Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
NCT ID: NCT06968598
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-06-01
2030-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Neurodevelopmental alteration
blood sampling to generate organoids in the ND group
blood sample
blood sample
No Neurodevelopmental alteration
blood sampling to generate organoids in the non- ND group
blood sample
blood sample
Interventions
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blood sample
blood sample
Eligibility Criteria
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Inclusion 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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François CREMIEUX
Role: STUDY_DIRECTOR
Director of the AP-HM
Central Contacts
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Other Identifiers
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2024-A02158-39
Identifier Type: -
Identifier Source: org_study_id
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