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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05340348
Other study ID # 29BRC20.0097
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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