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NCT Number: NCT05934474

Biocollection on Peripheral Inflammation

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.

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Key information

Conditions

Schizoaffective Disorder, Depressive Type Bipolar Disorder Bipolar Disorder I Bipolar Disorder II Bipolar and Related Disorders Mental Disorders Mood Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44100, France

Location status: Recruiting

Location contact

Anne Sauvaget, MD

CONTACT

[email protected]

+33 2 40 08 47 95

Anne Sauvaget, MD

PRINCIPAL_INVESTIGATOR

Jean-Baptiste GUINÉ

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral venipuncture blood sampling, as part of standard care procedures

Biological

Collection of 36 mL of blood

Interview with a psychiatrist

Other

Research project data collection

Primary outcomes

  1. Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders.

    Time frame: 2 hours

    Biological analysis of IBIS-PSY biocollection samples

Secondary outcomes

  1. Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms

    Time frame: 2 hours

  2. Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS))

    Time frame: 2 hours

  3. Comparison of biomarkers between different psychiatric illnesses in order to develop models based on biological data that can help the physician adjust the diagnosis

    Time frame: 2 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Sauvaget

CONTACT

[email protected]

+33 240084795

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • CR2TI, INSERM, UMR1064

Registry information

Official study title

Biocollection on Peripheral Inflammation in Psychiatric Pathologies

Acronym: IBIS-PSY

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 7, 2023
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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