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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Procedure: MRI

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Carine LABRUYERE, CRA; Phone Number: +33 (0)477124069; Email: carine.labruyere@chu-st-etienne.fr
• Study Contact Backup: Name: Eric FAKRA, MD PhD; Phone Number: +33 (0)477127885; Email: eric.fakra@chu-st-etienne.fr

Study Locations

• France
  • Bron, France, 69500
    • Chu Le Vinatier
    • Sub-Investigator: Thierry DAMATO, MD
    • Sub-Investigator: Frédéric HAESEBAERT, MD
    • Principal Investigator: Romain REY, MD
  • Clermont-Ferrand, France, 63003
    • CHU clermont-ferrand
    • Sub-Investigator: Isabelle CHEREAU, MD
    • Principal Investigator: Pierre-Michel LLORCA, MD
  • Grenoble, France, 38000
    • CHU Grenoble
    • Principal Investigator: Mircea POLOSAN, MD
    • Sub-Investigator: Clément DONDE-COQUELET, MD
    • Sub-Investigator: Arnaud POUCHON, MD
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
    • Principal Investigator: Louis SIMON, MD
    • Sub-Investigator: Emmanuel POULET, MD
  • Saint-Étienne, France, 42100
    • CHU Saint Etienne
    • Principal Investigator: Maël PULCINI, MD
    • Sub-Investigator: Christophe GAULD, MD
    • Principal Investigator: Eric FAKRA, MD PhD
    • Sub-Investigator: Maxence RIGON, MD
    • Sub-Investigator: Colas MOREL-PRIEUR, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suffering of schizophrenia will be included in this study. They do not have ever taken anti-psychotic treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: MRI; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the predictive value of the imagery markers.	Evaluate the predictive value for the imagery markers on the therapeutic non-answer at month 3 for patients presenting a first psychotic episode.	Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Eric FAKRA, MD PhD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimated): February 1, 2016

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 1508174; 2015-A01756-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No