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NCT Number: NCT02670447

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Le Vinatier, Bron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Procedure

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.

Other names: Magnetic Resonance Imagery

Primary outcomes

  1. Score of the predictive value of the imagery markers.

    Time frame: Month 3

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

Study contacts

Contact information is provided by the study sponsor or research team.

Eric FAKRA, MD PhD

CONTACT

[email protected]

(0)477127885 ext. +33

Marlène BONNEFOI, Project manager

CONTACT

[email protected]

(0)477120826 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: PEPsy

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Feb 1, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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