor.
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Exclusion Criteria:
Control group: patients receiving standard care in accordance with their usual follow-up and treatment (regular in-person visits with their psychiatrist, etc.)
Patients enrolled in the care pathway managed by the ThIA Suivi remote medical monitoring system. Randomization for this study will be electronic and centralized, with stratification based on the psychiatrist's practice setting (community mental health center or private practice). Patients recruited by the psychiatrist will be randomly and evenly assigned, in a 1:1 ratio, to either the experimental group or the control group. Patients participating in this clinical trial must use the system at the expected frequency in order to complete all clinical questionnaires after starting treatment or after a change in their treatment regimen.
Device: Use of ThIA Medical Device
As soon as the patient has provided free and informed consent, signed it, he or she will be randomized and assigned to one of the two study arms: standard care combined with ThIA Suivi remote medical monitoring, or standard care alone. Regardless of which randomization arm he or she is assigned to, the patient will receive optimal care. The patient in this arm will have access to the "ThIA Suivi" remote medical monitoring system starting the days following their medical consultation with the psychiatrist and throughout his/her participation in the study, in addition to his/her usual standard of care. The patient will have access to all the features of the ThIA Suivi app, including personalized therapeutic education, standardized questionnaires to assess mental health, an alert and notification system, as well as monitoring of side effects and treatment adherence. This system will enable real-time monitoring of symptom progression, allowing the psychiatrist to intervene quickly.
Number of Participants with A Reduction of 5 Points in PHQ-9 Score
To evaluate the clinical impact of the ThIA Suivi remote medical monitoring system in the care of patients with depression, compared with standard of care, the primary outcome measure is the proportion of patients who responded to treatment at 3 months. Response to treatment is defined by the presence of: a significant improvement, defined as a reduction of at least 5 points in the PHQ-9 score compared to the baseline score. The 5-point threshold corresponds to the Minimal Clinically Important Difference (MCID).
Time frame: From enrollment to 6 months after
Number of Participants With a PHQ-9 Score < 15 and Having A New Polology or a Reduction of Antidepressants
To evaluate the clinical impact of ThIA Solution, the study will calculate : * Proportion of patients who reduced their baseline score by at least 5 points at M6 and M12; * Proportion of patients with a PHQ-9 score \< 15 at M3, M6, and M12; * Proportion of patients who reduced their baseline PHQ-9 score by at least 50% at M3, M6, and M12; * Proportion of patients who had a change in their initial dosage at M3, M6, and M12; * Proportion of patients who switched from their initial antidepressant at M3, M6, and M12.
Time frame: At 3 Months, 6 Months and 12 Months after the recruitment
Number of Participants Within a Remission Process
To evaluate the Device's Impact on the Remission of Participants, the study will calculate: * Proportion of patients in remission (PHQ-9 \<5) at M3, M6, and M12 * Proportion of patients in remission at M3 who remained in remission at M6 and M12 * Proportion of patients in remission at M6 who remained in remission at M12
Time frame: At 3 Months, 6 Months and 12 Months after the recruitment
Number of Participants With Adherence to Treatment
To evaluate the clinical impact of the Device on the antidepressant treatment, we will calculate: * Proportion of patients who reported starting their treatment within 0-3, 4-7, and more than 7 days after prescription. * Proportion of patients who reported at M3, M6 and M12 that they were following their psychiatrist's prescriptions, including the dosage of antidepressants. * Proportion of patients reporting side effects related to the antidepressant treatment received at M3, M6 and M12 * Proportion of patients adhering to the antidepressant treatment received at M3, M6 and M12 (Morisky MMAS-4 scale)
Time frame: At 3 Months, 6 Months and 12 Months after the recruitment
Number of Participants With Major Amelioration of Well-being
