Bipolar DisorderNEMO-BipolarNCT05674019
MOrphometric MRI Analysis of Cortical Sulci: Development of NEurodevelopmental Biomarkers of Bipolar Disorder.
A study testing MRI exam in people with Bipolar Disorder, run by Assistance Publique Hopitaux De Marseille.
Trial summary
Given the phenotypic heterogeneity of bipolar disorder, it seems essential to propose new methodologies to improve the stratification of this pathology in order to describe more homogeneous groups of patients. In this perspective, the neurodevelopmental hypothesis of bipolar disorder seems promising. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- MRI exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- For the "neurodevelopmental" group :
- The volunteer has at least 2 of the 12 neurodevelopmental criteria
- For the "non-neurodevelopmental" group The volunteer does not present any of the 12 neurodevelopmental criteria
- List of the 12 neurodevelopmental criteria :
- The volunteer had at birth a paternal age ≥ 40 years
- The volunteer had at birth a maternal age ≥ 35 years
Show all 16Show fewer
- The volunteer was born by cesarean section
- The volunteer had a history of perinatal infection
- The volunteer has a history of generalized anxiety disorder that began before the age of 16 (≤ 15 years)
- The volunteer has a history of an eating disorder that began before the age of 16 (≤ 15 years)
- The volunteer has a history of a substance use disorder (excluding tobacco) as described in the DSM-5 prior to age 16 (≤ 15 years)
- The volunteer has a learning disability or "dys" disorder as defined in the DSM-5 or number of repeats > 2
- The volunteer has a history of trauma assessed as severe by the CTQ self-assessment questionnaire
- The volunteer has symptoms suggestive of Attention Deficit Hyperactivity Disorder (WURS score > 46)
- The volunteer has a history of psychotic features during episodes.
- The volunteer has an early age of onset of bipolar disorder at an age below 18 years.
Who cannot join
- Serious symptomatic or unstable physiological or medical condition (including pregnancy)
- History of stable or non-stable psychiatric illness, schizophrenia or any other condition that may interfere with bipolar disorder
- History of comorbid autism spectrum disorder
- History of severe head injury (GCS<8 at time of injury)
- Neurological disorder affecting central nervous system function
- Moderate to severe substance use disorder (>=4/11 as defined in the DSM-5) with the exception of tobacco use disorder
Show all 10Show fewer
- Under court protection or guardianship
- Unable to give the volunteer informed information, or the volunteer refuses to sign the consent form
- Insufficient command of the French language to complete the assessments
- Has a contraindication to MRI
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analyse Des Sillons Corticaux Par IRM morphométrique : développement de Biomarqueurs neurodéveloppementaux Des Troubles Bipolaires
Given the phenotypic heterogeneity of bipolar disorder, it seems essential to propose new methodologies to improve the stratification of this pathology in order to describe more homogeneous groups of patients. In this perspective, the neurodevelopmental hypothesis of bipolar disorder seems promising. Brain sulcation is an indirect marker of neurodevelopmental processes. The objective of the study is to highlight sulcal variations between a group of bipolar patients with a neurodevelopmental phenotype (ND) and a group of bipolar subjects without a ND phenotype. A sulcation marker (GPR56) will also be measured from patient blood samples. In order to carry out this project we would like to include 120 participants for a period of 12 months.
- Conditions
- Bipolar Disorder
- Being tested
- MRI exam
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examOther
Brain MRI Morphometric exam
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental Group | Experimental | The volunteer presents at least 2 of 12 neurodevelopmental crieria Receives: Other: MRI exam |
| Non-neurodevelopmental Group | Active comparator | The volunteer does not present any of the 12 neurodevelopmental crieria Receives: Other: MRI exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diifference in the occurrence of sulcal pits allowing to discriminate between a group of bipolar patients presenting a neurodevelopmental phenotype and a group of bipolar patients not presenting this phenotype.
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Measured: 24 months
Secondary outcomes (5)
The depth and number of sulcal pits to differentiate a group of bipolar patients with a neurodevelopmental phenotype from a group of bipolar patients without this phenotype.
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Measured: 24 months
The demonstration of correlations between different scores used in the clinic that may be related to neurodevelopmental manifestations of bipolar disorder (scales: WURS, minor neurological signs scale) and the number of sulcal-pits.
