Not Yet RecruitingNot Applicable

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

France2,000 participantsStarted 2026-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is focused on patients with severe mental illness who end up in the ICU, can you help me understand whether my specific diagnosis and situation would be relevant to what this study is trying to learn?
2This trial hasn't started recruiting yet — do you know when it's expected to open, and is it worth waiting to see if I might be eligible, or should we focus on other options in the meantime?
3The main thing this study is measuring is whether patients with severe mental illness are more or less likely to survive an ICU stay — since it's an observational study, does participating mean any changes to how I'd actually be treated in the ICU?
4Since this appears to be an observational study tracking outcomes rather than testing a new treatment, what would I actually be asked to do or agree to if I were to participate?
5Given that the study is looking at ICU outcomes for people with severe mental illness, what does my care team already know about how my mental health diagnosis might affect my care if I ever needed intensive treatment?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-cause ICU mortality rate

Timeframe: At ICU discharge (up to 1 month)

Trial details

NCT IDNCT07705802

SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-09

Contact for this trial

Magali CESANA, MSc

04 83 77 20 60 magali.cesana@ch-toulon.fr

View on ClinicalTrials.gov More Severe Mental Illness trials