SchizophreniaPEPsyNCT02670447
Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies
An observational study of Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial summary
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- 11 Dec 2025to Apr 2031
- Phase
- Observational
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients suffering of schizophrenia will be included in this study. They do not have ever taken anti-psychotic treatment.
Who may be able to join
- men and women aged 18-35 years
- member or beneficiary of a social security scheme,
- for women, appropriate contraception will be mandatory, as well as a negative pregnancy test,
- patients with a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to the DMS V
- having never received anti-psychotic treatment,
- followed in the hospital or outpatient,
- having given their written informed consent,
- that the physical examination revealed no significant clinical abnormalities
Who cannot join
- Female patients of childbearing period without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
- Patients pregnant or nursing;
- Presenting a serious somatic or neurological disease, especially Parkinson's disease, epilepsy, debilitating tardive dyskinesia, cardiovascular disease, severe liver or kidney;
- Featuring against-indication for an MRI; including: metallic foreign body eye or intracranial, pacemaker, heart valve, surgical clips, claustrophobia, large tattoo in the upper part of the body, not compatible with 3T MRI
- Having a history of alcohol or drug abuse in the past year;
- Participating in another clinical trial or being in an exclusion period of the previous protocol;
- Patients likely to exhibit aggressive behavior self according to the judgment of the investigators.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Chu Le Vinatier
Bron, 69500
Thierry DAMATO, MD
Frédéric HAESEBAERT, PHD
- Not yet recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Isabelle CHEREAU, MD
Pierre-Michel LLORCA, MD
- Not yet recruiting
Chu Grenoble
Grenoble, 38000
Mircea POLOSAN, MD
Arnaud POUCHON, MD
- Not yet recruiting
HÔPITAL Edouard Herriot
Lyon, 69003
Emmanuel POULET, MD
Louis SIMON, MD
- Recruiting
Chu Saint Etienne
Saint-Etienne, 42100
Eric FAKRA, MD PhD
Maxence RIGON, MD
About this study
Official title: Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.
Read the detailed description
Recently, radiological markers demonstrated a good capacity to discriminate first episode of psychosis patients, that will show a bad response to treatment. Furthermore, automatic learning methods were recently successfully applied to neurological data, but never for the first episode psychosis patients. These powerful methods are based on multivariate analyses allowing the prediction at an individual stage. The possibility to identify more precisely the population of non-answering patients would allow the adaptation of the support in first attention for these patients, and consequently to perform appropriate cares.
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.
- Conditions
- Schizophrenia
- Being tested
- MRI
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Also called Magnetic Resonance Imagery
Magnetic Resonance Imagery will be performed on patients attempted by schizophrenia. The aim of this intervention is an early detection of the non-answering patients to the primary cares.
| Study group | Role | What they receive |
|---|---|---|
| First episode of psychosis patients | Patients with schizophrenia will be studied in this clinical trial, and that have never received anti-psychotic treatment. They will perform an MRI. Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the predictive value of the imagery markers.
To evaluate the predictive value of imaging markers (morphological and structural connectivity imaging) for the absence of remission at 3 months in patients with PEP.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start11 Dec 2025
- Primary completionApr 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Eric FAKRA, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670447
- Sponsor's protocol ID
- 1508174
- Other IDs
- 2015-A01756-43
- Acronym
- PEPsy
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2016
- Last updated
- 22 Sep 2026
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study
- ClinicalTrials.gov ID
- NCT02670447
- Acronym / sponsor ID
- PEPsy / 1508174
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 1 Feb 2016 (estimated)
- 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.
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.
Detailed description
Recently, radiological markers demonstrated a good capacity to discriminate first episode of psychosis patients, that will show a bad response to treatment. Furthermore, automatic learning methods were recently successfully applied to neurological data, but never for the first episode psychosis patients. These powerful methods are based on multivariate analyses allowing the prediction at an individual stage. The possibility to identify more precisely the population of non-answering patients would allow the adaptation of the support in first attention for these patients, and consequently to perform appropriate cares.
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First episode of psychosis patients | – | Procedure: MRIPatients with schizophrenia will be studied in this clinical trial, and that have never received anti-psychotic treatment. They will perform an MRI. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients suffering of schizophrenia will be included in this study. They do not have ever taken anti-psychotic treatment.
Key inclusion criteria (8 listed)
- men and women aged 18-35 years
- member or beneficiary of a social security scheme,
- for women, appropriate contraception will be mandatory, as well as a negative pregnancy test,
- patients with a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to the DMS V
- having never received anti-psychotic treatment,
Key exclusion criteria (7 listed)
- Female patients of childbearing period without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
- Patients pregnant or nursing;
- Presenting a serious somatic or neurological disease, especially Parkinson's disease, epilepsy, debilitating tardive dyskinesia, cardiovascular disease, severe liver or kidney;
- Featuring against-indication for an MRI; including: metallic foreign body eye or intracranial, pacemaker, heart valve, surgical clips, claustrophobia, large tattoo in the upper part of the body, not compatible with 3T MRI
- Having a history of alcohol or drug abuse in the past year;
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 |
|---|---|---|
| MRIAlso: Magnetic Resonance ImageryMagnetic Resonance Imagery will be performed on patients attempted by schizophrenia. The aim of this intervention is an early detection of the non-answering patients to the primary cares. | Procedure or surgery | First episode of psychosis patients |
Primary outcome
Score of the predictive value of the imagery markers.
Time frame: Month 3
To evaluate the predictive value of imaging markers (morphological and structural connectivity imaging) for the absence of remission at 3 months in patients with PEP.
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 22 Sep 2026.
- 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Centre Hospitalier Universitaire de Saint Etienne at 5 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 8 inclusion and 7 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Score of the predictive value of the imagery markers. (time frame: Month 3). 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 22 Sep 2026.