NCT04251234终止不适用
Light at Night Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Melatonin levels
研究概览
简要总结
The purpose of this mechanistic study is to examine light sensitivity (melatonin suppression) in people with bipolar depression I, and compare it to healthy controls. This is not a treatment study.
详细描述
The bipolar disorder I and healthy control arms are recruited from the existing Heinz C. Prechter Bipolar Research Program at the University of Michigan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
There is no masking. The dim light (<1 lux) condition is first, followed by the room light (~30 lux) condition. Participants are aware of this condition order.
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
- •BMI 18-30 kg/m2
- •Appropriate sleep schedules according to study staff. Sleep schedule is self-reported and confirmed through a sleep diary
- •Healthy eyes as ascertained by eye exam at University of Michigan Kellogg Eye Center
- •Willing and able to maintain stable sleep schedule during study.
- •Participants will be breathalyzed and undergo urine drugs screens at every lab visit
- •Acknowledge and understand that participants cannot drive themselves home after certain lab visits. Note that the research team will provide a travel stipend of $10 per visit to offset potential rideshare/taxi costs
排除标准
- •Color blindness
结局指标
主要结局
Melatonin levels
时间窗: Up to approximately 6 weeks
Melatonin will be reported as an average percentage of suppression in the \~30 lux condition as compared to \<1 lux
次要结局
未报告次要终点
研究者
Helen Burgess
Professor of Psychiatry
University of Michigan
研究点 (2)
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