Patientheque in Patients With a Psychosis . (LONGIPEP)

Formation of a Patientheque in Patients With a Beginner Psychosis .

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizophrenia Prodromal; Schizophrenia, Childhood
• Intervention / Treatment: Other: Blood samples (36 mL) + fecal samples + hair sample

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michel WALTER; Phone Number: +332 98 01 51 56; Email: michel.walter@chu-brest.fr
• Study Contact Backup: Name: Christophe LEMEY; Phone Number: +336 19 21 10 32; Email: christophe.lemey@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU Brest
    • Contact: Christophe LEMEY; Phone Number: 06 19 21 10 32; Email: christophe.lemey@chu-brest.fr
    • Contact: Michel WALTER; Phone Number: 06 42 30 58 48; Email: michel.walter@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient library; All the patients are included in one arm. They will undergo various type of samples.	Other: 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; Other Names: Patient library

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAARMS (Comprehensive assessment of at-risk mental states) score.	The test will determine the mental state of the patient : "Not at risk of psychosis"; "At risk of psychosis"; "Psychosis threshold exceeded" It is organized into 7 clinical dimensions: 1) positive symptoms 2) cognitive changes: attention / concentration 3) emotional disturbance 4) negative symptoms 5) behavioral change 6) physical and motor changes 7) general psychopathology. Each category is scored between 0 and 6 depending on the level of intensity, frequency and duration of each symptom. In order to determine if a subject meets the UHR criteria for CAARMS, only the first category (positive symptoms) and its four subscales are used according to a scoring algorithm.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAARMS sub-assemblies	If the patient is classified at risk of psychosis, the test will classify this risk into one of the three following categories : trait and state risk factor group, APS (attenuated psychotic symptoms) group, BLIPS (Brief, Limited or Intermittent Psychotic Symptoms) group.	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Michel WALTER, CHRU Brest

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Anticipated): July 25, 2027
• Study Completion (Anticipated): July 25, 2032

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Patient library
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurodevelopmental Disorders; Schizophrenia; Schizophrenia, Childhood
• Other Study ID Numbers: 29BRC20.0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital (UH). Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

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