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

ClinicalTrials.gov ID

NCT07705802

Lead Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur MerOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

2,000Estimated

Last Update Posted

Jul 16, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Sep 2030Estimated

Completion Date

Sep 2031Estimated

Official Title

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

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.

• Severe Mental Illness
• Severe Mental Disorder

• Observational follow-up

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur MerOTHER

Maxime.LELOUP@ght-atlantique17.fr

riad.chelha@ramsaysante.fr

adrien.joseph@aphp.fr

Quentin.QUELVEN@chu-rennes.fr

grouilj@ch-blois.fr

camille.foucault@ch-cahors.fr

agathe.delbove@ch-bretagne-atlantique.fr02 97 01 41 41 ext. +33

come.bureau@chu-lille.fr

nawel.gharnaout@aphp.fr

julien.mayaux@aphp.fr

luc.haudebourg@aphp.fr

julien.lemarec@aphp.fr

alexandra.beurton@aphp.fr

fphilippart@ghpsj.fr

cdupuis1@chu-clermontferrand.fr

edelpierre@ghef.fr

vhongtuanha@ghef.fr

mn.monchi@gmail.com

Julio.badie@hnfc.fr

jonathan.chelly@ch-toulon.fr04.94.14.51.24 ext. +33

michael.cardinale@intradef.gouv.fr

smerceron@ght78sud.fr

plouvierf@ch-agen-nerac.fr

Florent.MONTINI@ch-arles.fr

alexnica1979@gmail.com

JAlessandri@ch-dieppe.fr

J.ALPHONSINE@hopital-europeen.fr

wulfran.bougouin@gmail.com

Y.BENTOUMI@ghne.fr

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