Broadband Near Infrared Spectroscopy to Elucidate the of Role Cortical Brain Cytochrome C Oxidase Activity in the Pathophysiology of Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bipolar Depression Rating Scale
研究概览
简要总结
People with a diagnosis of bipolar disorder who are depressed will have a light-based imaging of the brain (Near Infrared Spectroscopy) before and after they have treatment for their depression with a standard, approved medication named lurasidone. They will also answer questions about their history, and give blood samples. The goal is to understand the role of mitochondrial activity in bipolar disorder. Healthy volunteers who have never had a psychiatric disorder will have the same procedures, but they will not receive the medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Diagnosis of bipolar disorder
- •Having symptoms of depression
- •Taking less than three medications for bipolar disorder
排除标准
- •Taking any medications that cannot be combined with lurasidone
- •Any medical problems that are not well treated
- •Any drug or alcohol use disorders that are moderate or severe
- •Any severe suicidal ideation, or having had a suicide attempt in the last five years
- •Any psychotic symptoms that have occurred outside of a mood episode
- •Any electroconvulsive therapy (ECT) within the last six months
- •Currently pregnant or planning to become pregnant during the time of the study
研究组 & 干预措施
Healthy Volunteer
Healthy Volunteers will have all research procedures, but will not receive medication treatment
Bipolar Disorder
Participants in a major depressive episode will receive standard treatment with lurasidone for six weeks. Doses can be adjusted based on clinical need.
干预措施: Lurasidone (Latuda) (Drug)
结局指标
主要结局
Bipolar Depression Rating Scale
时间窗: 6 weeks
A measure of depression severity. Higher numbers indicate more symptoms.
次要结局
未报告次要终点
研究者
Martin Lan
Research Scientist VI
New York State Psychiatric Institute