MOrphometric MRI Analysis of Cortical Sulci: Development of NEurodevelopmental Biomarkers of Bipolar Disorder.

NCT05674019 | Unknown

• 1 other identifier: RCAPHM21_0440
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  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.

  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

  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

  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.

  24 months

Study Arms (2)

Neurodevelopmental Group

EXPERIMENTAL

The volunteer presents at least 2 of 12 neurodevelopmental crieria

Other: MRI exam

Non-neurodevelopmental Group

ACTIVE COMPARATOR

The volunteer does not present any of the 12 neurodevelopmental crieria

Other: MRI exam

Interventions

MRI exam OTHER

Brain MRI Morphometric exam

Neurodevelopmental Group; Non-neurodevelopmental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• François CREMIEUX

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Antoine LEFRERE

CONTACT

+33491744013; antoine.lefrere@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Neurodevelopemental Group Non-neurodevelopmental Group

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: January 15, 2023
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share