Bipolar Disorder (BD), Neurodevelopmental Conditions, Organoids
Conditions
Keywords
organoid, neurodevelopmental alterations
Brief summary
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.
Interventions
OTHERblood sample
blood sample
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Presence of bipolar disorder according to DSM-5 criteria * Able to freely give and sign consent * Affiliated or beneficiary of a health insurance plan * Previous participants in the NEMO study (2022-A00353-40) 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
* \- Presence of a severe symptomatic or unstable physiological or medical condition (including pregnancy) * History of psychiatric illness (stable or not), schizophrenia or any other pathology likely to interfere with bipolar disorder * History of severe head trauma (GCS\<8 at time of trauma) * Presence of a neurological disorder affecting central nervous system function * Presence of moderate to severe substance use disorders (\>=4/11 as defined in DSM-5), with the exception of tobacco use disorders. * The volunteer is under court protection or guardianship * It proves impossible to give the volunteer informed information, or the volunteer refuses to sign the consent form. * Insufficient command of the French language to complete evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Through study completion, an average of 2 year | Organization of cortical layers in both subgroups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establish induced pluripotent stem cell (iPSC) lines from cryopreserved PBMCs of the TB-ND subgroup | Through study completion, an average of 2 year | Pluripotency |
| Quality of cortical organoids produced from these iPSCs | Through study completion, an average of 2 year | Viability of organoids |
| Assessing the reproducibility of the iPSC derivation protocol in cortical organoids | Through study completion, an average of 2 year | Reproducibility of the cortical organoid differentiation protocol |
Contacts
Primary ContactAntoine LEFRERE
Outcome results
None listed