Identifying Brain Dynamics Underlying Sleep and Mood in Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in tasked evoked responses in amygdala ROI from baseline to post intervention
研究概览
简要总结
This study will investigate how sleep and mood are related in patients with depression and in healthy controls. It will use MRI-based measures of brain function to determine how neural systems are modulated by sleep and sleep deprivation, and its links to mood in depression.
详细描述
The purpose of this work is to identify brain networks that underlie sleep and mood using a combination of EEG and fMRI. Sleep deprivation can elicit rapid improvements in mood in some patients with depression, while some patients do not show any significant changes in mood. We will image the brain while measuring physiological and electrical signals in healthy individuals and in patients with depression. Subjects will participate in combined EEG-MRI studies that will involve the use of perceptual and attentional tasks, and will involve recording physiological variables such as breathing, heart rate, eye movements, and blood pressure. If combined EEG-MRI cannot be completed due to data quality reasons, subjects will participate in EEG or MRI alone. Subjects will participate in a blood draw to assess for inflammatory markers related to mood. Subjects will be either well-rested or sleep deprived. For sleep deprivation, subjects will be asked to stay awake overnight under the supervision of a member of the study team at Boston University, and then would be asked to do an fMRI, EEG, or EEG-MRI scan. fMRI studies will be performed at the Boston University Center for Cognitive Neuroimaging. During the study visit, subjects will answer questions in structured interviews, will fill out questionnaires that will contain questions related to their mental health. Subjects will be shown visual stimuli and/or listen to auditory stimuli, and/or asked to perform simple behavioral tasks related to these stimuli. Some of the visual stimuli will be emotionally salient. Wrist actigraphy will be used to monitor sleep behavior. Remote daily mood and sleep assessments will be performed for up to two weeks prior to imaging. These assessments will be sent as emails or text messages to participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult aged 18-80
- •Inclusion criteria for patient cohort only:
- •- Current diagnosis of major depressive disorder
排除标准
- •Must not have ferrous metal implanted in head or body
- •Must have no history of major head trauma
- •Must not have implanted electronic devices (e.g., pacemaker, neurostimulator)
- •Must not be pregnant, suspect they are pregnant, or seeking to become pregnant
- •Must not be claustrophobic
- •Must have no piercings or jewelry that cannot be removed
- •Weight less than 250 pounds
- •No lifetime history of schizophrenia or any other psychosis disorder, substantial intellectual disability, bipolar disorder, post-traumatic stress disorder or obsessive compulsive disorder
- •No alcohol or substance abuse or dependence within the past 6 months
- •No significant personality dysfunction
- •Must not indicate significant suicide risk.
- •Must not be taking medications that significantly affect sleep, psychiatric function, blood/vascular function, or anti-inflammatory medications (other than minor NSAID use).
研究组 & 干预措施
Sleep deprived
Overnight sleep deprivation
干预措施: Sleep deprivation (Behavioral)
Rested
Well-rested sleep pattern
结局指标
主要结局
Change in tasked evoked responses in amygdala ROI from baseline to post intervention
时间窗: Through study completion (approximately 1 month)
Task evoked responses in amygdala ROI (units: %)
Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention
时间窗: Through study completion (approximately 1 month)
fMRI signal (units: %)
Change in fMRI signals in amygdala ROI from baseline to post intervention
时间窗: Through study completion (approximately 1 month)
fMRI signal (units: %)
Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention
时间窗: Through study completion (approximately 1 month)
Fluid flow measured with MRI (units: %)
Change in Montgomery-Asberg Depression Rating from baseline to post intervention
时间窗: Through study completion (approximately 1 month)
Mood scores, measured on scale of 0-60
Change in whole-brain voxelwise fMRI activity from baseline to post intervention
时间窗: Through study completion (approximately 1 month)
fMRI measure of hemodynamics (units: %)
次要结局
- Change in Positive and Negative Affect Scale 21 (PANAS-21) rating during intervention(Throughout intervention (approximately 17 hours))
- Change in Anxiety Sensitivity Index (ASI-3) rating from baseline to post intervention(Through study completion (approximately 1 month))
- Change in Anxiety Sensitivity Index (ASI-3) rating during intervention(Throughout intervention (approximately 17 hours))
- Change in Depression, Anxiety, and Stress Scale (DASS-21) rating from baseline to post intervention(Through study completion (approximately 1 month))
- Change in dot probe task performance from baseline to post intervention(Through study completion (approximately 1 month))
- Change in blood biomarkers of C-reactive protein from baseline to post intervention(Through study completion (approximately 1 month))
- Change in blood levels of Interleukin 6 from baseline to post intervention(Through study completion (approximately 1 month))
- Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention(Through study completion (approximately 1 month))
- Change in EEG dynamics from baseline to post intervention(Through study completion (approximately 1 month))
- Change in Shame Inventory rating during intervention(Throughout intervention (approximately 17 hours))
- Patient health questionnaire (PHQ-9)(Pre-enrollment)
- Change in MRS measurement of myo-inositol from baseline to post intervention(Through study completion (approximately 1 month))
- Change in Positive and Negative Affect Scale 21 (PANAS-21) rating from baseline to post intervention(Through study completion (approximately 1 month))
- Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention(Throughout intervention (approximately 17 hours))
- Change in Shame Inventory rating from baseline to post intervention(Through study completion (approximately 1 month))