Investigation of Lithium on Signal Transduction, Gene Expression and Brain Myo-Inositol Levels in Manic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Brain myo-inositol levels
研究概览
简要总结
This study investigates the effects of Lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with Bipolar disorder. It is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.
详细描述
This study investigates the effects of blinded lithium treatment longitudinally in patients with bipolar disorder. At baseline and at multiple time points following the initiation of lithium treatment over 4 or more weeks, measures of signal transduction pathways, gene expression and brain neurochemistry and structure were obtained. It is hypothesized that modulation of these measures will be predictive of lithium treatment responsiveness.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet diagnostic criteria for Bipolar Mood Disorder determined by DSM-IV (SCID)
排除标准
- •Meeting criteria for any other DSM-IV axis I disorder
- •Psychoactive substance abuse or dependence within the past 1 year
- •Medical conditions placing patients at increased risk for lithium treatment (including renal disease, hepatic disease, hematological disease)
- •Devices/implants or conditions which preclude MRI investigation (including cardiac pacemaker/ICD, aneurysm clips, neurostimulator device, metallic fragments in or near the eye,claustrophobia)
研究组 & 干预措施
Blinded Lithium
Bipolar Disorder patients
干预措施: Lithium Carbonate (Drug)
结局指标
主要结局
Brain myo-inositol levels
时间窗: 4 weeks
次要结局
- Signal transduction pathway measures(4 weeks)
- Gene expression levels(4 weeks)
- Brain volume(4 weeks)