Clinical trial NCT05497414: Neuroimaging Sleep and Mood in Depression
Official title: Identifying Brain Dynamics Underlying Sleep and Mood in Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depression
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: One Mind
name: Brain & Behavior Research Foundation
name: 1907 Foundation
First posted: 2022-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Two groups (healthy vs major depression) are studied under two conditions (rested vs sleep deprivation).
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion criteria:

* Adult aged 18-80

Inclusion criteria for patient cohort only:

- Current diagnosis of major depressive disorder

Exclusion criteria:

* 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).

Primary outcomes:
measure: Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in fMRI signals in amygdala ROI from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in tasked evoked responses in amygdala ROI from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in Montgomery-Asberg Depression Rating from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in whole-brain voxelwise fMRI activity from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
Secondary outcomes:
measure: Change in EEG dynamics from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in dot probe task performance from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in blood biomarkers of C-reactive protein from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in blood levels of Interleukin 6 from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in MRS measurement of myo-inositol from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in Positive and Negative Affect Scale 21 (PANAS-21) rating from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in Positive and Negative Affect Scale 21 (PANAS-21) rating during intervention
timeFrame: Throughout intervention (approximately 17 hours)
measure: Change in Shame Inventory rating from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in Shame Inventory rating during intervention
timeFrame: Throughout intervention (approximately 17 hours)
measure: Change in Anxiety Sensitivity Index (ASI-3) rating from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in Anxiety Sensitivity Index (ASI-3) rating during intervention
timeFrame: Throughout intervention (approximately 17 hours)
measure: Change in Depression, Anxiety, and Stress Scale (DASS-21) rating from baseline to post intervention
timeFrame: Through study completion (approximately 1 month)
measure: Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention
timeFrame: Throughout intervention (approximately 17 hours)
measure: Patient health questionnaire (PHQ-9)
timeFrame: Pre-enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Laura Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References: