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

July 15, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause ICU mortality rate
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
All-cause mortality rate at specific time points
Time Frame: At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission
Assessment of patient vital status (alive or deceased) for each specified time point.
At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission
Glasgow Outcome Scale-Extended (GOSE) score
Time Frame: At ICU discharge (up to 1 month), 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 (up to 1 month), 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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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