Relationship Between Heart Rate Variability and Emotional Experience in Healthy and Depressed Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 6
- 主要终点
- Change in heart rate variability (HRV, also called RSA)
研究概览
简要总结
The purpose of this study is to understand if there is a relationship between the way that emotions are regulated by the brain and the way that heart rate is regulated by the brain. The study also seeks to understand whether having depression changes the way that emotions and heart rate are regulated.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-65 years
- •Able to understand and provide informed consent
- •Male and female
- •Depressed Subjects:
- •Current diagnosis of major depressive disorder (MDD) and currently in an major depressive episode (MDE)
- •Quick Inventory of Depressive Symptomology (QIDS-SR16) score of 11 or greater
- •Anticipated treatment with ketamine infusion for depression
排除标准
- •Current daily use of tricyclic antidepressants
- •Current diagnosis of cardiac arrhythmia or heart failure
- •Pregnancy
- •Current use of cardiac medications of the class beta-blockers
- •Current treatment with deep brain stimulation for any reason
- •Healthy Controls:
- •Current psychiatric treatment, including use of antidepressants or daily use of anxiolytic medication
- •Depressed Subjects:
- •Previous history of ketamine infusion for depression
- •Psychotic symptoms
- •Active co-morbid psychiatric diagnosis including anxiety disorder or personality disorder that significantly affects the current clinical condition, as determined by medical records
研究组 & 干预措施
Healthy Controls
Healthy controls will complete the video task and imaginal task in one session
干预措施: Video Task (Behavioral)
Healthy Controls
Healthy controls will complete the video task and imaginal task in one session
干预措施: Imaginal Task (Other)
Depressed + Ketamine
Subjects with major depressive disorder (MDD) who are scheduled to receive ketamine infusions will complete the video task and imaginal task twice. The first visit will be before any ketamine treatment. The second visit will be within 1 week after first ketamine infusion. This is NOT at treatment study. Study inclusion is open to participants with MDD who are already planning to receive ketamine treatment at Emory. No treatment is offered through this study.
干预措施: Video Task (Behavioral)
Depressed + Ketamine
Subjects with major depressive disorder (MDD) who are scheduled to receive ketamine infusions will complete the video task and imaginal task twice. The first visit will be before any ketamine treatment. The second visit will be within 1 week after first ketamine infusion. This is NOT at treatment study. Study inclusion is open to participants with MDD who are already planning to receive ketamine treatment at Emory. No treatment is offered through this study.
干预措施: Imaginal Task (Other)
结局指标
主要结局
Change in heart rate variability (HRV, also called RSA)
时间窗: Baseline, Post-Imaginal Task Session 2 (6 minutes)
RSA is measured by changes in the R-R interval (time between two of the distinctive, large, upward "R" spikes on an electrocardiogram (EKG)) synchronized with respiration. Change is the difference from between RSA at baseline and after imaginal task one week post-infusion.
次要结局
- Mean values of positive emotional expressions(Post-Imaginal Task Session 2 (6 minutes))
- Change in heart rate(Baseline, Post-Imaginal Task Session 2 (6 minutes))
- Mean values of negative emotional expressions(Post-Imaginal Task Session 2 (6 minutes))
- Change in skin conductance response (SCR)(Baseline, Post-Imaginal Task Session 2 (6 minutes))
- Change in pulse rate(Baseline, Post-Imaginal Task Session 2 (6 minutes))
- Mean activation of muscle action units(Post-Imaginal Task Session 2 (6 minutes))
- Change in respiration rate(Baseline, Post-Imaginal Task Session 2 (6 minutes))
研究者
Andrea Crowell
Senior Associate
Emory University