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NCT Number: NCT05340348

Patientheque in Patients With a Psychosis

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.

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Key information

Conditions

Schizophrenia Prodromal Mental Disorders Neurodevelopmental Disorders Personality Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Childhood Schizotypal Personality Disorder

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples (36 mL) + fecal samples + hair sample

Other

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

Other names: Patient library

Primary outcomes

  1. CAARMS (Comprehensive assessment of at-risk mental states) score.

    Time frame: 5 years

    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 outcomes

  1. CAARMS sub-assemblies

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe LEMEY

CONTACT

[email protected]

+336 19 21 10 32

Michel WALTER

CONTACT

[email protected]

+332 98 01 51 56

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Formation of a Patientheque in Patients With a Beginner Psychosis

Acronym: LONGIPEP

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Apr 22, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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