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NCT Number: NCT06968598

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

blood sample

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.

    Time frame: Through study completion, an average of 2 year

    Organization of cortical layers in both subgroups

Secondary outcomes

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

    Time frame: Through study completion, an average of 2 year

    Pluripotency

  2. Quality of cortical organoids produced from these iPSCs

    Time frame: Through study completion, an average of 2 year

    Viability of organoids

  3. Assessing the reproducibility of the iPSC derivation protocol in cortical organoids

    Time frame: Through study completion, an average of 2 year

    Reproducibility of the cortical organoid differentiation protocol

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine LEFRERE

CONTACT

[email protected]

+33491744013

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: BIPODEV

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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