A Multimodal Brain Imaging Study to Investigate Neural Correlates for Therapeutic Mechanisms of Lithium in Bipolar Disorder: Glycogen Synthase Kinase 3β Single Nucleotide Polymorphisms and Gray Matter Volume Increase Following Lithium Treatment in Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from baseline in manic symptom scores at 12 weeks
研究概览
简要总结
The investigators will assess Li-induced gray matter volume changes with regard to the endophenotype of GSK3beta polymorphism. The changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of Li, which were closely related to the inhibition of apoptotic activity of GSK3beta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women aged between 19 and 55
- •Diagnosis of bipolar I disorder as assessed by the structured clinical interview for DSM-IV (SCID-IV)
- •Patients who have not used psychoactive medications for more than 2 weeks
- •Individuals who provided written consent for participation
排除标准
- •Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
- •Women who are pregnant, breastfeeding, or planning pregnancy
- •Diagnosis of any Axis I disorder other than bipolar disorder
- •Intelligence quotient below 80
- •Current or past drug abuse
- •Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
研究组 & 干预措施
Lithium
干预措施: Lithium (Drug)
结局指标
主要结局
Change from baseline in manic symptom scores at 12 weeks
时间窗: Baseline and at 12 weeks
Change from baseline in manic symptom scores at 8 weeks
时间窗: Baseline and at 8 weeks
Change from baseline in manic symptom scores at 4 weeks
时间窗: Baseline and at 4 weeks
Change from baseline in manic symptom scores at 1 week
时间窗: Baseline and at 1 week
Change from baseline in depressive symptom scores at 12 weeks
时间窗: Baseline and at 12 weeks
Change from baseline in depressive symptom scores at 8 weeks
时间窗: Baseline and at 8 weeks
Change from baseline in depressive symptom scores at 4 weeks
时间窗: Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 1 week
时间窗: Baseline and at 1 week
Change from baseline in global function scores at 12 weeks
时间窗: Baseline and at 12 weeks
Change from baseline in global function scores at 8 weeks
时间窗: Baseline and at 8 weeks
Change from baseline in global function scores at 4 weeks
时间窗: Baseline and at 4 weeks
Change from baseline in global function scores at 1 week
时间窗: Baseline and at 1 week
次要结局
- Changes from baseline in brain structure analyzed using computational approach(Baseline and at 12 weeks)
- Number of participants with adverse events(1 week)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University