Biocollection on Peripheral Inflammation

Bipolar Disorder I Clinical Trial

— IBIS-PSY  

Official title:

Biocollection on Peripheral Inflammation in Psychiatric Pathologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934474
• Other study ID #: RC23_0270
• Status: Recruiting
• Start date: March 19, 2024
• Est. completion date: February 2, 2028

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Anne Sauvaget
• Phone: +33 240084795
• Email: anne.sauvaget[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2, 2028
• Est. primary completion date: August 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder I
• Bipolar Disorder II
• Depression
• Depressive Disorder
• Inflammation
• Psychotic Disorders
• Schizoaffective Disorder, Depressive Type

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	CR2TI, INSERM, UMR1064

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms		2 hours
Secondary	Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS))		2 hours
Secondary	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