LONGIPEP: Patientheque in Patients With a Psychosis .

Sponsor

University Hospital, Brest (Other)

Overall Status

Recruiting

CT.gov ID

NCT05340348

Collaborator

(none)

250

Enrollment

Location

Arm

120

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Prodromal Schizophrenia, Childhood Schizophrenia	Other: Blood samples (36 mL) + fecal samples + hair sample	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Monocentric interventional study with minimal risks and constraintsMonocentric interventional study with minimal risks and constraints

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Formation of a Patientheque in Patients With a Beginner Psychosis .

Actual Study Start Date :

Jul 25, 2022

Anticipated Primary Completion Date :

Jul 25, 2027

Anticipated Study Completion Date :

Jul 25, 2032

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
The MINI (Mini International Neuropsychiatric Interview) [5 years]
It is used to diagnose the main psychiatric disorders. The MINI makes it possible to determine a current and/or lifetime prevalence of the various disorders explored

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

Principal Investigator: Michel WALTER, CHRU BREST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT05340348

Other Study ID Numbers:

29BRC20.0097

First Posted:

Apr 22, 2022

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Brest

Schizophrenia

Patient library

Additional relevant MeSH terms:

Schizophrenia

Schizophrenia, Childhood

Study Results

No Results Posted as of Jul 27, 2022