Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sample.
- Who it may be relevant to
- Registry conditions: Bipolar Disorder (BD), Organoids, Neurodevelopmental Conditions. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other blood sample
blood sample
Primary outcome measures
- 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. [Time frame: Through study completion, an average of 2 year]
Secondary outcome measures (3)
- Establish induced pluripotent stem cell (iPSC) lines from cryopreserved PBMCs of the TB-ND subgroup [Time frame: Through study completion, an average of 2 year]
- Quality of cortical organoids produced from these iPSCs [Time frame: Through study completion, an average of 2 year]
- Assessing the reproducibility of the iPSC derivation protocol in cortical organoids [Time frame: Through study completion, an average of 2 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06968598 · 2024-A02158-39