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

NCT ID: NCT05674019

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2025-01-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Neurodevelopmental Group

The volunteer presents at least 2 of 12 neurodevelopmental crieria

Group Type: EXPERIMENTAL

MRI exam

Intervention Type: OTHER

Brain MRI Morphometric exam

Non-neurodevelopmental Group

The volunteer does not present any of the 12 neurodevelopmental crieria

Group Type: ACTIVE_COMPARATOR

MRI exam

Intervention Type: OTHER

Brain MRI Morphometric exam

Interventions

MRI exam

Brain MRI Morphometric exam

Intervention Type: OTHER

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 :

1. The volunteer had at birth a paternal age ≥ 40 years

2. The volunteer had at birth a maternal age ≥ 35 years

3. The volunteer was born by cesarean section

4. The volunteer had a history of perinatal infection

5. The volunteer has a history of generalized anxiety disorder that began before the age of 16 (≤ 15 years)

6. The volunteer has a history of an eating disorder that began before the age of 16 (≤ 15 years)

7. The volunteer has a history of a substance use disorder (excluding tobacco) as described in the DSM-5 prior to age 16 (≤ 15 years)

8. The volunteer has a learning disability or "dys" disorder as defined in the DSM-5 or number of repeats > 2

9. The volunteer has a history of trauma assessed as severe by the CTQ self-assessment questionnaire

10. The volunteer has symptoms suggestive of Attention Deficit Hyperactivity Disorder (WURS score > 46)

11. The volunteer has a history of psychotic features during episodes.

12. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX

Role: STUDY_DIRECTOR

AP-HM

Central Contacts

Antoine LEFRERE

Role: CONTACT

antoine.lefrere@ap-hm.fr

+33491744013

Other Identifiers

RCAPHM21_0440

Identifier Type: -

Identifier Source: org_study_id