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Biocollection on Peripheral Inflammation

Study acronym: IBIS-PSY
StatusRecruiting
PhaseNot specified
Started2024-03-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 19 months later Aug 2, 2026 → Mar 19, 2028
Enrollment reduced 83% 300 → 50 participants
See other at-risk trials from Nantes University Hospital

Amendment history

2026-07-28
Study Status, Study Design v7
Enrollment reduced: 300 → 50 participants
Primary completion pushed: 2026-08-02 → 2028-03-19
Completion pushed: 2028-02-02 → 2028-03-19
2024-04-05
Study Status v6
Start dateestimated 2024-04-02→confirmed 2024-03-19
2024-03-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-06-02→2026-08-02
Completion date2027-12-02→2028-02-02
Start date2024-02-02→2024-04-02
Study sitesdetails revised at 1 of 1 site
2023-12-21
Study Status, Arms and Interventions, Eligibility v4
Primary completion date2026-04-02→2026-06-02
Completion date2027-10-02→2027-12-02
Start date2023-10-02→2024-02-02
Eligibility criteria+32 characters
[...] atient under psychiatric care at Nantes University Hospital Patients weighing at least 45kg Patient affiliated to a social security scheme or beneficiar [...]
2023-09-04
Study Status v3
Re-verified, no change to tracked fields
Show 2 earlier versions
2023-08-03
Study Status, Outcome Measures, Contacts/Locations v2
Study sites0→1
Secondary endpoints+368 characters
Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS)) Comparison of biomarkers between different psychiatric illnesses in order to develop models based [...]
2023-07-11
Study Status, Study Description v1
Re-verified, no change to tracked fields
2023-06-28
Original filing
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.
Trial Details
NCT Number NCT05934474
Lead Sponsor Nantes University Hospital
Collaborators: CR2TI, INSERM, UMR1064
Conditions Schizoaffective Disorder, Depressive Type, Bipolar Disorder I, Bipolar Disorder II
Enrollment 50 participants
Start Date 2024-03-19
Primary Completion 2028-03-19 (estimated)
Study Completion 2028-03-19 (estimated)
Updated on ClinicalTrials.gov 2026-07-29