Psychotic EpisodePRESTONCT05813457
Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis
A study testing PRESTO Early Identification Program in people with Psychotic Episode, run by Centre Hospitalier Universitaire de Saint Etienne at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Psychotic Episode
- What is being tested?
- PRESTO Early Identification Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 6 sitesFrance
- Study dates
- 6 Jun 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients already treated and followed for FPE
- Brief psychotic state not requiring specific management
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Hospices Civils de Lyon
Bron, 69500
Frédéric HAESEBAERT, MD
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Guillaume LEGRAND, MD
- Recruiting
Chu Grenoble
Grenoble, 38000
Clément DONDE, MD
- Recruiting
CHU de Montpellier
Montpellier, 34090
MD
Alexandra CARRE, MD
- Recruiting
CHU de Nîmes
Nîmes, 30900
Aurélie SCHANDRIN, MD
- Recruiting
Chu Saint Etienne
Saint-Etienne, 42100
Eric FAKRA, MD PhD
Eric FAKRA, MD PhD
About this study
Official title: Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study
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
Read the detailed description
The DUP is an easily measurable indicator, closely linked to prognosis and potentially modifiable, which has led to its wide use to guide the development of early identification programs. Great disparities exist across the world, between different countries and even different regions. France is unusually late, with an average DUP of at least 18 months. Several elements may contribute to explain this state in France: absence of a specific care program for FPE in the vast majority of psychiatric centers, significant stigmatization of psychiatric illnesses, the opacity of psychiatric care and of psychiatric care and lack of knowledge of its organization, in particular by the primary care network that receives patients with PEP in the first line. To date, there is no systematic program in France designed to rapidly identify FPE patients and hasten their specialized 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.
In addition, this study will seek to analyze the implementation factors of such an intervention in view of a possible generalization and perpetuation.
- Conditions
- Psychotic Episode
- Being tested
- PRESTO Early Identification Program
- Keywords
- Schizophrenia, Psychiatric centers, psychiatric illnesses, psychiatric care
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESTO Early Identification ProgramOther
Also called PRESTO Program
The program combines :
- A population-based information component (information campaign aimed at the general population).
- 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.).
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: PRESTO Early Identification Program |
| Usual Care | No intervention | No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (7)
Number of patients still in care
measurement of the number of patients continuing care
Measured: Week 4
Engagement in care
Measurement of engagement in care through the Service Engagement Scale. It is a 14-item questionnaire, scored from 0 to 3, divided into four categories: availability, cooperation, help-seeking attitude and therapeutic adherence. The questionnaire is completed by the clinician.
Measured: Week 4
treatment adherence
Medication Adherence Rating Scale (MARS) is a 10-item self-reporting multidimensional instrument describing three dimensions: medication adherence behavior (items 1-4), attitude toward taking medication (items 5-8) and negative side effects and attitudes to psychotropic medication (items 9-10). The total score ranges from 0-10 with a higher score indicating better adherence.
Measured: Week 4
therapeutic alliance
measurement of the therapeutic alliance with the "Working Alliance Inventory" self-questionnaire given to the patient and the clinician. It is a self-administered questionnaire with a 36-item therapist or caregiver component and a 36-item patient component. Each item is rated from 1 to 7 (never to always). The score range is 36 to 252. Higher score reflect a more positive rating of working alliance.
Measured: Week 4
Customer satisfaction
Measurement of Customer satisfaction by self-questionnaire with 8 items applicable to a population with psychotic disorders. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Week 4
Caregiver Burden
Measurement of Caregiver Burden by the Zarit Burden Interview in Caregivers of Patients is a self-questionnaire given to the caregiver. This questionnaire consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0 to 88. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Measured: Baseline and week 4
Assessment of the context
Semi-structured interview wera done with stakeholders of PRESTO program to assess contextual factors that increase or limit the effect of the intervention, integration of the intervention into the care organization scheme, collaboration with inpatient, outpatient and non-healthcare sectors, means identified to sustain the intervention.
Measured: before the start and after the end of the PRESTO program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start6 Jun 2023
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic EpisodeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric FAKRA, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813457
- Sponsor's protocol ID
- 19PH228
- Other IDs
- 2021-A00787-34
- Acronym
- PRESTO
- Status last verified
- Nov 2025
- First submitted
- 3 Apr 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study
- ClinicalTrials.gov ID
- NCT05813457
- Acronym / sponsor ID
- PRESTO / 19PH228
- Conditions
- Psychotic Episode
- Keywords
- Schizophrenia, Psychiatric centers, psychiatric illnesses, psychiatric care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The DUP is an easily measurable indicator, closely linked to prognosis and potentially modifiable, which has led to its wide use to guide the development of early identification programs. Great disparities exist across the world, between different countries and even different regions. France is unusually late, with an average DUP of at least 18 months. Several elements may contribute to explain this state in France: absence of a specific care program for FPE in the vast majority of psychiatric centers, significant stigmatization of psychiatric illnesses, the opacity of psychiatric care and of psychiatric care and lack of knowledge of its organization, in particular by the primary care network that receives patients with PEP in the first line. To date, there is no systematic program in France designed to rapidly identify FPE patients and hasten their specialized 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.
In addition, this study will seek to analyze the implementation factors of such an intervention in view of a possible generalization and perpetuation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRESTO program | Experimental | Other: PRESTO Early Identification ProgramThe 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 |
| Usual Care | No intervention | –No change in the conditions of referral of First Episod Psychosis (emergencies, hospitalizations, consultations) |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients already treated and followed for FPE
- Brief psychotic state not requiring specific management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRESTO Early Identification ProgramAlso: PRESTO ProgramThe 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) | Other | PRESTO program |
Primary outcome
Duration of untreated psychosis (DUP)
Time frame: Baseline
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
7 secondary outcomes
Number of patients still in care
Time frame: Week 4
Engagement in care
Time frame: Week 4
treatment adherence
Time frame: Week 4
therapeutic alliance
Time frame: Week 4
Customer satisfaction
Time frame: Week 4
Caregiver Burden
Time frame: Baseline and week 4
Assessment of the context
Time frame: before the start and after the end of the PRESTO program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric FAKRA, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRESTO Early Identification Program in people with Psychotic Episode, run by Centre Hospitalier Universitaire de Saint Etienne at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric FAKRA, MD PhD ((0)477127885 ext. +33, eric.fakra@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of untreated psychosis (DUP) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.