Patientheque in Patients With a Psychosis .

NCT ID: NCT05340348

Last Updated: 2025-02-04

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

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2032-07-25

Brief Summary

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Establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.

Detailed Description

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The constitution of this patient library will include results of clinical tests carried out in current practice, neurocognitive tests, blood samples, audio recordings, clinical follow-up, urine samples, fecal samples, brain imaging, EEG.

Conditions

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Schizophrenia Prodromal Schizophrenia, Childhood Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Monocentric interventional study with minimal risks and constraints
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patient library

All the patients are included in one arm. They will undergo various type of samples.

Group Type OTHER

Blood samples (36 mL) + fecal samples + hair sample

Intervention Type OTHER

Blood samples at inclusion, 2 years later and/or if relapse, fecal samples at inclusion and every years for 5 years, hair sample at inclusion

Interventions

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Blood samples (36 mL) + fecal samples + hair sample

Blood samples at inclusion, 2 years later and/or if relapse, fecal samples at inclusion and every years for 5 years, hair sample at inclusion

Intervention Type OTHER

Other Intervention Names

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Patient library

Eligibility Criteria

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Inclusion Criteria

* Major and or minor aged 15 to 30 assessed within the CEVUP (Consultation for the Assessment of Psychological Vulnerability) and cared for at the psychiatry center as part of a first psychotic episode (Diagnosis CIM 10: F20 -F29 first hospitalization). These patients are referred by care and medico-social partners (general practitioners, school doctors, school nurses, educators, addictologists, psychiatrists
* "At risk" status for psychotic disorder (GRD, APS, BLIPS group) or psychosis threshold during the CAARMS test (psychometric scale for the assessment of psychotic symptoms)
* Consent of the patient or his legal guardian

Exclusion Criteria

* History of psychosis for more than one year
* "Not at risk" status for psychotic disorder on the CAARMS (psychometric scale for the assessment of psychotic symptomatology)
* IQ\<70 (WAIS)
* Neurological disorder or other health problem that may explain the disorders
* Refusal to participate - History of psychosis for more than one year
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel WALTER

Role: PRINCIPAL_INVESTIGATOR

CHRU BREST

Locations

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Chu Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Michel WALTER

Role: CONTACT

+332 98 01 51 56

Christophe LEMEY

Role: CONTACT

+336 19 21 10 32

Facility Contacts

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Christophe LEMEY

Role: primary

06 19 21 10 32

Michel WALTER

Role: backup

06 42 30 58 48

Other Identifiers

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29BRC20.0097

Identifier Type: -

Identifier Source: org_study_id

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