Back to resultsMOrphometric MRI Analysis of Cortical Sulci: Development of NEurodevelopmental Biomarkers of Bipolar Disorder. (NEMO-Bipolar)
Primary Purpose
Bipolar Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI exam
Sponsored by
About this trial
This is an interventional other trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neurodevelopmental Group
Non-neurodevelopmental Group
Arm Description
The volunteer presents at least 2 of 12 neurodevelopmental crieria
The volunteer does not present any of the 12 neurodevelopmental crieria
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
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)
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)
Full Information
NCT ID
NCT05674019
First Posted
December 21, 2022
Last Updated
December 21, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT05674019
Brief Title
MOrphometric MRI Analysis of Cortical Sulci: Development of NEurodevelopmental Biomarkers of Bipolar Disorder.
Acronym
NEMO-Bipolar
Official Title
Analyse Des Sillons Corticaux Par IRM morphométrique : développement de Biomarqueurs neurodéveloppementaux Des Troubles Bipolaires
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
January 14, 2025 (Anticipated)
Study Completion Date
January 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Neurodevelopemental Group Non-neurodevelopmental Group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurodevelopmental Group
Arm Type
Experimental
Arm Description
The volunteer presents at least 2 of 12 neurodevelopmental crieria
Arm Title
Non-neurodevelopmental Group
Arm Type
Active Comparator
Arm Description
The volunteer does not present any of the 12 neurodevelopmental crieria
Intervention Type
Other
Intervention Name(s)
MRI exam
Intervention Description
Brain MRI Morphometric exam
Primary Outcome Measure Information:
Title
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.
Description
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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.
Description
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Time Frame
24 months
Title
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.
Description
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Time Frame
24 months
Title
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
Description
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Time Frame
24 months
Title
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
Description
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Time Frame
24 months
Title
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.
Description
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine LEFRERE
Phone
+33491744013
Email
antoine.lefrere@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
AP-HM
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MOrphometric MRI Analysis of Cortical Sulci: Development of NEurodevelopmental Biomarkers of Bipolar Disorder.
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