To evaluate the Impact of the ThIA Suivi Medical Device on other indicateurs and well-being measures, we will assess: * Changes in the quality of life index (EQ-5D-5L) at M3, M6 and M12, compared with the baseline value (M0). * Proportion of patients who self-reported suicidal behaviour (item 9 of the PHQ) at M0, M3, M6 and M12. * Proportion of patients with sleep disorders (Epworth Sleepiness Scale) at M0, M3, M6 and M12 * Proportion of patients taking anxiolytics at M0, M3, M6 and M12 * Change in the mean anxiety score (GAD-7 questionnaire) at M3, M6 and M12, compared with M0. * Change in the mean BMI score at M3, M6 and M12, relative to M0. * Proportion of patients on sick leave due to depression at T0 * Mean duration between the start date of the most recent period of sick leave due to depression and the date of inclusion (only among patients on sick leave at T0). * Proportion of patients who had at least one period of sick leave and duration of sick leave (M0, M3, M6, M12)
Time frame: From the recruitment to 12 Months
Number of Non-Scheduled Procedures
To evaluate the organisational and medico-economic impact of ThIA Suivi Medical Device: * Number of visits to A\&E related to depression, at M3, M6 and M12 * Number of unscheduled consultations related to depression (with a GP or psychiatrist), at M3, M6 and M12 * Number of unscheduled hospital admissions related to depression or side effects of antidepressant treatment at 3 months, 6 months and 12 months * Proportion of patients reporting at least one hospital admission due to depression or side effects related to the treatment received, at M3, M6 and M12 * Total cost of care: the sum of all expenses and costs (consultations, treatments, hospital admissions, digital interventions, etc.) incurred to provide comprehensive care for a patient during the study. * Incremental cost per responding patient: the difference in total cost of care between the device under investigation and standard care, relative to the number of patients considered to have responded to treatment.
Time frame: At 3 Months, 6 Months and 12 Months after the recruitment
Number of Alerts Within the Medical Device
Measurement of operational performance indicators (volume of activity, efficiency, responsiveness, and quality/collaboration) for the network associated with the roll-out of the ThIA Suivi remote medical monitoring system: * Average number of alerts received per day and per month; * Proportion of alerts resolved by the end of the study; * Average time taken to resolve alerts received by the end of the study; * Time, measured in hours, between the alert being raised and its final closure following intervention by a healthcare professional.
Time frame: At the end of the study
Evaluation of Adherence to ThIA Suivi Telemonitoring
To evaluate the adherence of ThIA Suivi Telemonitoring, the study will: For mandatory questionnaires at M3, M6 and M1 * Average completion rate per patient calculated for each patient and then for all patients in the experimental group. * Completion rate by questionnaire type: the ratio of the total number of completed questionnaires to the total expected number, calculated individually and then for all patients in the experimental group. * Distribution of compliance levels: proportion of patients who completed \< 25 per cent, 25 per cent to 50 per cent, 50 per cent to 75 per cent and ≥ 75 per cent of the expected questionnaires, calculated overall and by questionnaire type. Scheduled (automatic) dispatch of the PRISE, FIBSER and MMAS-4 questionnaires. \- Completion rate for each type of questionnaire sent (PRISE, FIBSER, MMAS-4). The completion rate will be defined as the ratio of the total number of completed questionnaires to the total number of questionnaires.
Time frame: At the end of the study
Satisfaction and acceptance rate of ThIA Suivi Telemonitoring
To evaluate the acceptability and the satisfaction rate of Participants, the study will analyze: * Average weekly usage time of the app per patient * Spontaneous usage rate (for the PRISE and FIBSER tolerance questionnaires only) * Proportion of patients who initiated a PRISE (or FIBSER) questionnaire at least once on their own initiative at M3, M6 and M12. * Average number of questionnaires (PRISE and FIBSER) initiated per patient at M3, M6 and M12. * Average usability score for the device, as assessed by patients and healthcare professionals (French version of the SUS questionnaire - System Usability Scale) at the end of the study * Levels of satisfaction with the device among patients and healthcare professionals, assessed using a specific questionnaire to be completed at the end of the study
Time frame: At the end of the study
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Sep 2027, 17 months after the start.
Of 33 industry-sponsored phase 1 interventional studies under Depression, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 17. This study's planned 17 months is above that.
Counting every sponsor, half of 121 studies reached it within 20 months; a quarter within 8 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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