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Biocollection on Peripheral Inflammation

Biocollection on Peripheral Inflammation in Psychiatric Pathologies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05934474
Acronym
IBIS-PSY
Enrollment
50
Registered
2023-07-07
Start date
2024-03-19
Completion date
2028-03-19
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder I, Bipolar Disorder II, Schizoaffective Disorder, Depressive Type

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.

Interventions

BIOLOGICALPeripheral venipuncture blood sampling, as part of standard care procedures

Collection of 36 mL of blood

OTHERInterview with a psychiatrist

Research project data collection

Sponsors

Nantes University Hospital
Lead SponsorOTHER
CR2TI, INSERM, UMR1064
CollaboratorUNKNOWN

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders.2 hoursBiological analysis of IBIS-PSY biocollection samples

Secondary

MeasureTime frame
Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms2 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 diagnosis2 hours

Countries

France

Contacts

CONTACTAnne Sauvaget
anne.sauvaget@chu-nantes.fr+33 240084795
PRINCIPAL_INVESTIGATORAnne Sauvaget

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026