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

NCT06968598 | Not Yet Recruiting

• 1 other identifier: 2024-A02158-39
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder (BD); Organoids; Neurodevelopmental Conditions

Keywords

organoid; neurodevelopmental alterations

Outcome Measures

Primary Outcomes (1)

• 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.

  Organization of cortical layers in both subgroups

  Through study completion, an average of 2 year

Secondary Outcomes (3)

• Establish induced pluripotent stem cell (iPSC) lines from cryopreserved PBMCs of the TB-ND subgroup

  Through study completion, an average of 2 year

• Quality of cortical organoids produced from these iPSCs

  Through study completion, an average of 2 year

• Assessing the reproducibility of the iPSC derivation protocol in cortical organoids

  Through study completion, an average of 2 year

Study Arms (2)

Neurodevelopmental alteration

EXPERIMENTAL

blood sampling to generate organoids in the ND group

Other: blood sample

No Neurodevelopmental alteration

PLACEBO COMPARATOR

blood sampling to generate organoids in the non- ND group

Other: blood sample

Interventions

blood sample OTHER

blood sample

Neurodevelopmental alteration; No Neurodevelopmental alteration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François CREMIEUX

  Director of the AP-HM

  STUDY DIRECTOR

Central Study Contacts

Antoine LEFRERE

CONTACT

+33491744013; antoine.lefrere@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: May 13, 2025

Record last verified: 2025-05