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Recruiting NCT05340348

Patientheque in Patients With a Psychosis

No phase Interventional Schizophrenia Prodromal Schizophrenia, Childhood Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples (36 mL) + fecal samples + hair sample.
Who it may be relevant to
Registry conditions: Schizophrenia Prodromal, Schizophrenia, Childhood, Schizophrenia. Basic parameters: 15 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Formation of a Patientheque in Patients With a Beginner Psychosis

Overview

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

  • 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

Primary outcome measures

  • CAARMS (Comprehensive assessment of at-risk mental states) score. [Time frame: 5 years]
Secondary outcome measures (1)
  • CAARMS sub-assemblies [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Chu Brest — Brest

Identifiers

NCT: NCT05340348 · 29BRC20.0097

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