Creating a patient library for individuals with psychosis
Formation of a Patientheque in Patients With a Beginner Psychosis .
NA · University Hospital, Brest · NCT05340348
This study is trying to create a helpful library of information for people who have had their first experience with psychosis to better understand how it develops and improve treatments over time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 15 Years to 30 Years |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 1 site (Brest) |
| Trial ID | NCT05340348 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a comprehensive patient library for individuals who have experienced their first psychotic episode and are identified as being at risk for developing a psychotic disorder. The library will include a variety of clinical data such as neurocognitive test results, blood and fecal samples, audio recordings, and brain imaging. Participants will be monitored over a period of 10 years, with samples collected at the time of inclusion, after two years, and in the event of relapse or significant clinical events. The goal is to better understand the progression of psychosis and improve future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 15 to 30 who have had a first psychotic episode and are assessed as being at risk for further psychotic disorders.
Not a fit: Patients with a history of psychosis lasting more than one year or those not classified as 'at risk' for psychotic disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of psychotic disorders, potentially enhancing treatment outcomes for patients.
How similar studies have performed: While the approach of creating a patient library for psychosis is innovative, similar studies focusing on early intervention and monitoring in psychotic disorders have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brest
- Chu Brest — Brest, France (RECRUITING)
Study contacts
- Principal investigator: Michel WALTER — CHRU BREST
- Study coordinator: Michel WALTER
- Email: michel.walter@chu-brest.fr
- Phone: +332 98 01 51 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia Prodromal, Schizophrenia, Childhood, Schizophrenia, Patient library