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.

Last updated: February 11, 2025
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Psychosis

Treatment

Case management

Clinical Study ID

NCT05116514
PREPS/2018/AS-01
  • Ages 16-30
  • All Genders

Study 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 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient or their close relative must have given their free and informed consentand 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 afirst 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 dailyor at least 3 times per week for at least one hour per occasion ;

  • Never having taken a neuroleptic treatment with antipsychotic aim (except foran antipsychotic treatment started for the current episode for example by thegeneral practitioner before being referred to psychiatry);

  • A disorder meeting the DSM 5 criteria from the following list: delusionaldisorder, brief psychotic disorder greater than 7 days, schizophreniformdisorder, schizophrenia, schizoaffective disorder, substance-induced psychoticdisorder greater than 7 days, other specific or nonspecific schizophrenicspectrum disorder or other psychotic disorder, bipolar I or II disorder withcongruent and non-mood congruent psychotic features, bipolar disorder withcongruent and non-mood congruent psychotic features induced by a substance,major depressive disorder with congruent and non-mood congruent psychoticfeatures.

  • Inclusion should be within the first 3 months of care for first episode psychosis inthe psychiatric service.

  • At the time of inclusion, the psychotic symptomatology observed during the firstepisode psychosis may still be present or in remission.

Exclusion

Exclusion Criteria:

  • The subject is participating in another category I interventional study, or is in aperiod 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 bya medication of other medical condition

  • The patient is pregnant or breastfeeding

Study Design

Total Participants: 256
Treatment Group(s): 1
Primary Treatment: Case management
Phase:
Study Start date:
September 27, 2021
Estimated Completion Date:
November 30, 2028

Connect with a study center

  • CHU de TOULOUSE

    Toulouse, Choisir une région 31
    France

    Site Not Available

  • CH Saint Marie Clermont-Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CH de la Conception

    Marseille,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU Nice

    Nice,
    France

    Site Not Available

  • CHU de Nîmes

    Nîmes,
    France

    Active - Recruiting

  • CHU Saint Etienne

    Saint-Étienne,
    France

    Site Not Available

  • Centre Hospitalier Léon-Jean Grégory

    Thuir,
    France

    Active - Recruiting

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