Status:
NOT_YET_RECRUITING
Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Bipolar Disorder (BD)
Organoids
Eligibility:
All Genders
18-60 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06968598
Start Date
June 1 2025
End Date
February 1 2030
Last Update
May 13 2025
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