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

  • 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.

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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

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