Patientheque in Patients With a Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-30
SponsorUniversity Hospital, Brest
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Blood samples (36 mL) + fecal samples + hair sample
Other interventionBlood samples at inclusion, 2 years later and/or if relapse, fecal samples at inclusion and every years for 5 years, hair sample at inclusion
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Patient libraryOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 yearsSecondary outcomes
1
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov