Neuroinflammation as a Novel Target to Treat Bipolar Depression: A Pilot PET Study With [11C]PBR-28 and N-Acetyl Cysteine (NAC) Antidepressant Treatment
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale
研究概览
简要总结
We are trying to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, we are looking at the importance of inflammation in the process. If you participate, you will have two different brain scans (MRI and PET scan). You will also have an experimental treatment for your depression named N-acetyl cysteine (NAC). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder. Please contact us if you are interested in participating. Up to $600 in compensation if you are eligible and choose to participate. Up to 6 months of treatment for depression at no cost to you.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Bipolar 2 disorder and meets criteria for a major depressive episode
- •Age 18-60
- •Females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study
- •Not currently taking psychotropic medications besides those allowed in the clinical trial
排除标准
- •Failed trial or intolerable side effects of NAC
- •Diagnosis of other major psychiatric disorders such as lifetime schizophrenia, schizoaffective disorder, psychotic features of bipolar disorder, current drug or alcohol abuse or recent drug or alcohol dependence
- •Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease. Any disorders with inflammation, malignancy, autoimmune or infectious etiology. Systolic blood pressure >140 or diastolic blood pressure > 100 Hemoglobin <11 in females or <13 in males
- •Metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body
- •Current, past or anticipated exposure to radiation
研究组 & 干预措施
Bipolar depressed
干预措施: N-acetyl cysteine (NAC) (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale
时间窗: Six weeks
Total score will be used; Ranges from 0 to 60 points; 60 is more most severe depression
次要结局
未报告次要终点
研究者
Martin Lan
Assistant Professor of Psychiatry
New York State Psychiatric Institute