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Patientheque in Patients With a Psychosis . (LONGIPEP)

Primary Purpose

Schizophrenia Prodromal, Schizophrenia, Childhood, Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples (36 mL) + fecal samples + hair sample
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia Prodromal focused on measuring Schizophrenia, Patient library

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu BrestRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient library

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 8, 2022
Last Updated
January 16, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT05340348
Brief Title
Patientheque in Patients With a Psychosis .
Acronym
LONGIPEP
Official Title
Formation of a Patientheque in Patients With a Beginner Psychosis .
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
July 25, 2027 (Anticipated)
Study Completion Date
July 25, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Prodromal, Schizophrenia, Childhood, Schizophrenia
Keywords
Schizophrenia, Patient library

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric interventional study with minimal risks and constraints
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient library
Arm Type
Other
Arm Description
All the patients are included in one arm. They will undergo various type of samples.
Intervention Type
Other
Intervention Name(s)
Blood samples (36 mL) + fecal samples + hair sample
Other Intervention Name(s)
Patient library
Intervention Description
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
Primary Outcome Measure Information:
Title
CAARMS (Comprehensive assessment of at-risk mental states) score.
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
CAARMS sub-assemblies
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel WALTER
Phone
+332 98 01 51 56
Email
michel.walter@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe LEMEY
Phone
+336 19 21 10 32
Email
christophe.lemey@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel WALTER
Organizational Affiliation
CHRU BREST
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe LEMEY
Phone
06 19 21 10 32
Email
christophe.lemey@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Michel WALTER
Phone
06 42 30 58 48
Email
michel.walter@chu-brest.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Patientheque in Patients With a Psychosis .

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