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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

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

Treatments: Other: blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT06968598

2024-A02158-39

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Neurodevelopmental alteration

Experimental group

Description:

blood sampling to generate organoids in the ND group

Treatment:

Other: blood sample

No Neurodevelopmental alteration

Placebo Comparator group

Description:

blood sampling to generate organoids in the non- ND group

Treatment:

Other: blood sample