Patientheque in Patients With a Psychosis .

Not Applicable

Recruiting

• Conditions: Schizophrenia; Schizophrenia Prodromal; Schizophrenia, Childhood
• Interventions: Other: Blood samples (36 mL) + fecal samples + hair sample

• Registration Number: NCT05340348
• Lead Sponsor: University Hospital, Brest

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.

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 Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-22
• Study Start: 2022-07-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2027-07-25
• Study Completion: 2032-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient library	Blood samples (36 mL) + fecal samples + hair sample	All the patients are included in one arm. They will undergo various type of samples.

Primary Outcome Measures

Name	Time	Method
CAARMS (Comprehensive assessment of at-risk mental states) score.	5 years	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.

Secondary Outcome Measures

Name	Time	Method
CAARMS sub-assemblies	5 years	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.

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France