IBIS-PSY: Biocollection on Peripheral Inflammation

Sponsor

Nantes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05934474

Collaborator

CR2TI, INSERM, UMR1064 (Other)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizoaffective Disorder, Depressive Type Bipolar Disorder I Bipolar Disorder II	Biological: Peripheral venipuncture blood sampling, as part of standard care procedures Other: Interview with a psychiatrist

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Biocollection on Peripheral Inflammation in Psychiatric Pathologies

Anticipated Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Apr 2, 2026

Anticipated Study Completion Date :

Oct 2, 2027

Arms and Interventions

Arm	Intervention/Treatment
IBIS-PSY patients	Biological: Peripheral venipuncture blood sampling, as part of standard care procedures Collection of 24 mL of blood Other: Interview with a psychiatrist Research project data collection

Arm

Intervention/Treatment

IBIS-PSY patients

Biological: Peripheral venipuncture blood sampling, as part of standard care procedures

Collection of 24 mL of blood

Other: Interview with a psychiatrist

Research project data collection

Outcome Measures

Primary Outcome Measures

Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders. [2 hours]
Biological analysis of IBIS-PSY biocollection samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nantes University Hospital
CR2TI, INSERM, UMR1064

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT05934474

Other Study ID Numbers:

RC23_0270

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2023