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 | Recruiting

• 1 other identifier: PREPS/2018/AS-01
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 6

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 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

Conditions

Psychotic Episode

Outcome Measures

Primary Outcomes (1)

• Rate of patients with recurrence of psychotic episode at least once between groups

  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.

  3 years

Secondary Outcomes (194)

• Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

  1 year

• Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

  2 years

• Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient

  3 years

• Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

  1 year

• Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient

  2 years

Study Arms (2)

Case manager group

EXPERIMENTAL

Other: Case management

Control

NO INTERVENTION

Interventions

Case management OTHER

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

Case manager group

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

CHU de TOULOUSE

Toulouse, Choisir Une Région, 31, France

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

Related Publications (1)

• Schandrin A, Jourdan J, Chkair S, Bouvet S, Fabbro-Peray P, Abbar M; PEPsy-CM working group. PEPsy-CM study protocol: impact of a 3-year program for early psychosis based on case-management on relapse rate, a French multicenter randomized trial. BMC Psychiatry. 2025 May 15;25(1):488. doi: 10.1186/s12888-025-06940-y.

  PMID: 40375175 BACKGROUND

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Aurélie Schandrin

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie Schandrin

CONTACT

04.66.68.34.26; aurelie.schandrin@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 11, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (6)