Schizoaffective Disorder, Depressive TypeIBIS-PSYNCT05934474
Biocollection on Peripheral Inflammation
An observational study of Schizoaffective Disorder, Depressive Type and Bipolar Disorder I, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizoaffective Disorder, Depressive Type, Bipolar Disorder I, Bipolar Disorder II
- What is being tested?
- Interview with a psychiatrist
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 19 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44100
Anne Sauvaget, MD, +33 2 40 08 47 95, anne.sauvaget@chu-nantes.fr
Anne Sauvaget, MD
About this study
Official title: Biocollection on Peripheral Inflammation in Psychiatric Pathologies
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.
- Being tested
- Peripheral venipuncture blood sampling, as part of standard care procedures, Interview with a psychiatrist
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral venipuncture blood sampling, as part of standard care proceduresBiological
Collection of 36 mL of blood
Interview with a psychiatristOther
Research project data collection
| Study group | Role | What they receive |
|---|---|---|
| IBIS-PSY patients | Not described Receives: Biological: Peripheral venipuncture blood sampling, as part of standard care procedures; Other: Interview with a psychiatrist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders.
Biological analysis of IBIS-PSY biocollection samples
Measured: 2 hours
Secondary outcomes (3)
Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms
Measured: 2 hours
Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS))
Measured: 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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start19 Mar 2024
- Primary completion19 Mar 2028 (estimated)
- Study completion19 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizoaffective Disorder, Depressive TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CR2TI, INSERM, UMR1064
- Responsible party
- Sponsor
- Investigators
- Anne Sauvaget, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934474
- Sponsor's protocol ID
- RC23_0270
- Acronym
- IBIS-PSY
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biocollection on Peripheral Inflammation in Psychiatric Pathologies
- ClinicalTrials.gov ID
- NCT05934474
- Acronym / sponsor ID
- IBIS-PSY / RC23_0270
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- CR2TI, INSERM, UMR1064
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 19 Mar 2028 (estimated)
- Study completion
- 19 Mar 2028 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBIS-PSY patients | – | Biological: Peripheral venipuncture blood sampling, as part of standard care procedures, Other: Interview with a psychiatrist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Major patient
- Patient with one of the following diagnoses confirmed by a psychiatrist:
- 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
Key exclusion criteria (8 listed)
- Pregnant,
- History of cancer in the last 5 years,
- Vaccination within the last 4 weeks,
- Acute or chronic infection,
- Medical history of organ transplant,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral venipuncture blood sampling, as part of standard care proceduresCollection of 36 mL of blood | Biological | IBIS-PSY patients |
| Interview with a psychiatristResearch project data collection | Other | IBIS-PSY patients |
Primary outcome
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
3 secondary outcomes
Validation of a patient clustering method separating patients with severe symptoms from those with mild symptoms
Time frame: 2 hours
Replication of a pan-transcriptomic study (A Transcriptome-Wide Association Study (TWAS))
Time frame: 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
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Sauvaget principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizoaffective Disorder, Depressive Type and Bipolar Disorder I, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Sauvaget (+33 240084795, anne.sauvaget@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of the presence of diagnostic biomarkers and biomarkers of severity common to several psychiatric disorders. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.