Neuroimaging Sleep and Mood in Depression
Primary Purpose
Major Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
About this trial
This is an interventional basic science trial for Major Depression
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).
Sites / Locations
- Boston UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sleep deprived
Rested
Arm Description
Overnight sleep deprivation
Well-rested sleep pattern
Outcomes
Primary Outcome Measures
Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention
fMRI signal (units: %)
Change in fMRI signals in amygdala ROI from baseline to post intervention
fMRI signal (units: %)
Change in tasked evoked responses in amygdala ROI from baseline to post intervention
Task evoked responses in amygdala ROI (units: %)
Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention
Fluid flow measured with MRI (units: %)
Change in Montgomery-Asberg Depression Rating from baseline to post intervention
Mood scores, measured on scale of 0-60
Change in whole-brain voxelwise fMRI activity from baseline to post intervention
fMRI measure of hemodynamics (units: %)
Secondary Outcome Measures
Change in EEG dynamics from baseline to post intervention
Amplitude of EEG signals (units: uV^2)
Change in dot probe task performance from baseline to post intervention
Behavior on emotional task (units: ms)
Change in blood biomarkers of C-reactive protein from baseline to post intervention
Blood analysis results (units: mg/L)
Change in blood levels of Interleukin 6 from baseline to post intervention
Measured in pg/mL
Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention
MRS measure of lactate (units: i.u.)
Change in MRS measurement of myo-inositol from baseline to post intervention
Magnetic Resonance Spectroscopy measure of myo-inositol (units: i.u.)
Change in Positive and Negative Affect Scale 21 (PANAS-21) rating from baseline to post intervention
The Positive and Negative Affect Scale (PANAS-21) assess positive and negative affect using scales relating to how participants feel about certain words.
Change in Positive and Negative Affect Scale 21 (PANAS-21) rating during intervention
The Positive and Negative Affect Scale (PANAS-21) assess positive and negative affect using scales relating to how participants feel about certain words.
Change in Shame Inventory rating from baseline to post intervention
The Shame Inventory assess participants' feelings related to shame. Units: scale.
Change in Shame Inventory rating during intervention
The Shame Inventory assess participants' feelings related to shame. Units: scale.
Change in Anxiety Sensitivity Index (ASI-3) rating from baseline to post intervention
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
Change in Anxiety Sensitivity Index (ASI-3) rating during intervention
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
Change in Depression, Anxiety, and Stress Scale (DASS-21) rating from baseline to post intervention
The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.
Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention
The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.
Patient health questionnaire (PHQ-9)
This patient health questionnaire is used to compute a general depression score.Units: scale.
Full Information
NCT ID
NCT05497414
First Posted
February 24, 2022
Last Updated
August 26, 2022
Sponsor
Boston University Charles River Campus
Collaborators
One Mind, Brain & Behavior Research Foundation, 1907 Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05497414
Brief Title
Neuroimaging Sleep and Mood in Depression
Official Title
Identifying Brain Dynamics Underlying Sleep and Mood in Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
One Mind, Brain & Behavior Research Foundation, 1907 Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Two groups (healthy vs major depression) are studied under two conditions (rested vs sleep deprivation).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sleep deprived
Arm Type
Experimental
Arm Description
Overnight sleep deprivation
Arm Title
Rested
Arm Type
No Intervention
Arm Description
Well-rested sleep pattern
Intervention Type
Behavioral
Intervention Name(s)
Sleep deprivation
Intervention Description
Overnight sleep deprivation.
Primary Outcome Measure Information:
Title
Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention
Description
fMRI signal (units: %)
Time Frame
Through study completion (approximately 1 month)
Title
Change in fMRI signals in amygdala ROI from baseline to post intervention
Description
fMRI signal (units: %)
Time Frame
Through study completion (approximately 1 month)
Title
Change in tasked evoked responses in amygdala ROI from baseline to post intervention
Description
Task evoked responses in amygdala ROI (units: %)
Time Frame
Through study completion (approximately 1 month)
Title
Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention
Description
Fluid flow measured with MRI (units: %)
Time Frame
Through study completion (approximately 1 month)
Title
Change in Montgomery-Asberg Depression Rating from baseline to post intervention
Description
Mood scores, measured on scale of 0-60
Time Frame
Through study completion (approximately 1 month)
Title
Change in whole-brain voxelwise fMRI activity from baseline to post intervention
Description
fMRI measure of hemodynamics (units: %)
Time Frame
Through study completion (approximately 1 month)
Secondary Outcome Measure Information:
Title
Change in EEG dynamics from baseline to post intervention
Description
Amplitude of EEG signals (units: uV^2)
Time Frame
Through study completion (approximately 1 month)
Title
Change in dot probe task performance from baseline to post intervention
Description
Behavior on emotional task (units: ms)
Time Frame
Through study completion (approximately 1 month)
Title
Change in blood biomarkers of C-reactive protein from baseline to post intervention
Description
Blood analysis results (units: mg/L)
Time Frame
Through study completion (approximately 1 month)
Title
Change in blood levels of Interleukin 6 from baseline to post intervention
Description
Measured in pg/mL
Time Frame
Through study completion (approximately 1 month)
Title
Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention
Description
MRS measure of lactate (units: i.u.)
Time Frame
Through study completion (approximately 1 month)
Title
Change in MRS measurement of myo-inositol from baseline to post intervention
Description
Magnetic Resonance Spectroscopy measure of myo-inositol (units: i.u.)
Time Frame
Through study completion (approximately 1 month)
Title
Change in Positive and Negative Affect Scale 21 (PANAS-21) rating from baseline to post intervention
Description
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)
Title
Change in Positive and Negative Affect Scale 21 (PANAS-21) rating during intervention
Description
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)
Title
Change in Shame Inventory rating from baseline to post intervention
Description
The Shame Inventory assess participants' feelings related to shame. Units: scale.
Time Frame
Through study completion (approximately 1 month)
Title
Change in Shame Inventory rating during intervention
Description
The Shame Inventory assess participants' feelings related to shame. Units: scale.
Time Frame
Throughout intervention (approximately 17 hours)
Title
Change in Anxiety Sensitivity Index (ASI-3) rating from baseline to post intervention
Description
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
Time Frame
Through study completion (approximately 1 month)
Title
Change in Anxiety Sensitivity Index (ASI-3) rating during intervention
Description
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
Time Frame
Throughout intervention (approximately 17 hours)
Title
Change in Depression, Anxiety, and Stress Scale (DASS-21) rating from baseline to post intervention
Description
The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.
Time Frame
Through study completion (approximately 1 month)
Title
Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention
Description
The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.
Time Frame
Throughout intervention (approximately 17 hours)
Title
Patient health questionnaire (PHQ-9)
Description
This patient health questionnaire is used to compute a general depression score.Units: scale.
Time Frame
Pre-enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dabriel Zimmerman, BS
Phone
803-347-6699
Email
dabrielz@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Anakwe, BS
Email
anakwes@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Lewis, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dabriel Zimmerman, BS
Phone
803-347-6699
Email
dabrielz@bu.edu
12. IPD Sharing Statement
Learn more about this trial
Neuroimaging Sleep and Mood in Depression
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