Neuroimaging Sleep and Mood in Depression

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05497414
Collaborator
One Mind (Other), Brain & Behavior Research Foundation (Other), 1907 Foundation (Other)
60
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2
29
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sleep deprivation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Two groups (healthy vs major depression) are studied under two conditions (rested vs sleep deprivation).Two groups (healthy vs major depression) are studied under two conditions (rested vs sleep deprivation).
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Identifying Brain Dynamics Underlying Sleep and Mood in Depression
Actual Study Start Date :
Jan 31, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sleep deprived

Overnight sleep deprivation

Behavioral: Sleep deprivation
Overnight sleep deprivation.

No Intervention: Rested

Well-rested sleep pattern

Outcome Measures

Primary Outcome Measures

  1. Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention [Through study completion (approximately 1 month)]

    fMRI signal (units: %)

  2. Change in fMRI signals in amygdala ROI from baseline to post intervention [Through study completion (approximately 1 month)]

    fMRI signal (units: %)

  3. Change in tasked evoked responses in amygdala ROI from baseline to post intervention [Through study completion (approximately 1 month)]

    Task evoked responses in amygdala ROI (units: %)

  4. Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention [Through study completion (approximately 1 month)]

    Fluid flow measured with MRI (units: %)

  5. Change in Montgomery-Asberg Depression Rating from baseline to post intervention [Through study completion (approximately 1 month)]

    Mood scores, measured on scale of 0-60

  6. Change in whole-brain voxelwise fMRI activity from baseline to post intervention [Through study completion (approximately 1 month)]

    fMRI measure of hemodynamics (units: %)

Secondary Outcome Measures

  1. Change in EEG dynamics from baseline to post intervention [Through study completion (approximately 1 month)]

    Amplitude of EEG signals (units: uV^2)

  2. Change in dot probe task performance from baseline to post intervention [Through study completion (approximately 1 month)]

    Behavior on emotional task (units: ms)

  3. Change in blood biomarkers of C-reactive protein from baseline to post intervention [Through study completion (approximately 1 month)]

    Blood analysis results (units: mg/L)

  4. Change in blood levels of Interleukin 6 from baseline to post intervention [Through study completion (approximately 1 month)]

    Measured in pg/mL

  5. Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention [Through study completion (approximately 1 month)]

    MRS measure of lactate (units: i.u.)

  6. Change in MRS measurement of myo-inositol from baseline to post intervention [Through study completion (approximately 1 month)]

    Magnetic Resonance Spectroscopy measure of myo-inositol (units: i.u.)

  7. Change in Positive and Negative Affect Scale 21 (PANAS-21) rating from baseline to post intervention [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.

  8. Change in Positive and Negative Affect Scale 21 (PANAS-21) rating during intervention [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.

  9. Change in Shame Inventory rating from baseline to post intervention [Through study completion (approximately 1 month)]

    The Shame Inventory assess participants' feelings related to shame. Units: scale.

  10. Change in Shame Inventory rating during intervention [Throughout intervention (approximately 17 hours)]

    The Shame Inventory assess participants' feelings related to shame. Units: scale.

  11. Change in Anxiety Sensitivity Index (ASI-3) rating from baseline to post intervention [Through study completion (approximately 1 month)]

    The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.

  12. Change in Anxiety Sensitivity Index (ASI-3) rating during intervention [Throughout intervention (approximately 17 hours)]

    The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.

  13. Change in Depression, Anxiety, and Stress Scale (DASS-21) rating from baseline to post intervention [Through study completion (approximately 1 month)]

    The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.

  14. Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention [Throughout intervention (approximately 17 hours)]

    The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.

  15. Patient health questionnaire (PHQ-9) [Pre-enrollment]

    This patient health questionnaire is used to compute a general depression score.Units: scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston University Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Boston University Charles River Campus
  • One Mind
  • Brain & Behavior Research Foundation
  • 1907 Foundation

Investigators

  • Principal Investigator: Laura Lewis, PhD, Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT05497414
Other Study ID Numbers:
  • 5562E
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022