The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.
研究概览
简要总结
There is good evidence to suggest that the pathological version of sadness that people with Major Depression experience could be caused by the failure of the hormone cortisol to properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This project investigates if the subgenual cingulate cortex has become insensitive to cortisol in patients with depression and tests for variants of the cortisol receptor genes that could predispose individuals to develop cortisol insensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Participants must have no Axis 1 mental disorder
- •Participants with depression must meet minimum severity levels (Hamilton >7)
- •All participants must weight less than 280 pounds for the purposes of MRI scanning
排除标准
- •In order to protect against risk associated with taking Hydrocortisone, all participants must not have any of the following:
- •Psychotropic medications
- •Recent surgery
- •Endocrine disorders
- •Liver disease
- •Kidney disease
- •Thyroid disorder
- •History of malaria
- •Tuberculosis
- •Osteoporosis
- •Glaucoma/cataracts
- •Chronic expressed infections (herpes --including ocular herpes, HIV, etc.)
- •History of congestive heart failure
- •History of recurring seizures
- •Stomach Ulcers
- •Comorbid psychosis
- •Current use of illicit drugs
- •High Blood pressure
- •In order to protect against risks associated with MRI scanning participants must not be/have any of the following:
- •>280 lbs
- •In-dwelling ferrous metals
- •Left Handed
- •Abnormal Hearing
- •Claustrophobic
- •Head injury with loss of consciousness
研究组 & 干预措施
Healthy
Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
干预措施: Hydrocortisone acetate (Drug)
Healthy
Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
干预措施: Placebo (Drug)
Depression
Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
干预措施: Hydrocortisone acetate (Drug)
Depression
Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
干预措施: Placebo (Drug)
结局指标
主要结局
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.
时间窗: 2 hours
次要结局
未报告次要终点
研究者
Keith Sudheimer
Clinical Assistant Professor
Stanford University