Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06076317

Relevance of a Telemedicine Monitoring in the Management of Depression

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-22

836

Participants Needed

1

Research Sites

244 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Relevance of a Telemedicine Monitoring in the Management of Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of a depressive episode meeting DSM5 criteria
  • Hospitalized in medicine, surgery, or obstetrics unit with liaison psychiatry evaluation
  • Starting or changing antidepressant or anxiolytic treatment during hospitalization
  • Affiliated with a social security system (except AME)
  • Provided free, written informed consent
Not Eligible

You will not qualify if you...

  • Depressive episode severity requiring psychiatric hospitalization
  • Currently enrolled in a psychiatric care program
  • Presence of mood disorders other than characterized depressive disorder
  • Hospitalization due to psychiatric reasons such as suicide attempts
  • Hospitalization longer than 3 weeks after treatment initiation or change
  • Psychiatric comorbidities including addictions (except tobacco), delusions, PTSD, or anxiety disorders (except general anxiety disorder)
  • High suicide risk at screening
  • Non-psychiatric illness with life expectancy under 3 years
  • Contraindications to telemedicine such as no internet access or major cognitive issues
  • Unable to give consent due to cognitive impairment
  • Deprived of liberty or under legal protection measures
  • Pregnancy
  • Patient refusal

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

J

Jean Yves ROTGE, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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