Ireland
--:--IST
Recruiting Not applicable

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.

NCT05116514 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-09-27
Last updated
2025-12-31

Condition(s) studied

Psychotic Episode

Investigational drug(s) / intervention(s)

Case management

Case management: Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

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

Sex
ALL
Min age
16 Years
Max age
30 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of patients with recurrence of psychotic episode at least once between groups — 3 years
    Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) ≥ 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week.

Trial sites (6)

FacilityCityRegionStatus
CHU de TOULOUSE Toulouse Choisir Une Région Not Yet Recruiting
CH Saint Marie Clermont-Ferrand Clermont-Ferrand France Not Yet Recruiting
CHU de Montpellier Montpellier France Recruiting
CHU Nice Nice France Not Yet Recruiting
CHU de Nîmes Nîmes France Recruiting
Centre Hospitalier Léon-Jean Grégory Thuir France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05116514 on ClinicalTrials.gov ↗ ← All trials in France