Severe Mental IllnessREPSYRENCT07705802
Outcome of Patients With Severe Mental Illness in the Intensive Care Unit
An observational study of Severe Mental Illness and Severe Mental Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 30 sites in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness, Severe Mental Disorder
- What is being tested?
- Observational follow-up
- How many people
- 2,000 participants
- Where
- 30 sitesFrance
- Study dates
- Sep 2026to Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites
Centre Hospitalier d'Agen-Nerac
Agen, 47923
Fabienne PLOUVIER, MD, plouvierf@ch-agen-nerac.fr
Centre Hospitalier d'Arles
Arles, 13200
Florent MONTINI, MD, Florent.MONTINI@ch-arles.fr
Centre Hospitalier Simone Veil
Blois, Loir-et-Cher, 41000
Julien GROUILLE, MD, grouilj@ch-blois.fr
CHU Ambroise Paré AP-HP
Boulogne-Billancourt, Hauts-de-Seine, 92100
Adrien JOSEPH, MD, adrien.joseph@aphp.fr
Centre Hospitalier de Cahors
Cahors, Lot, 46000
Camille Foucault, MD, camille.foucault@ch-cahors.fr
CHU de Clermont-Ferrand
Clermont-Ferrand, Puy-de-Dôme, 63000
Claire DUPUIS, MD, cdupuis1@chu-clermontferrand.fr
Centre Hospitalier Intercommunal de Compiègne-Noyon
Compiègne, 60200
Alexandru NICA, MD, alexnica1979@gmail.com
Centre Hospitalier de Dieppe
Dieppe, 76202
Jéromine ALESSANDRI, MD, JAlessandri@ch-dieppe.fr
Grand Hôpital de l'Est Francilien - Site de Jossigny
Jossigny, Seine-et-Marne, 77600
Eric DELPIERRE, MD, edelpierre@ghef.fr
Groupe Hospitalier Littoral Atlantique
La Rochelle, Charente-Maritime, 17019
Maxime LELOUP, MD, Maxime.LELOUP@ght-atlantique17.fr
Centre Hospitalier de Versailles
Le Chesnay, Yvelines, 78150
Sybille MERCERON, MD, smerceron@ght78sud.fr
CHU de Lille - Hôpital Roger Salengro
Lille, Nord, 59037
Côme BUREAU, MD, come.bureau@chu-lille.fr
Hôpital Européen Marseille
Marseille, 13331
Jean-Emmanuel ALPHONSINE, MD, J.ALPHONSINE@hopital-europeen.fr
Hôpital Privé Jacques Cartier - Ramsay Santé
Massy, 91300
Wulfran BOUGUOIN, MD, wulfran.bougouin@gmail.com
Grand Hôpital de l'Est Francilien - Site de Meaux
Meaux, Seine-et-Marne, 77100
Vivien HUONG TUAN HA, MD, vhongtuanha@ghef.fr
Groupe Hospitalier Sud Ile de France
Melun, Seine-et-Marne, 77000
Merhan MONCHI, MD, mn.monchi@gmail.com
Centre Hospitalier Universitaire de Nice
Nice, Alpes-Maritimes, 06001
Lucas MORAND, MD, morand.l@chu-nice.fr
Groupe Hospitalier Nord Essonne - Site Paris-Saclay
Orsay, 91400
Yasmine BENTOUMI, MD, Y.BENTOUMI@ghne.fr
Hôpital Saint Louis (AP-HP)
Paris, Paris, 75010
Nawel GHARNAOUT, MD, nawel.gharnaout@aphp.fr
Hôpital La Pitié Salpêtrière
Paris, Paris, 75013
Julien MAYAUX, MD, julien.mayaux@aphp.fr
Hôpital La Pitié Salpêtrière
Paris, Paris, 75013
Luc HAUDEBOURG, MD, luc.haudebourg@aphp.fr
Hôpital Bichat
Paris, Paris, 75018
Julien LE MAREC, MD, julien.lemarec@aphp.fr
Hôpital Tenon (AP-HP)
Paris, Paris, 75020
Alexandra BEURTON, MD, alexandra.beurton@aphp.fr
Hôpital Saint Joseph
Paris, Paris, 75674
François PHILIPPART, MD, fphilippart@ghpsj.fr
Hôpital privé Claude Galien
Quincy-sous-Sénart, Essonne, 91480
Riad Chelha, MD, riad.chelha@ramsaysante.fr
Centre Hospitalier Universitaire de Rennes
Rennes, Ille-et-Vilaine, 35033
Quentin QUELVEN, MD, Quentin.QUELVEN@chu-rennes.fr
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056
Jonathan Chelly, MD, 04.94.14.51.24 ext. +33, jonathan.chelly@ch-toulon.fr
Hôpital National d'Instruction des Armées de Sainte Anne
Toulon, Var, 83100
Michael CARDINALE, MD, michael.cardinale@intradef.gouv.fr
Hôpital Nord Franche Comté
Trévenans, Territoire de Belfort, 90400
Julio Badie, MD, Julio.badie@hnfc.fr
Centre Hospitalier Bretagne Atlantique de Vannes
Vannes, Morbihan, 56017
