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

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ClinicalTrials.gov Identifier: NCT02670447
Recruitment Status : Not yet recruiting
First Posted : February 1, 2016
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment
Schizophrenia 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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 Name: Magnetic Resonance Imagery




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood samples will be taken for every patient to make toxicological tests.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670447


Contacts
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Contact: Eric FAKRA, MD PhD (0)477127885 ext +33 eric.fakra@chu-st-etienne.fr
Contact: DEYGAS Béatrice, CRA (0)477827655 ext +33 beatrice.deygas@chu-st-etienne.fr

Locations
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France
Chu Le Vinatier
Bron, France, 69500
Contact: Thierry DAMATO, MD    0437915555      
Principal Investigator: Thierry DAMATO, MD         
Sub-Investigator: Frédéric HAESEBAERT, MD         
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Contact: Isabelle CHEREAU, MD         
Principal Investigator: Isabelle CHEREAU, MD         
Sub-Investigator: Pierre-Michel LLORCA, MD         
Chu Grenoble
Grenoble, France, 38000
Contact: Claire BUIS, MD         
Principal Investigator: Claire BUIS, MD         
Sub-Investigator: Mircea POLOSAN, MD         
Hopital E. Herriot
Lyon, France, 69003
Contact: Emmanuel POULET, MD         
Principal Investigator: Emmanuel POULET, MD         
Chu Saint Etienne
St Etienne, France, 42100
Contact: Aïda CANCEL, MD         
Sub-Investigator: Thierry BASSET, MD         
Sub-Investigator: Claire BOUTET, MD         
Principal Investigator: Eric FAKRA, MD         
Sub-Investigator: Catherine MASSOUBRE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Eric FAKRA, MD PhD CHU SAINT ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02670447    
Other Study ID Numbers: 1508174
2015-A01756-43 ( Other Identifier: ANSM )
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders