Evaluation of Dalia Solution For Depressed Patient

NCT07211984 | Not Yet Recruiting

• 1 other identifier: 2025-A01266-43
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Depression Chronic; Depressed; Depressed Mood; Depression and Quality of Life; Depression Diagnosis

Keywords

Depression; PHQ-9; MADRS; Depressive episode; Anxiety disorder; Antidepressant prescriptions; Smartwatch

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary endpoint will be 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

  12 months after inclusion

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients assigned to the "control" group will follow conventional healthcare. According to french "Haute Autorité de Santé", conventional management includes advice on adopting a healthy lifestyle, psychotherapy with a contracted psychologist, and the prescription of antidepressants if necessary. In this case, regular medical follow-up by the general practitioner or psychiatrist is recommended, particularly at the start of antidepressant treatment (notably after the first and second week). Follow-up consultations to assess treatment response should be performed by the physician between M1 and M2, then at M3, M6, and M12, with a frequency adapted according to the clinical evolution of the patient

Other: Conventional healthcare

Interventional Arm

EXPERIMENTAL

Patients assigned to the "intervention" group will benefit from Dalia telemonitoring in addition to conventional management.

Device: Dalia Monitoring

Interventions

Dalia Monitoring DEVICE

All patients consulting psychiatrists and general practitioners in participating centers, meeting all eligibility criteria and agreeing to participate in the study, will be consecutively selected and randomized into one of the two groups. For iInterventional arm: Patients will benefit from Dalia telemonitoring, in addition to conventional care.

Interventional Arm

Conventional healthcare OTHER

All patients consulting psychiatrists and general practitioners in participating centers, meeting all eligibility criteria and agreeing to participate in the study, will be consecutively selected and randomized into one of the two groups. For Control arm: Patients in this group will benefit from the conventional care pathway.

Control Group

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient with a diagnosis of depressive episode, as defined by ICD-11, and with a PHQ-9 score ≥ 15 confirmed by a psychiatrist or general practitioner
• Patient equipped with a smartphone or a computer or a tablet with internet access
• Patient affiliated to a health insurance scheme
• Patient able to read and understand French
• Patient having signed informed consent

You may not qualify if:

• Patient under non-cardioselective beta-blocker (carvedilol, labetalol, propranolol, pindolol) and beta-mimetic (salbutamol, terbutaline)
• Patient with a pacemaker or with a known cardiac arrhythmia
• Patient with major neurocognitive disorder (e.g., dementia) or psychotic disorders likely to compromise participation in the study
• Patient treated with esketamine
• Patient with excessive consumption of psychoactive substances (alcohol or drugs), which may interfere with the course or follow-up of the study
• Patient unable to wear the bracelet during the study due to dermatological conditions
• Patient under guardianship, curatorship, or legal protection, or any other administrative or judicial measure depriving rights and freedom
• Patient considered non-autonomous by the investigator
• Patient already included in another interventional research study
• Vulnerable persons referred to in Articles L.1121-5 to 8 and L.1122-1-2 of the French Public Health Code are excluded from the study

Sponsors & Collaborators

• Dalia Care: lead

Study Sites (1)

Neurostim Luxembourg

Paris, 75005, France

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Consciousness Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Stéphane Mouchabac, Doctor

  Dalia Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nour Hakiki Belhadi

CONTACT

+33758082693; nour@daliacare.com

Alexis Bourla

CONTACT

+33 1 87 66 87 44; contact@neurostimfrance.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: October 10, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

FR (1)