Patientheque in Patients With a Psychosis .

NCT05340348 | Recruiting

• 1 other identifier: 29BRC20.0097
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia Prodromal; Schizophrenia, Childhood; Schizophrenia

Keywords

Schizophrenia; Patient library

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CAARMS sub-assemblies

  5 years

Study Arms (1)

Patient library

OTHER

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

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

Interventions

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

Also known as: Patient library

Patient library

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Schizotypal Personality Disorder; Schizophrenia, Childhood; Schizophrenia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Neurodevelopmental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michel WALTER

  CHRU BREST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel WALTER

CONTACT

+332 98 01 51 56; michel.walter@chu-brest.fr

Christophe LEMEY

CONTACT

+336 19 21 10 32; christophe.lemey@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric interventional study with minimal risks and constraints

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 22, 2022
• Study Start: July 25, 2022
• Primary Completion (Estimated): July 25, 2027
• Study Completion (Estimated): July 25, 2032
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• 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.

Locations

FR (1)