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Clinical Trials/NCT05497414
NCT05497414
Unknown
Not Applicable

Identifying Brain Dynamics Underlying Sleep and Mood in Depression

Boston University Charles River Campus1 site in 1 country60 target enrollmentJanuary 31, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depression
Sponsor
Boston University Charles River Campus
Enrollment
60
Locations
1
Primary Endpoint
Change in tasked evoked responses in amygdala ROI from baseline to post intervention
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2022
End Date
July 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in tasked evoked responses in amygdala ROI from baseline to post intervention

Time Frame: 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

Time Frame: Through study completion (approximately 1 month)

fMRI signal (units: %)

Change in fMRI signals in amygdala ROI from baseline to post intervention

Time Frame: Through study completion (approximately 1 month)

fMRI signal (units: %)

Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention

Time Frame: Through study completion (approximately 1 month)

Fluid flow measured with MRI (units: %)

Change in Montgomery-Asberg Depression Rating from baseline to post intervention

Time Frame: 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

Time Frame: Through study completion (approximately 1 month)

fMRI measure of hemodynamics (units: %)

Secondary Outcomes

  • 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))

Study Sites (1)

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