NCT06968598尚未招募不适用
Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder with a neurodevelopmental (ND) component, compared with patients with bipolar disorder without ND component.
研究概览
简要总结
Demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder (BD) with a neurodevelopmental (ND) component, compared with patients with bipolar disorder (BD) without an ND component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Presence of bipolar disorder according to DSM-5 criteria
- •Able to freely give and sign consent
- •Affiliated or beneficiary of a health insurance plan
- •Previous participants in the NEMO study (2022-A00353-40)
- •For the "neurodevelopmental bipolar" (ND-BP) group: presence of a neurodevelopmental burden score in the top 5, as assessed in the NEMO project (NCT05674019).
- •For the "non-neurodevelopmental bipolar" group (TB): presence of a neurodevelopmental load score of 0, or in the lowest 5, as assessed in the NEMO project.
排除标准
- •- Presence of a severe symptomatic or unstable physiological or medical condition (including pregnancy)
- •History of psychiatric illness (stable or not), schizophrenia or any other pathology likely to interfere with bipolar disorder
- •History of severe head trauma (GCS<8 at time of trauma)
- •Presence of a neurological disorder affecting central nervous system function
- •Presence of moderate to severe substance use disorders (>=4/11 as defined in DSM-5), with the exception of tobacco use disorders.
- •The volunteer is under court protection or guardianship
- •It proves impossible to give the volunteer informed information, or the volunteer refuses to sign the consent form.
- •Insufficient command of the French language to complete evaluations
研究组 & 干预措施
Neurodevelopmental alteration
Experimental
blood sampling to generate organoids in the ND group
干预措施: blood sample (Other)
No Neurodevelopmental alteration
Placebo Comparator
blood sampling to generate organoids in the non- ND group
干预措施: blood sample (Other)
结局指标
主要结局
Demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder with a neurodevelopmental (ND) component, compared with patients with bipolar disorder without ND component.
时间窗: Through study completion, an average of 2 year
Organization of cortical layers in both subgroups
次要结局
- Establish induced pluripotent stem cell (iPSC) lines from cryopreserved PBMCs of the TB-ND subgroup(Through study completion, an average of 2 year)
- Quality of cortical organoids produced from these iPSCs(Through study completion, an average of 2 year)
- Assessing the reproducibility of the iPSC derivation protocol in cortical organoids(Through study completion, an average of 2 year)
研究者
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