An observational study in Severe Mental Illness and Severe Mental Disorder, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Not yet recruiting at 30 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 220 across 389 observational studies indexed under Mental Disorders.
Browse Mental Disorders studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
All-cause ICU mortality rate
Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.
Time frame: At ICU discharge (up to 1 month)
All-cause mortality rate at specific time points
Assessment of patient vital status (alive or deceased) for each specified time point.
Time frame: At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission
Time to death
Evaluation of the exact survival time from ICU admission up to the end of the 12-month follow-up period.
Time frame: Up to 12 months post-ICU admission
Number of ICU readmissions
Count of subsequent unscheduled admissions to the ICU for each patient.
Time frame: 12 months
Glasgow Outcome Scale-Extended (GOSE) score
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.
Time frame: At ICU discharge (up to 1 month), 3 months, and 12 months post-initial ICU admission
Clinical Frailty Scale (CFS) score
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.
Time frame: At ICU discharge, 3 months, and 12 months post-initial ICU admission
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer