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Mental health in the ICU: a 2,000-Patient study aims to uncover hidden risks

NCT ID NCT07705802

Knowledge-focused Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study follows 2,000 adults with severe mental illness (such as schizophrenia, bipolar disorder, or severe depression) who are admitted to intensive care units (ICUs) in France. Researchers track their survival and other outcomes for up to 12 months to identify factors that predict recovery or complications. The goal is to fill gaps in knowledge about how this vulnerable group responds to critical care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how to better care for people with severe mental illness in intensive care, potentially reducing deaths and complications.
What could go wrong
This is an observational study, not a treatment trial, so it cannot prove what works. Results may vary across different ICUs and patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bipolar disorder dysthymic disorder Frailty major depressive disorder mental disorder psychiatric disorder schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe mental disorder Severe mental illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Ambroise Paré AP-HP

    Boulogne-Billancourt, Hauts-de-Seine, 92100, France

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, Puy-de-Dôme, 63000, France

  • CHU de Lille - Hôpital Roger Salengro

    Lille, Nord, 59037, France

  • Centre Hospitalier Bretagne Atlantique de Vannes

    Vannes, Morbihan, 56017, France

  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    Toulon, Var, 83056, France

  • Centre Hospitalier Intercommunal de Compiègne-Noyon

    Compiègne, 60200, France

  • Centre Hospitalier Simone Veil

    Blois, Loir-et-Cher, 41000, France

  • Centre Hospitalier Universitaire de Nice

    Nice, Alpes-Maritimes, 06001, France

  • Centre Hospitalier Universitaire de Rennes

    Rennes, Ille-et-Vilaine, 35033, France

  • Centre Hospitalier d'Agen-Nerac

    Agen, 47923, France

  • Centre Hospitalier d'Arles

    Arles, 13200, France

  • Centre Hospitalier de Cahors

    Cahors, Lot, 46000, France

  • Centre Hospitalier de Dieppe

    Dieppe, 76202, France

  • Centre Hospitalier de Versailles

    Le Chesnay, Yvelines, 78150, 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 Littoral Atlantique

    La Rochelle, Charente-Maritime, 17019, France

  • Groupe Hospitalier Nord Essonne - Site Paris-Saclay

    Orsay, 91400, France

  • Groupe Hospitalier Sud Ile de France

    Melun, Seine-et-Marne, 77000, France

  • Hôpital Bichat

    Paris, Paris, 75018, France

  • Hôpital Européen Marseille

    Marseille, 13331, France

  • Hôpital La Pitié Salpêtrière

    Paris, Paris, 75013, France

  • Hôpital La Pitié Salpêtrière

    Paris, Paris, 75013, France

  • Hôpital National d'Instruction des Armées de Sainte Anne

    Toulon, Var, 83100, France

  • Hôpital Nord Franche Comté

    Trévenans, Territoire de Belfort, 90400, France

  • Hôpital Privé Jacques Cartier - Ramsay Santé

    Massy, 91300, France

  • Hôpital Saint Joseph

    Paris, Paris, 75674, France

  • Hôpital Saint Louis (AP-HP)

    Paris, Paris, 75010, France

  • Hôpital Tenon (AP-HP)

    Paris, Paris, 75020, France

  • Hôpital privé Claude Galien

    Quincy-sous-Sénart, Essonne, 91480, France

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