Status:
RECRUITING
Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Psychotic Episode
Eligibility:
All Genders
16-30 years
Phase:
NA
Brief Summary
The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from...
Eligibility Criteria
Inclusion Criteria:
-
The patient or their close relative must have given their free and informed consent and signed the consent form
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The patient must be a member or beneficiary of a health insurance plan
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The patient is available for a 3-year follow-up.
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Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:
- Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
- Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
- A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
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Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
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At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.
Exclusion Criteria:
- The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- The subject, or one of the parents for minor patients, refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patients has an IQ less than or equal to 55
- The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
- The patient is pregnant or breastfeeding
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT05116514
Start Date
September 27 2021
End Date
November 1 2028
Last Update
December 31 2025
Active Locations (6)
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1
CHU de TOULOUSE
Toulouse, Choisir Une Région, France, 31
2
CH Saint Marie Clermont-Ferrand
Clermont-Ferrand, France
3
CHU de Montpellier
Montpellier, France
4
CHU Nice
Nice, France