Patientheque in Patients With a Psychosis .

Study Overview
=================
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.

Official Title
-----------------
Formation of a Patientheque in Patients With a Beginner Psychosis .

Conditions
-----------------
Schizophrenia Prodromal, Schizophrenia, Childhood, Schizophrenia

Intervention / Treatment
-----------------
* Other: Blood samples (36 mL) + fecal samples + hair sample


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric interventional study with minimal risks and constraints
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient library<br>All the patients are included in one arm. They will undergo various type of samples. | Other: Blood samples (36 mL) + fecal samples + hair sample<br>* 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<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Patient library