Brain Ion Homeostasis, Lithium and Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Study the relationship between BLC and brain sodium ion homeostasis, as measured by concurrent Single / Triple quantum sodium MRI in BPD patients
研究概览
简要总结
In this project, investigators intend to carry out the first simultaneous, in vivo, imaging study of lithium content and sodium ion homeostasis in the brain of Bipolar Disorder (BPD) patients under Lithium therapy.
详细描述
The purpose of this study is to validate a new method for the measurement of the amount of lithium (also known as lithium concentration) in the brain of subjects undergoing lithium treatment for bipolar disorder. The method involves the use of Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) techniques. These are non-invasive techniques, with no known harmful effects, that allow investigators to measure the amount of lithium in an individual's brain. There will be no contrast dye used in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Psychiatrically stable patients (diagnosed according to the Diagnostic and Statistical Manual, DSM-IV, criteria)
- •On steady state serum lithium levels (0.8-1.2mEq/L)
排除标准
- •Subjects who have a history of head trauma
- •Subjects who have a contraindication for an MRI exam, including a claustrophobia, surgical or vascular implants, pregnancy, pacemakers, neurostimulators, history of metal in the eyes, and orthodontia or extensive bridgework (with have a particular impact on gradient echo imaging).
结局指标
主要结局
Study the relationship between BLC and brain sodium ion homeostasis, as measured by concurrent Single / Triple quantum sodium MRI in BPD patients
时间窗: 1 Hour
次要结局
- To investigate the measurement of sodium ion homeostasis in the brain of BPD patients, at clinical magnetic field strengths (3 Tesla), as a non-invasive surrogate marker of BLC during Lithium Carbonate therapy(1 Hour)