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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07705802
Acronym
REPSYRE
Enrollment
2000
Registered
2026-07-15
Start date
2026-09-01
Completion date
2031-09-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Mental Disorder, Severe Mental Illness

Keywords

Severe mental illness, Intensive care unit, Patient outcome, Mortality, Frailty, ICU readmission, Severe mental disorder

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.

Interventions

Standard care with a 12-month follow-up period to assess long-term outcomes.

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All-cause ICU mortality rateAt ICU discharge (up to 1 month)Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.

Secondary

MeasureTime frameDescription
All-cause mortality rate at specific time pointsAt ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admissionAssessment of patient vital status (alive or deceased) for each specified time point.
Time to deathUp to 12 months post-ICU admissionEvaluation of the exact survival time from ICU admission up to the end of the 12-month follow-up period.
Number of ICU readmissions12 monthsCount of subsequent unscheduled admissions to the ICU for each patient.
Glasgow Outcome Scale-Extended (GOSE) scoreAt ICU discharge (up to 1 month), 3 months, and 12 months post-initial ICU admissionEvaluation of global functioning and recovery using the GOSE score. The score ranges from 1 to 8, where higher scores indicate a better functional outcome.
Clinical Frailty Scale (CFS) scoreAt ICU discharge, 3 months, and 12 months post-initial ICU admissionEvaluation 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.

Countries

France

Contacts

CONTACTMagali CESANA, MSc
magali.cesana@ch-toulon.fr04 83 77 20 60
STUDY_DIRECTORJonathan CHELLY, MD

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026