Randomized Multicenter Clinical Trial of the Efficacy of a Telemedicine Monitoring in the Management of a Depressive Episode After an Hospitalisation in Medicine or Surgery
Trial ID: NCT06076317
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-05-27
Completion date: 2029-02-02
Sponsor: Assistance Publique - Hôpitaux de Paris
Conditions: Major Depressive Disorder
Interventions: Telemedicine session
Locations: Hôpital Pitié Salpêtrière
Countries: France
Enrollment: 836
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Outcomes:
Treatment response rate at 6 months after inclusion.