18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale
研究概览
简要总结
The goal of this project is to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, the project focuses on the importance of dopamine signaling in the process. Participants will have two different brain scans (MRI and PET scan). They will also have treatment for your depression with an FDA approved medication, lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bipolar I disorder, bipolar II disorder or other specified bipolar disorder
- •Currently in a major depressive episode and moderately depressed
- •Age 18-50 years old
- •Patients on psychiatric medications will not be benefitting from those medications
- •Females of childbearing potential must be willing to use an acceptable form of birth control throughout the study
排除标准
- •Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance use disorder, recent anorexia or bulimia nervosa
- •Previous failed trial of lurasidone, or had intolerable side effects of lurasidone
- •Significant active physical illness
- •Actively suicidal
- •ECT within the past 6 months
- •Recent pregnancy, abortion or miscarriage or plans to conceive during the study; currently lactating
- •Metal in the body that is not MRI compatible
- •Current, past or anticipated exposure to radiation
- •Currently taking an anticoagulant medication
研究组 & 干预措施
Lurasidone
Open-label treatment with lurasidone within the dose range of 20-60 mg daily
干预措施: Lurasidone (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale
时间窗: 15 minutes
Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome.
次要结局
未报告次要终点
研究者
Martin Lan
Assistant Professor of Psychiatry at CUMC
New York State Psychiatric Institute