Outcome of Patients With Severe Mental Illness in the Intensive Care Unit (REPSYRE)

July 10, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Prospective Multicenter Study Assessing the Outcome of Patients With Severe Mental Illness Admitted to Intensive Care Units

Severe mental illnesses (SMIs), such as major depression, schizophrenia, and bipolar disorder, carry a significant prevalence among patients admitted to the intensive care unit (ICU), estimated at an average of 19%. Evidence indicates that ICU hospitalization is associated with a poorer prognosis regarding mental health and morbi-mortality compared to hospitalization in conventional wards.

Despite this recognized vulnerability, available data remain limited and are often derived from retrospective studies with conflicting results. Some studies have shown that SMIs impact neither critical care nor long-term mortality. Conversely, other research has reported higher hospital mortality, an increase in complications (such as mechanical ventilation and prolonged length of stay), and unfavorable functional outcomes. Regarding specific conditions like septic shock, unexpected findings have been observed, with certain SMIs appearing to be associated with reduced 90-day mortality compared to a matched control population.

Patients with SMIs thus represent a vulnerable population whose management in the ICU setting may pose specific challenges. This prospective, multicenter study aims to evaluate mortality and identify predictive factors of mortality among patients with SMIs managed in French ICUs.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Agen, France, 47923
      • Arles, France, 13200
      • Compiègne, France, 60200
        • Centre Hospitalier Intercommunal de Compiègne-Noyon
        • Contact:
      • Dieppe, France, 76202
      • Marseille, France, 13331
      • Massy, France, 91300
      • Orsay, France, 91400
        • Groupe Hospitalier Nord Essonne - Site Paris-Saclay
        • Contact:
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
    • Charente-Maritime
    • Essonne
      • Quincy-sous-Sénart, Essonne, France, 91480
    • Hauts-de-Seine
      • Boulogne-Billancourt, Hauts-de-Seine, France, 92100
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
    • Loir-et-Cher
      • Blois, Loir-et-Cher, France, 41000
    • Lot
    • Morbihan
    • Nord
      • Lille, Nord, France, 59037
    • Paris
      • Paris, Paris, France, 75010
      • Paris, Paris, France, 75013
      • Paris, Paris, France, 75018
      • Paris, Paris, France, 75020
      • Paris, Paris, France, 75674
    • Puy-de-Dôme
    • Seine-et-Marne
      • Jossigny, Seine-et-Marne, France, 77600
        • Grand Hôpital de l'Est Francilien - Site de Jossigny
        • Contact:
      • Meaux, Seine-et-Marne, France, 77100
        • Grand Hôpital de l'Est Francilien - Site de Meaux
        • Contact:
      • Melun, Seine-et-Marne, France, 77000
    • Territoire de Belfort
      • Trévenans, Territoire de Belfort, France, 90400
    • Var
      • Toulon, Var, France, 83056
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
        • Contact:
      • Toulon, Var, France, 83100
    • Yvelines
      • Le Chesnay, Yvelines, France, 78150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with severe mental illnesses admitted to the ICU for unscheduled medical management, urgent post-operative care, or due to a complication of elective surgery.

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Admission to a participating ICU.
  • Unscheduled ICU admission for medical management, urgent post-operative care, or due to a complication of elective surgery.
  • Pre-existing diagnosis of a severe mental illness prior to ICU admission, according to DSM-5 criteria: schizophrenia, schizoaffective disorder, severe major depressive episode, chronic depressive disorder, recurrent depressive disorder, or bipolar disorders.
  • Current chronic treatment with psychotropic medication at the time of enrollment (antidepressants, neuroleptics, other antipsychotics, lithium, or antiepileptic drugs used as mood stabilizers).
  • Non-opposition to participate from the patient; if the patient is unable to receive information, non-opposition from a relative/trusted person; for patients under guardianship or curatorship, non-opposition from both the legal guardian and the patient.

Exclusion Criteria:

  • Scheduled ICU admission following elective surgery.
  • Prior enrollment in the REPSYRE study.
  • Inability to speak or understand French.
  • Homeless patients or individuals deprived of liberty.
  • Any other condition or reason that, in the investigator's judgment, might interfere with the evaluation of the study objectives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with severe mental illness
Patients with severe mental illnesses (Schizophrenia, schizoaffective disorder, severe major depressive episode, chronic depressive disorder, recurrent depressive disorder, or bipolar disorders) admitted to the intensive care unit for unscheduled medical management, urgent post-operative care, or due to a complication of elective surgery.
Other: Observational follow-up
Standard care with a 12-month follow-up period to assess long-term outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital status
Time Frame: At ICU discharge (up to 1 month)
Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.
At ICU discharge (up to 1 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital status at specific time points
Time Frame: At ICU discharge, 3 months, and 12 months post-ICU admission
Assessment of patient vital status (alive or deceased).
At ICU discharge, 3 months, and 12 months post-ICU admission
Time to death
Time Frame: Up to 12 months post-ICU admission
Evaluation of the exact survival time from ICU admission up to the end of the 12-month follow-up period.
Up to 12 months post-ICU admission
Number of ICU readmissions
Time Frame: 12 months
Count of subsequent unscheduled admissions to the ICU for each patient.
12 months
Glasgow Outcome Scale-Extended (GOSE) score
Time Frame: At ICU discharge, 3 months, and 12 months post-initial ICU admission
Evaluation of global functioning and recovery using the GOSE score. The score ranges from 1 to 8, where higher scores indicate a better functional outcome.
At ICU discharge, 3 months, and 12 months post-initial ICU admission
Clinical Frailty Scale (CFS) score
Time Frame: At ICU discharge, 3 months, and 12 months post-initial ICU admission
Evaluation of the patient's overall level of fitness and frailty using the CFS. The scale ranges from 1 to 9, where higher scores indicate greater frailty.
At ICU discharge, 3 months, and 12 months post-initial ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: Jonathan CHELLY, MD, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-CHITS-001
  • 2026-A00254-47 (Other Identifier: ID RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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