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

Schizophrenia Clinical Trial

— PEPsy  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02670447
• Other study ID #: 1508174
• Secondary ID: 2015-A01756-43
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: August 2030

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Eric FAKRA, MD PhD
• Phone: (0)477127885
• Email: eric.fakra[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The link between evolution of these markers and clinical measures will be studied.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2030
• Est. primary completion date: August 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
France	Chu Le Vinatier	Bron
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	Chu Grenoble	Grenoble
France	HÔPITAL Edouard Herriot	Lyon
France	Chu Saint Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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