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Measured: 24 months
The blood level of GRP56 messenger RNA measured in whole blood by quantitative PCR to differentiate a group of bipolar patients with a neurodevelopmental phenotype and a group of bipolar patients without this phenotype
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Measured: 24 months
Genetic polymorphisms of GPR56 to differentiate between a group of bipolar patients with a neurodevelopmental phenotype and a group of bipolar patients without this phenotype
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Measured: 24 months
Protein quantification of the circulating fraction of GP56 in plasma and serum to differentiate a group of bipolar patients with a neurodevelopmental phenotype from a group of bipolar patients without this phenotype.
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion14 Jan 2025 (estimated)
- Study completion14 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Neurodevelopemental Group Non-neurodevelopmental Group
- Masking
- None (open label)
- Enrolment
- 120 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, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674019
- Sponsor's protocol ID
- RCAPHM21_0440
- Acronym
- NEMO-Bipolar
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse Des Sillons Corticaux Par IRM morphométrique : développement de Biomarqueurs neurodéveloppementaux Des Troubles Bipolaires
- ClinicalTrials.gov ID
- NCT05674019
- Acronym / sponsor ID
- NEMO-Bipolar / RCAPHM21_0440
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 14 Jan 2025 (estimated)
- Study completion
- 14 Jan 2025 (estimated)
- First posted
- 6 Jan 2023 (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.
Given the phenotypic heterogeneity of bipolar disorder, it seems essential to propose new methodologies to improve the stratification of this pathology in order to describe more homogeneous groups of patients. In this perspective, the neurodevelopmental hypothesis of bipolar disorder seems promising. Brain sulcation is an indirect marker of neurodevelopmental processes. The objective of the study is to highlight sulcal variations between a group of bipolar patients with a neurodevelopmental phenotype (ND) and a group of bipolar subjects without a ND phenotype. A sulcation marker (GPR56) will also be measured from patient blood samples. In order to carry out this project we would like to include 120 participants for a period of 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Neurodevelopemental Group Non-neurodevelopmental Group
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental Group | Experimental | Other: MRI examThe volunteer presents at least 2 of 12 neurodevelopmental crieria |
| Non-neurodevelopmental Group | Active comparator | Other: MRI examThe volunteer does not present any of the 12 neurodevelopmental crieria |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- The volunteer has at least 2 of the 12 neurodevelopmental criteria
- For the "non-neurodevelopmental" group The volunteer does not present any of the 12 neurodevelopmental criteria
- The volunteer had at birth a paternal age ≥ 40 years
- The volunteer had at birth a maternal age ≥ 35 years
- The volunteer was born by cesarean section
Key exclusion criteria (10 listed)
- Serious symptomatic or unstable physiological or medical condition (including pregnancy)
- History of stable or non-stable psychiatric illness, schizophrenia or any other condition that may interfere with bipolar disorder
- History of comorbid autism spectrum disorder
- History of severe head injury (GCS<8 at time of injury)
- Neurological disorder affecting central nervous system function
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 |
|---|---|---|
| MRI examBrain MRI Morphometric exam | Other | Neurodevelopmental Group, Non-neurodevelopmental Group |
Primary outcome
Diifference in the occurrence of sulcal pits allowing to discriminate between a group of bipolar patients presenting a neurodevelopmental phenotype and a group of bipolar patients not presenting this phenotype.
Time frame: 24 months
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
5 secondary outcomes
The depth and number of sulcal pits to differentiate a group of bipolar patients with a neurodevelopmental phenotype from a group of bipolar patients without this phenotype.
Time frame: 24 months
The demonstration of correlations between different scores used in the clinic that may be related to neurodevelopmental manifestations of bipolar disorder (scales: WURS, minor neurological signs scale) and the number of sulcal-pits.
Time frame: 24 months
The blood level of GRP56 messenger RNA measured in whole blood by quantitative PCR to differentiate a group of bipolar patients with a neurodevelopmental phenotype and a group of bipolar patients without this phenotype
Time frame: 24 months
Genetic polymorphisms of GPR56 to differentiate between a group of bipolar patients with a neurodevelopmental phenotype and a group of bipolar patients without this phenotype
Time frame: 24 months
Protein quantification of the circulating fraction of GP56 in plasma and serum to differentiate a group of bipolar patients with a neurodevelopmental phenotype from a group of bipolar patients without this phenotype.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
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
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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. This study is not recruiting at the moment.
François CREMIEUX study director
AP-HM
Questions about this trial
What is this clinical trial studying?
A study testing MRI exam in people with Bipolar Disorder, 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 16 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Jan 2023. 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. 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?
Results are not available in the source record.
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?
Diifference in the occurrence of sulcal pits allowing to discriminate between a group of bipolar patients presenting a neurodevelopmental phenotype and a group of bipolar patients not presenting this phenotype. (time frame: 24 months). 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 6 Jan 2023.