Boston University
Boston, Massachusetts, 02215, United States
NCT Number: NCT05497414
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for patient cohort only:
Exclusion criteria
Overnight sleep deprivation.
Time frame: Through study completion (approximately 1 month)
fMRI signal (units: %)
Time frame: Through study completion (approximately 1 month)
fMRI signal (units: %)
Time frame: Through study completion (approximately 1 month)
Task evoked responses in amygdala ROI (units: %)
Time frame: Through study completion (approximately 1 month)
Fluid flow measured with MRI (units: %)
Time frame: Through study completion (approximately 1 month)
Mood scores, measured on scale of 0-60
Time frame: Through study completion (approximately 1 month)
fMRI measure of hemodynamics (units: %)
Time frame: Through study completion (approximately 1 month)
Amplitude of EEG signals (units: uV^2)
Time frame: Through study completion (approximately 1 month)
Behavior on emotional task (units: ms)
Time frame: Through study completion (approximately 1 month)
Blood analysis results (units: mg/L)
Time frame: Through study completion (approximately 1 month)
Measured in pg/mL
Time frame: Through study completion (approximately 1 month)
MRS measure of lactate (units: i.u.)
Time frame: Through study completion (approximately 1 month)
Magnetic Resonance Spectroscopy measure of myo-inositol (units: i.u.)
Time frame: Through study completion (approximately 1 month)
The Positive and Negative Affect Scale (PANAS-21) assess positive and negative affect using scales relating to how participants feel about certain words.
Time frame: Throughout intervention (approximately 17 hours)
The Positive and Negative Affect Scale (PANAS-21) assess positive and negative affect using scales relating to how participants feel about certain words.
Time frame: Through study completion (approximately 1 month)
The Shame Inventory assess participants' feelings related to shame. Units: scale.
Time frame: Throughout intervention (approximately 17 hours)
The Shame Inventory assess participants' feelings related to shame. Units: scale.
Time frame: Through study completion (approximately 1 month)
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
Time frame: Throughout intervention (approximately 17 hours)
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
Time frame: Through study completion (approximately 1 month)
The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.
Time frame: Throughout intervention (approximately 17 hours)
The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.
Time frame: Pre-enrollment
This patient health questionnaire is used to compute a general depression score.Units: scale.
Boston University Charles River Campus
Other
Identifying Brain Dynamics Underlying Sleep and Mood in Depression
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05257902
Depressive Disorder, Depressive Disorder, Major
Seoul, Irwon-dong, Gangnam-gu, South Korea
View Trial DetailsNCT01962753
Depressive Disorder, Depressive Disorder, Major
Besançon, France
View Trial DetailsNCT06748274
Autonomous Dysfunction, Behavior
Bern, Canton of Bern, Switzerland
View Trial DetailsNCT01749124
Behavior, Behavioral Symptoms
Long Beach, California, United States
View Trial Details