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Patientheque in Patients With a Psychosis

Formation of a Patientheque in Patients With a Beginner Psychosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05340348
Acronym
LONGIPEP
Enrollment
250
Registered
2022-04-22
Start date
2022-07-25
Completion date
2032-07-25
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Schizophrenia, Childhood, Schizophrenia Prodromal

Keywords

Schizophrenia, Patient library

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.

Interventions

OTHERBlood 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

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Monocentric interventional study with minimal risks and constraints

Eligibility

Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CAARMS (Comprehensive assessment of at-risk mental states) score.5 yearsThe 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

MeasureTime frameDescription
CAARMS sub-assemblies5 yearsIf 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.

Countries

France

Contacts

CONTACTMichel WALTER
michel.walter@chu-brest.fr+332 98 01 51 56
CONTACTChristophe LEMEY
christophe.lemey@chu-brest.fr+336 19 21 10 32
PRINCIPAL_INVESTIGATORMichel WALTER

CHRU BREST

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026