[11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Whole Brain Total Distribution Volume (VT)
研究概览
简要总结
Background:
Major depressive disorder (MDD) may have many underlying causes. One theory is that brain cells with low levels of a molecule called cyclic AMP (cAMP) may cause depression. A drug called ketamine may increase the levels of cAMP in a person's brain cells.
Objective:
To find out if administering ketamine to people with depression affects cAMP levels in their brains.
Eligibility:
People aged 18 to 70 with MDD who are enrolled in another NIH study that uses ketamine.
Design:
Participants will visit the NIH clinic 5 times in up to 6 weeks. Some of the visits may be spread out over more than 1 day.
Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a psychiatric evaluation. They will answer questions about their family history and mental health.
Participants will have a positron emission tomography (PET) scan. A small amount of a radioactive drug will be injected into a vein in their arm. Participants will lie on a bed that slides in and out of a doughnut-shaped machine that records images of their brains. They will have their heads in a holder to prevent movement. Each scan will last up to 2 hours.
After their first PET scan, participants will receive ketamine in a different study they are enrolled in. Then they will come back for another PET scan with the radioactive drug.
Participants will also have another scan called an MRI. They will lie on a table that slides into a metal tube. They will lie still for up to an hour....
详细描述
Study Description:
This study will test the effects of ketamine infusion on the cAMP system in human brain to determine if ketamine mediates its antidepressant effects at least in part due to modulation of cAMP signaling.
Objectives:
Primary Objective: To determine if ketamine infusions in depression causes increases in cAMP signaling as measured by [11C](R)-rolipram binding.
Secondary Objectives: To determine if increases in [11C](R)-rolipram correlate with symptomatic improvement in major depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects with major depression disorder (MDD)
Participants with major depressive disorder received 20 mCi of [11C](R)-rolipram intravenously for two PET scans, prior to and after ketamine infusion as well as brain MRI
干预措施: 11(R)-rolipram (Drug)
结局指标
主要结局
Whole Brain Total Distribution Volume (VT)
时间窗: 90 minutes after injection of 11C-R-Rolipram
Participants received 11C-R-Rolipram during PET scan and were scanned for 90 minutes with arterial blood sampling. Volume of distribution was calculated using two-tissue compartmental modeling. Participants had one PET scan pre-Ketamine and a second PET scan post-Ketamine administration.
次要结局
- Measure of Level of Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS)(Within two weeks of start of study (Pre) and within 7 days of Ketamine infusion (Post))
- Measure of Level of Depression Using the Hamilton Depression (HAM-D) Rating Scale(Within two weeks of start of study (Pre) and within 7 days of Ketamine infusion (Post))