Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis

NCT05813457 | Recruiting

• 2 other identifiers: 19PH2282021-A00787-34
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 6

Brief Summary

The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia. Numerous studies show that the rapidity of the initial management of FPE would reduce the risk of negative evolution and would have a decisive impact on the short and long term prognosis. The rapidity of this management can be measured by the duration of untreated psychosis, or DUP (Duration of Untreated Psychosis), the time interval between the appearance of the first frank psychotic symptoms and the initiation of adequate psychiatric care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. This intervention consists of an early identification program for FPE, the PRESTO program, specifically targeting 3 determining steps in the reduction of DUP:

• Informing the general population about psychotic disorders
• Knowledge of front line actors (APL: general practitioners, school and university medicine, teenager's house, associative networks educators, emergency services, firefighters, etc.) about FPE and its management
• Articulation between APL and specialized psychiatric care

Conditions

Psychotic Episode

Keywords

Schizophrenia; Psychiatric centers; psychiatric illnesses; psychiatric care

Outcome Measures

Primary Outcomes (1)

• Duration of untreated psychosis (DUP)

  Defines the time interval between the onset of the first frank psychotic signs noted by the patient and his or her entourage and treatment in specialized psychiatric care

  Baseline

Secondary Outcomes (7)

• Number of patients still in care

  Week 4

• Engagement in care

  Week 4

• treatment adherence

  Week 4

• therapeutic alliance

  Week 4

• Customer satisfaction

  Week 4

Study Arms (2)

PRESTO program

EXPERIMENTAL

The PRESTO programs consists of an early identification program for First Episod Psychosis, called PRESTO (First Episodes Raise Awareness Treat Referral), including 3 complementary components: * Information campaign for the general population * Training of front-line actors * Facilitating access to specialized care by setting up mobile teams made up of "pivotal" workers who provide the link between front-line actors and specialized psychiatric care

Other: PRESTO Early Identification Program

Usual Care

NO INTERVENTION

No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations)

Interventions

PRESTO Early Identification Program OTHER

The program combines : 1. A population-based information component (information campaign aimed at the general population). 2. A training component for the LPAs (Front Line Actors: general practitioners, school and university medicine, pharmacists, teenagers school and university medicine, pharmacists, teenagers' homes, association networks, SAMU, firemen, etc.). 3. Facilitated access to care for FPE patients in the form of a "pivot" mobile team that can directly meet the patient at the request of the LPA, initiate care and ensure the relay within a the relay within 4 weeks to the existing specialized psychiatric structures on the site (CMP, CATTP (CMP, CATTP, day hospital, hospitalization unit, child and adolescent psychiatry services) adolescent psychiatry services)

Also known as: PRESTO Program

PRESTO program

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or brief psychotic disorder established according to DMS 5
• Never having taken neuroleptic treatment for antipsychotic purposes, except for the current episode and for a duration of \< 6 month
• Oral consent of the patient or, for minors, of his/her parents to participate in the study

You may not qualify if:

• Patients already treated and followed for FPE
• Brief psychotic state not requiring specific management

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (6)

Hospices Civils de Lyon

Bron, 69500, France

RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Chu Grenoble

Grenoble, 38000, France

RECRUITING

CHU de Montpellier

Montpellier, 34090, France

RECRUITING

CHU de Nîmes

Nîmes, 30900, France

RECRUITING

Chu Saint Etienne

Saint-Etienne, 42100, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Eric FAKRA, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric FAKRA, MD PhD

CONTACT

(0)477127885; eric.fakra@chu-st-etienne.fr

Amandine BAUDOT, CRA

CONTACT

(0)477829450; amandine.baudot@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: June 6, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)