Patientheque in Patients With a Psychosis .

Schizophrenia Clinical Trial

— LONGIPEP  

Official title:

Formation of a Patientheque in Patients With a Beginner Psychosis .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340348
• Other study ID #: 29BRC20.0097
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: July 25, 2032

Study information

• Verified date: July 2022
• Source: University Hospital, Brest
• Contact: Michel WALTER
• Phone: +332 98 01 51 56
• Email: michel.walter[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 25, 2032
• Est. primary completion date: July 25, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia Prodromal
• Schizophrenia, Childhood

Intervention

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

Locations

Country	Name	City	State
France	Chu Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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