Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models

Not Applicable

Not yet recruiting

• Conditions: Bipolar Disorder (BD); Organoids; Neurodevelopmental Conditions

• Registration Number: NCT06968598
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-19
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-06-01
• Primary Completion: 2030-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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