ClinicalTrials.gg
Sign In
RecruitingNCT05349513IEvaEcoSchiUpdated Oct 23, 2026

Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders

An interventional study of ESSME questionnaire in Patients With Schizophrenia-like Disorders, sponsored by Centre Hospitalier Henri Laborit. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Centre Hospitalier Henri Laborit · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Updated Oct 23, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The study use a new ecological questionnaire called ESSME developed by a care team in order to evaluate ecological environment of patients with schizophrenia-like disorders.

Indeed, evaluation in an ecological environment would make it possible to be as close as possible to the concerns of theses patients, which could improve the care of this population, by making it possible to set with the patient objectives anchored in their daily life.

Read the detailed description

The duration of patient's participation to the study is 6 months plus 7 to 14 days.

The study includes the following visits :

  • V0: Inclusion visit (Day 0) with the administration of standard of care questionnaires;
  • V1: visit at patient's home (Day 0 +7 to 14 days) with the administration of the experimental ESSME questionnaire;
  • V2: follow-up visit at 6 months (M6) with the administration of the same standard of care questionnaires than at the inclusion visit;
  • V3: visit at patient's home (M6 + 7 to 14 days) with the administration of the experimental ESSME questionnaire.
02

Conditions studied

  • Patients With Schizophrenia-like Disorders

Browse trials for

03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 56 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Centre Hospitalier Henri Laborit is the lead sponsor of 27 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • man or woman aged 18 to 65 inclusive;
  • diagnosis of schizophrenia or schizoaffective disorder according to the version number 5 (DSM-V) criteria;
  • patient receiving care in a Center for Rehabilitation and Intersectoral Therapeutic Activities (CREATIV);
  • person who consented to the study;
  • affiliate or beneficiary of a social security scheme.

Exclusion criteria

Exclusion Criteria:

  • patient aged under 18 or over 65;
  • pregnant or breastfeeding women;
  • person unable or unwilling to receive a home visit;
  • person not consenting to the study;
  • presence of a diagnosis of an associated neurodevelopmental disorder;
  • presence of a diagnosis of dementia or associated neurodegenerative process;
  • person with a level of French language insufficient to understand the items.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    interventionnal arm

    Administration of the experimental questionnaire ESSME in patient's environment.

    Other: ESSME questionnaire

Interventions

  • OtherESSME questionnaire

    The experimental ecological questionnaire ESSME is administered 7 to 14 days after the inclusion visit and 7 to 14 days after the 6 months follow-up visit to the patient at their home.

06

What researchers measure

Primary outcomes

  1. Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale.

    The main judgment criterion is the correlation coefficient between the change in the total ESSME score and the change in the total score of the selected autonomy scale, the EAS over a period of 6 months. The judgment criterion will be obtained by calculating a percentage variation between the initial total score and that obtained at 6 months for each of the scales: EAS and for the ESSME tool.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Feb 2027, 60 months after the start.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 60 months is above that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: primary completion Feb 2026 → Feb 2027 and completion Feb 2026 → Feb 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2022
First posted
Apr 27, 2022
StartActual
Feb 23, 2022
Primary completionEst.
Feb 2027was Feb 2026
CompletionEst.
Feb 2027was Feb 2026
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Feb 2026→Feb 2027
Oct 23, 2026
Study completion
Feb 2026→Feb 2027
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Primary completion Feb 2026→Feb 2027
    Study completion Feb 2026→Feb 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05349513
Lead sponsor
Centre Hospitalier Henri Laborit
Responsible party
Sponsor
First posted
Apr 27, 2022
Start date
Feb 23, 2022
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Carole WANGERMEZ
Contact
carole.wangermez@ch-poitiers.fr
+33 5 49 38 00 19

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Schizophrenia →

Other studies from this sponsor

Centre Hospitalier Henri Laborit

Start the discussion