Clinical trial NCT06968598: Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
Official title: Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bipolar Disorder (BD)
Organoids
Neurodevelopmental Conditions
Keywords: organoid
neurodevelopmental alterations
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: 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.
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
measure: Establish induced pluripotent stem cell (iPSC) lines from cryopreserved PBMCs of the TB-ND subgroup
timeFrame: Through study completion, an average of 2 year
measure: Quality of cortical organoids produced from these iPSCs
timeFrame: Through study completion, an average of 2 year
measure: Assessing the reproducibility of the iPSC derivation protocol in cortical organoids
timeFrame: Through study completion, an average of 2 year
Other outcomes:
Locations:
Study officials:
affiliation: Director of the AP-HM
name: François CREMIEUX
role: STUDY_DIRECTOR
References: