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

NCT ID: NCT02670447

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-11

Study Completion Date

2031-04-30

Brief Summary

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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

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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

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Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Magnetic Resonance Imagery

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric FAKRA, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Le Vinatier

Bron, , France

Site Status NOT_YET_RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Chu Grenoble

Grenoble, , France

Site Status NOT_YET_RECRUITING

HÔPITAL Edouard Herriot

Lyon, , France

Site Status NOT_YET_RECRUITING

Chu Saint Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eric FAKRA, MD PhD

Role: CONTACT

Phone: (0)477127885

Email: [email protected]

Marlène BONNEFOI, Project manager

Role: CONTACT

Phone: (0)477120826

Email: [email protected]

Other Identifiers

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2015-A01756-43

Identifier Type: OTHER

Identifier Source: secondary_id

1508174

Identifier Type: -

Identifier Source: org_study_id