Outcome of Patients With Severe Mental Illness in the Intensive Care Unit
REPSYRE
Prospective Multicenter Study Assessing the Outcome of Patients With Severe Mental Illness Admitted to Intensive Care Units
2 other identifiers
observational
2,000
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2026
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2026
CompletedFirst Posted
Study publicly available on registry
July 15, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2030
Study Completion
Last participant's last visit for all outcomes
September 1, 2031
July 16, 2026
July 1, 2026
4 years
July 10, 2026
July 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause ICU mortality rate
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 Outcomes (5)
All-cause mortality rate at specific time points
At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission
Time to death
Up to 12 months post-ICU admission
Number of ICU readmissions
12 months
Glasgow Outcome Scale-Extended (GOSE) score
At ICU discharge (up to 1 month), 3 months, and 12 months post-initial ICU admission
Clinical Frailty Scale (CFS) score
At ICU discharge, 3 months, and 12 months post-initial ICU admission
Study Arms (1)
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.
Interventions
Standard care with a 12-month follow-up period to assess long-term outcomes.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Centre Hospitalier Universitaire de Nice
Nice, Alpes-Maritimes, 06001, France
Groupe Hospitalier Littoral Atlantique
La Rochelle, Charente-Maritime, 17019, France
Hôpital privé Claude Galien
Quincy-sous-Sénart, Essonne, 91480, France
CHU Ambroise Paré AP-HP
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
Centre Hospitalier Universitaire de Rennes
Rennes, Ille-et-Vilaine, 35033, France
Centre Hospitalier Simone Veil
Blois, Loir-et-Cher, 41000, France
Centre Hospitalier de Cahors
Cahors, Lot, 46000, France
Centre Hospitalier Bretagne Atlantique de Vannes
Vannes, Morbihan, 56017, France
CHU de Lille - Hôpital Roger Salengro
Lille, Nord, 59037, France
Hôpital Saint Louis (AP-HP)
Paris, Paris, 75010, France
Hôpital La Pitié Salpêtrière
Paris, Paris, 75013, France
Hôpital La Pitié Salpêtrière
Paris, Paris, 75013, France
Hôpital Bichat
Paris, Paris, 75018, France
Hôpital Tenon (AP-HP)
Paris, Paris, 75020, France
Hôpital Saint Joseph
Paris, Paris, 75674, France
CHU de Clermont-Ferrand
Clermont-Ferrand, Puy-de-Dôme, 63000, France
Grand Hôpital de l'Est Francilien - Site de Jossigny
Jossigny, Seine-et-Marne, 77600, France
Grand Hôpital de l'Est Francilien - Site de Meaux
Meaux, Seine-et-Marne, 77100, France
Groupe Hospitalier Sud Ile de France
Melun, Seine-et-Marne, 77000, France
Hôpital Nord Franche Comté
Trévenans, Territoire de Belfort, 90400, France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056, France
Hôpital National d'Instruction des Armées de Sainte Anne
Toulon, Var, 83100, France
Centre Hospitalier de Versailles
Le Chesnay, Yvelines, 78150, France
Centre Hospitalier d'Agen-Nerac
Agen, 47923, France
Centre Hospitalier d'Arles
Arles, 13200, France
Centre Hospitalier Intercommunal de Compiègne-Noyon
Compiègne, 60200, France
Centre Hospitalier de Dieppe
Dieppe, 76202, France
Hôpital Européen Marseille
Marseille, 13331, France
Hôpital Privé Jacques Cartier - Ramsay Santé
Massy, 91300, France
Groupe Hospitalier Nord Essonne - Site Paris-Saclay
Orsay, 91400, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jonathan CHELLY, MD
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2026
First Posted
July 15, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2030
Study Completion (Estimated)
September 1, 2031
Last Updated
July 16, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share