Relevance of a Telemedicine Monitoring in the Management of Depression

NCT06076317 | Recruiting

• 2 other identifiers: APHP2109902023-A00119-36
• Study Type: interventional
• Target: 836
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is a common chronic disease. It is the main cause of morbidity and disability in the world with, among other things, an increase in cardio-metabolic risk and a reduction in life expectancy, regardless of suicide risk. MDD is the most expensive medical condition: 10-20 billion €/year in France. This cost is mainly attributable to the functional consequences of the disease, highlighting the medico-economic challenge represented by the optimization of the organization of care. In France, more than 80% of MDD patients are enrolled in non-psychiatric care pathways, mainly primary care or MSO hospital care (medicine, surgery, obstetrics). Unfortunately, less than half of patients benefit from treatment at an appropriate dosage or duration, thus exposing them to the risks of relapse, recurrence and chronic evolution. It is necessary to optimize this management, in particular by improving secondary prevention, which consists of maintaining treatment in the months following symptomatic remission. Several support programs (monitoring with assessment of symptomatology) have shown their effectiveness on depressive symptomatology with a favorable medico-economic report, in particular by allowing maintenance of antidepressant treatment. None of these studies have been conducted on French care pathways. Investigators propose to evaluate the efficacy of telemedicine management (added to usual care) in non-psychiatric care pathways on the evolution of depressive symptomatology for MDD patients. Investigators hypothesize that telemedicine monitoring downstream of MSO hospitalization will increase the response rate to antidepressants at 6 months and reduce the costs attributed to depressive symptoms compared to usual care, in particular by optimizing secondary prevention strategies by maintaining treatment. The main objective of the research is to assess the efficacy of telemedicine monitoring on depressive symptoms and treatments, added to the out-of-hospital downstream care pathways for patients initially hospitalized in MSO (medicine-surgery-obstetrics), compared to usual care.

Conditions

Major Depressive Disorder

Keywords

Characterized depressive disorder; Telemedicine session

Outcome Measures

Primary Outcomes (1)

• Treatment response rate at 6 months after inclusion.

  The response to treatment is defined by a decrease of at least 50% in the Hospital Anxiety and Depression Scale (HADS-Depression) score compared to the baseline. The scale contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale. For the depression score, the minimum value is 0 and the maximum value is 21 in such a way that higher scores mean higher depressive symptoms intensity.

  At 6 months

Secondary Outcomes (24)

• Incremental cost-utility ratio over the 3 years of follow-up

  At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

• Incremental cost-utility ratio over the 3 years of follow-up

  A inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

• Quality of life score

  A inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

• Quality of life score

  At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

• Number of relapse episodes for the improvement of secondary prevention objective

  At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months

Study Arms (2)

Standard arm

NO INTERVENTION

Patients will have the usual care

Interventional arm

EXPERIMENTAL

Patients will have telemedicine session

Behavioral: Telemedicine session

Interventions

Telemedicine session BEHAVIORAL

The content of telemedicine session is semi-standardized and includes: (1) evaluation of the tolerance and efficacy of drug treatment; (2) evaluation of depressive symptoms (PHQ9 scale); (3) identification of the daily difficulties; (4 ) personalized advice and orientation towards appropriate care pathways. Among the personalized advice, investigators will use the digital tools available to maintain remission, psychoeducation and monitoring tools (for example, application to learn mindfulness meditation, conversational chatbot coupled with artificial intelligence, etc.). Support on the use of these tools can be provided during telemedicine sessions.

Interventional arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Presence of DSM5 criteria for the diagnosis of a characterized depressive episode
• Patient hospitalized in MCO with request for liaison psychiatry opinion whatever the hospitalization modality (full hospitalization, weekday hospitalization or day hospitalization)
• Initiation, change of molecule or modification of a psychotropic treatment (antidepressant or anxiolytic) during MCO hospitalization by the liaison psychiatrist
• Affiliated or entitled to a social security system (except AME)
• Obtaining free, written and informed consent

You may not qualify if:

• Severity of the depressive episode incompatible with outpatient care and relevant to an indication for hospitalization in psychiatry
• Patient is part of a psychiatric care program at the time of the selection visit
• Presence of a mood disorder other than CDD
• Reason for MCO hospitalization secondary to psychiatric disorders, in particular suicide attempts
• MCO hospitalization prolonged beyond 3 weeks after initiation, change of molecule or modification of psychotropic treatment dosage
• Psychiatric comorbidities assessed by psychiatrist, in particular addictions (excluding tobacco), delusional disorders, post-traumatic stress disorder, anxiety disorders (excluding GAD)
• High suicidal risk at the screening visit assessed by psychiatrist
• Presence of a non-psychiatric condition with a vital prognosis of less than 3 years
• Contraindications to telemedicine (no internet access, major vision problems, major cognitive problems, marked impulsivity, clinical situation requiring information to be communicated in person, etc.)
• Conditions making consent impossible (major cognitive disorders, etc.)
• Deprived of liberty or under a protective measure (guardianship or under curatorship)
• Pregnant woman
• Refusal of the patient

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jean Yves ROTGE, Pr

  Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Yves ROTGE, Pr

CONTACT

01 42 16 28 62; jeanyves.rotge@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: October 10, 2023
• Study Start: May 27, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): February 2, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)