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Demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder (BD) with a neurodevelopmental (ND) component, compared with patients with bipolar disorder (BD) without an ND component.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurodevelopmental alteration | Experimental | blood sampling to generate organoids in the ND group |
|
| No Neurodevelopmental alteration | Placebo Comparator | blood sampling to generate organoids in the non- ND group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Other | blood sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder with a neurodevelopmental (ND) component, compared with patients with bipolar disorder without ND component. | Organization of cortical layers in both subgroups | Through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Establish induced pluripotent stem cell (iPSC) lines from cryopreserved PBMCs of the TB-ND subgroup | Pluripotency | Through study completion, an average of 2 year |
| Quality of cortical organoids produced from these iPSCs |
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Inclusion Criteria:
For the "neurodevelopmental bipolar" (ND-BP) group: presence of a neurodevelopmental burden score in the top 5, as assessed in the NEMO project (NCT05674019).
For the "non-neurodevelopmental bipolar" group (TB): presence of a neurodevelopmental load score of 0, or in the lowest 5, as assessed in the NEMO project.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine LEFRERE | Contact | +33491744013 | antoine.lefrere@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX | Director of the AP-HM | Study Director |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Viability of organoids
| Through study completion, an average of 2 year |
| Assessing the reproducibility of the iPSC derivation protocol in cortical organoids | Reproducibility of the cortical organoid differentiation protocol | Through study completion, an average of 2 year |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |