Biocollection on Peripheral Inflammation

NCT05934474 | Recruiting

• 1 other identifier: RC23_0270
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

IBIS-PSY patients

Biological: Peripheral venipuncture blood sampling, as part of standard care procedures; Other: Interview with a psychiatrist

Interventions

Peripheral venipuncture blood sampling, as part of standard care procedures BIOLOGICAL

Collection of 36 mL of blood

IBIS-PSY patients

Interview with a psychiatrist OTHER

Research project data collection

IBIS-PSY patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• CR2TI, INSERM, UMR1064: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, 44100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sampling

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne Sauvaget

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Sauvaget

CONTACT

+33 240084795; anne.sauvaget@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: March 19, 2024
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): February 2, 2028
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)