Biocollection on Peripheral Inflammation

Recruiting

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

• Registration Number: NCT05934474
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-07
• Study Start: 2024-03-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2026-08-02
• Study Completion: 2028-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBIS-PSY patients	Peripheral venipuncture blood sampling, as part of standard care procedures	-
IBIS-PSY patients	Interview with a psychiatrist	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France