Health TrialsbyHealthPanel

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

ConditionsBipolar Disorder (BD)OrganoidsNeurodevelopmental Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

- 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

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sample

    Other intervention

    blood sample

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Neurodevelopmental alterationExperimental treatment 1 intervention
Group B: No Neurodevelopmental alterationPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
Through study completion, an average of 2 year

Secondary outcomes

1

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

Pluripotency

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

Quality of cortical organoids produced from these iPSCs

Viability of organoids

Time frame
Through study completion, an average of 2 year
3

Assessing the reproducibility of the iPSC derivation protocol in cortical organoids

Reproducibility of the cortical organoid differentiation protocol

Time frame
Through study completion, an average of 2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique Hopitaux De Marseille

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: