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NCT06968598Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
19 Dec 2024
Start date
1 Jun 2025
Primary completion date
1 Feb 2030
Lead sponsor
Assistance Publique Hopitaux De Marseille
NCT number
NCT06968598

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 1 Jun 2025 to the primary completion date, 1 Feb 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • \- 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.

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.