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Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies

Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02670447
Acronym
PEPsy
Enrollment
80
Registered
2016-02-01
Start date
2025-12-11
Completion date
2031-04-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief 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. 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.

Interventions

PROCEDUREMRI

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.

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Score of the predictive value of the imagery markers.Month 3Evaluate the predictive value for the imagery markers on the therapeutic non-answer at month 3 for patients presenting a first psychotic episode.

Countries

France

Contacts

Primary ContactEric FAKRA, MD PhD
eric.fakra@chu-st-etienne.fr(0)477127885
Backup ContactMarlène BONNEFOI, Project manager
marlene.bonnefoi@chu-st-etienne.fr(0)477120826

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026