Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2024
février 2029
17 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:32:32 | Contacter | |||
| AP-HP - Hôpital Charles Foix | |||||
| AP-HP - Hôpital Hôtel-Dieu | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
| AP-HP - Hôpital Tenon | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Pitié Salpêtrière - 75013 - Paris - France | Jean Yves ROTGE, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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