Biocollection on Peripheral Inflammation

NCT ID: NCT05934474

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-19

Study Completion Date

2028-02-02

Brief Summary

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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

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Conditions

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Schizoaffective Disorder, Depressive Type Bipolar Disorder I Bipolar Disorder II

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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IBIS-PSY patients

Peripheral venipuncture blood sampling, as part of standard care procedures

Intervention Type BIOLOGICAL

Collection of 36 mL of blood

Interview with a psychiatrist

Intervention Type OTHER

Research project data collection

Interventions

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Peripheral venipuncture blood sampling, as part of standard care procedures

Collection of 36 mL of blood

Intervention Type BIOLOGICAL

Interview with a psychiatrist

Research project data collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CR2TI, INSERM, UMR1064

UNKNOWN

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Sauvaget

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anne Sauvaget

Role: CONTACT

+33 240084795

Facility Contacts

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Anne Sauvaget, MD

Role: primary

+33 2 40 08 47 95

Other Identifiers

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RC23_0270

Identifier Type: -

Identifier Source: org_study_id

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