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Not Yet Recruiting NCT05674019

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

Conditions: Bipolar Disorder

Sex: All
Ages: 18 Years – 60 Years
Phase: NA
Enrollment: 120
Sponsor: Assistance Publique Hopitaux De Marseille

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.

Eligibility Criteria

Inclusion Criteria:For the "neurodevelopmental" group :The volunteer has at least 2 of the 12 neurodevelopmental criteriaFor the "non-neurodevelopmental" group The volunteer does not present any of the 12 neurodevelopmental criteriaList of the 12 neurodevelopmental criteria :The volunteer had at birth a paternal age ≥ 40 yearsThe volunteer had at birth a maternal age ≥ 35 yearsThe volunteer was born by cesarean sectionThe volunteer had a history of perinatal infectionThe 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 > 2The volunteer has a history of trauma assessed as severe by the CTQ self-assessment questionnaireThe 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 disorderHistory of comorbid autism spectrum disorderHistory of severe head injury (GCS<8 at time of injury)Neurological disorder affecting central nervous system functionModerate to severe substance use disorder (>=4/11 as defined in the DSM-5) with the exception of tobacco use disorderUnder court protection or guardianshipUnable to give the volunteer informed information, or the volunteer refuses to sign the consent formInsufficient command of the French language to complete the assessmentsHas a contraindication to MRI

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Source: ClinicalTrials.gov (NCT05674019). StuddyBuddy aggregates publicly available trial information.