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.

Recruiting now · Not applicable

Conditions studied: Psychotic Episode

In brief

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 the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration

Key facts

Study ID

NCT05116514

Run by

Centre Hospitalier Universitaire de Nīmes

People needed

256

Starts

2021-09-27

Expected to finish

2028-11-01

Last updated by the study team

2025-12-31

Who can join

Age: 16 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient or their close relative must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is available for a 3-year follow-up.
• 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.
• Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
• At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.

You may not qualify if…

• 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

Where it is running

• CHU de Montpellier — Montpellier, France (enrolling)
• CHU de Nîmes — Nîmes, France (enrolling)
• Centre Hospitalier Léon-Jean Grégory — Thuir, France (enrolling)
• CHU de TOULOUSE — Toulouse, Choisir Une Région, France
• CH Saint Marie Clermont-Ferrand — Clermont-Ferrand, France
• CHU Nice — Nice, France

Full record on ClinicalTrials.gov

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