Agathe Delbove, MD, 02 97 01 41 41 ext. +33, agathe.delbove@ch-bretagne-atlantique.fr
About this study
Official title: Prospective Multicenter Study Assessing the Outcome of Patients With Severe Mental Illness Admitted to Intensive Care Units
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.
- Conditions
- Severe Mental Illness, Severe Mental Disorder
- Being tested
- Observational follow-up
- Keywords
- Severe mental illness, Intensive care unit, Patient outcome, Mortality, Frailty, ICU readmission, Severe mental disorder
- Medical subject headings
- Mental Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational follow-upOther
Standard care with a 12-month follow-up period to assess long-term outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe mental illness | 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. Receives: Other: Observational follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause ICU mortality rate
Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.
Measured: At ICU discharge (up to 1 month)
Secondary outcomes (5)
All-cause mortality rate at specific time points
Assessment of patient vital status (alive or deceased) for each specified time point.
Measured: 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.
Measured: Up to 12 months post-ICU admission
Number of ICU readmissions
Count of subsequent unscheduled admissions to the ICU for each patient.
Measured: 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.
Measured: 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.
Measured: At ICU discharge, 3 months, and 12 months post-initial ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan CHELLY, MD, Study director, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705802
- Sponsor's protocol ID
- 2026-CHITS-001
- Other IDs
- 2026-A00254-47
- Acronym
- REPSYRE
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study Assessing the Outcome of Patients With Severe Mental Illness Admitted to Intensive Care Units
- ClinicalTrials.gov ID
- NCT07705802
- Acronym / sponsor ID
- REPSYRE / 2026-CHITS-001
- Conditions
- Severe Mental Illness, Severe Mental Disorder
- Keywords
- Severe mental illness, Intensive care unit, Patient outcome, Mortality, Frailty, ICU readmission, Severe mental disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe mental illness | – | Other: Observational follow-upPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational follow-upStandard care with a 12-month follow-up period to assess long-term outcomes. | Other | Patients with severe mental illness |
Primary outcome
All-cause ICU mortality rate
Time frame: At ICU discharge (up to 1 month)
Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.
5 secondary outcomes
All-cause mortality rate at specific time points
Time frame: At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission
Time to death
Time frame: Up to 12 months post-ICU admission
Number of ICU readmissions
Time frame: 12 months
Glasgow Outcome Scale-Extended (GOSE) score
Time frame: At ICU discharge (up to 1 month), 3 months, and 12 months post-initial ICU admission
Clinical Frailty Scale (CFS) score
Time frame: At ICU discharge, 3 months, and 12 months post-initial ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan CHELLY, MD study director
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mental Illness and Severe Mental Disorder, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 30 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali CESANA, MSc (04 83 77 20 60 ext. +33, magali.cesana@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause ICU mortality rate (time frame: At ICU discharge (up to 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.