Biocollection on Peripheral Inflammation
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: Peripheral venipuncture blood sampling, as part of standard care procedures, Interview with a psychiatrist.
- Who it may be relevant to
- Registry conditions: Schizoaffective Disorder, Depressive Type, Bipolar Disorder I, Bipolar Disorder II. Basic parameters: from 18 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
Biocollection on Peripheral Inflammation in Psychiatric Pathologies
Overview
Most psychiatric research is based on the nosographic classifications used in current practice. At present, there is no diagnostic or prognostic biomarker for psychiatric pathologies commonly used in clinical practice. The study hypothesis is that peripheral inflammatory biomarkers could be common to several psychiatric disorders, in particular psychotic disorders (bipolar disorder, schizophreniform disorder, schizophrenia, depressive episode with psychotic features). The aim of this project is to set up a bio-collection of biological samples (peripheral blood samples) with associated phenotypic data (assessment of various symptoms using standardized scales in patients whose blood is sampled). The setting up of this cohort follows on from work carried out on a PsyCourse cohort also using a transdiagnostic approach in psychiatry, in order to be able to collaborate within a European research project.
Interventions
- Biological Peripheral venipuncture blood sampling, as part of standard care procedures
Collection of 36 mL of blood - Other Interview with a psychiatrist
Research project data collection
Primary outcome measures
- Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders. [Time frame: 2 hours]
Secondary outcome measures (3)
- Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms [Time frame: 2 hours]
- Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS)) [Time frame: 2 hours]
- Comparison of biomarkers between different psychiatric illnesses in order to develop models based on biological data that can help the physician adjust the diagnosis [Time frame: 2 hours]
Eligibility criteria
Inclusion criteria
- Major patient
- Patient with one of the following diagnoses confirmed by a psychiatrist:
- Characterized depressive episode with psychotic features,
- Bipolar disorder type I
- Bipolar disorder type II
- Schizoaffective disorder
- Schizophrenia
- Schizophreniform disorder
- Patient under psychiatric care at Nantes University Hospital
- Patients weighing at least 45kg
- Patient affiliated to a social security scheme or beneficiary of such a scheme
- Patient who has given informed consent to participate in the study
Exclusion criteria
- Pregnant,
- History of cancer in the last 5 years,
- Vaccination within the last 4 weeks,
- Acute or chronic infection,
- Medical history of organ transplant,
- Medical history of autoimmune disease,
- Hearing impairment making it impossible to complete study questionnaires,
- Patient under court protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Nantes University Hospital — Nantes
Identifiers
NCT: NCT05934474 · RC23_0270