Biocollection on Peripheral Inflammation (IBIS-PSY)

Biocollection on Peripheral Inflammation in Psychiatric Pathologies

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder I; Bipolar Disorder II; Schizoaffective Disorder, Depressive Type
• Intervention / Treatment: Other: Interview with a psychiatrist; Biological: Peripheral venipuncture blood sampling, as part of standard care procedures

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Anne Sauvaget; Phone Number: +33 240084795; Email: anne.sauvaget@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44100
    • Recruiting
    • Nantes University Hospital
    • Contact: Anne Sauvaget, MD; Phone Number: +33 2 40 08 47 95; Email: anne.sauvaget@chu-nantes.fr
    • Principal Investigator: Anne Sauvaget, MD
    • Sub-Investigator: Jean-Baptiste GUINÉ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBIS-PSY patients	Other: Interview with a psychiatrist; Research project data collection; Biological: Peripheral venipuncture blood sampling, as part of standard care procedures; Collection of 36 mL of blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders.	Biological analysis of IBIS-PSY biocollection samples	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms	2 hours
Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS))	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	2 hours

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: CR2TI, INSERM, UMR1064
• Investigators: Principal Investigator: Anne Sauvaget, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): February 2, 2028

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Psychotic Disorders; Inflammation; Bipolar Disorder
• Other Study ID Numbers: RC23_0270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No