Clinical trial NCT05934474: Biocollection on Peripheral Inflammation
Official title: Biocollection on Peripheral Inflammation in Psychiatric Pathologies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizoaffective Disorder, Depressive Type
Bipolar Disorder I
Bipolar Disorder II
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: CR2TI, INSERM, UMR1064
First posted: 2023-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited through the doctors who care for them on a regular medical basis, during a consultation or hospitalization in a psychiatric unit. After inclusion, an additional blood sample (4 tubes with a peripheral venous sample) will be taken by nurses from the psychiatric wards caring for the patient, during a blood sample taken as part of the patient's care. The sample will be transported to the Biological Resource Center (CRB) at Nantes University Hospital, where it will be stored along with all other study samples.

Brief summary: 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.


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

Primary outcomes:
measure: Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders.
timeFrame: 2 hours
Secondary outcomes:
measure: Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms
timeFrame: 2 hours
measure: Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS))
timeFrame: 2 hours
measure: Comparison of biomarkers between different psychiatric illnesses in order to develop models based on biological data that can help the physician adjust the diagnosis
timeFrame: 2 hours
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Anne Sauvaget
role: PRINCIPAL_INVESTIGATOR
References: