Analyse Des Sillons Corticaux Par IRM morphométrique : développement de Biomarqueurs neurodéveloppementaux Des Troubles Bipolaires
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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.
时间窗: 24 months
Patients are identified in the neurodevelopmental group following a list of 12 criteria (0 criterion = non neurodevelopmental, at leat 2 criteria = neurodevelopmental)
次要结局
- 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)
- 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 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)
- 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)
- 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)