Bipolar Disorder (BD)BIPODEVNCT06968598
Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
A study testing blood sample in people with Bipolar Disorder (BD) and Organoids, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder (BD), Organoids, Neurodevelopmental Conditions
- What is being tested?
- blood sample
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- blood sample
- Keywords
- organoid, neurodevelopmental alterations
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
blood sample
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental alteration | Experimental | blood sampling to generate organoids in the ND group Receives: Other: blood sample |
| No Neurodevelopmental alteration | Placebo comparator | blood sampling to generate organoids in the non- ND group Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Pluripotency
Measured: Through study completion, an average of 2 year
Quality of cortical organoids produced from these iPSCs
Viability of organoids
Measured: Through study completion, an average of 2 year
Assessing the reproducibility of the iPSC derivation protocol in cortical organoids
Reproducibility of the cortical organoid differentiation protocol
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Director of the AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968598
- Sponsor's protocol ID
- 2024-A02158-39
- Acronym
- BIPODEV
- Status last verified
- May 2025
- First submitted
- 19 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
- ClinicalTrials.gov ID
- NCT06968598
- Acronym / sponsor ID
- BIPODEV / 2024-A02158-39
- Keywords
- organoid, neurodevelopmental alterations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental alteration | Experimental | Other: blood sampleblood sampling to generate organoids in the ND group |
| No Neurodevelopmental alteration | Placebo comparator | Other: blood sampleblood sampling to generate organoids in the non- ND group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleblood sample | Other | Neurodevelopmental alteration, No Neurodevelopmental alteration |
Primary outcome
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
3 secondary outcomes
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
Quality of cortical organoids produced from these iPSCs
Time frame: Through study completion, an average of 2 year
Assessing the reproducibility of the iPSC derivation protocol in cortical organoids
Time frame: Through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Bipolar Disorder (BD)
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François CREMIEUX study director
Director of the AP-HM
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Bipolar Disorder (BD) and Organoids, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine LEFRERE (+33491744013, antoine.lefrere@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.