- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05497414
Neuroimaging Sleep and Mood in Depression
August 26, 2022 updated by: Boston University Charles River Campus
Identifying Brain Dynamics Underlying Sleep and Mood in Depression
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dabriel Zimmerman, BS
- Phone Number: 803-347-6699
- Email: dabrielz@bu.edu
Study Contact Backup
- Name: Stephanie Anakwe, BS
- Email: anakwes@bu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Boston University
-
Contact:
- Dabriel Zimmerman, BS
- Phone Number: 803-347-6699
- Email: dabrielz@bu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep deprived
Overnight sleep deprivation
|
Overnight sleep deprivation.
|
No Intervention: Rested
Well-rested sleep pattern
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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: %)
|
Through study completion (approximately 1 month)
|
Change in fMRI signals in amygdala ROI from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
fMRI signal (units: %)
|
Through study completion (approximately 1 month)
|
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: %)
|
Through study completion (approximately 1 month)
|
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: %)
|
Through study completion (approximately 1 month)
|
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
|
Through study completion (approximately 1 month)
|
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: %)
|
Through study completion (approximately 1 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in EEG dynamics from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
Amplitude of EEG signals (units: uV^2)
|
Through study completion (approximately 1 month)
|
Change in dot probe task performance from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
Behavior on emotional task (units: ms)
|
Through study completion (approximately 1 month)
|
Change in blood biomarkers of C-reactive protein from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
Blood analysis results (units: mg/L)
|
Through study completion (approximately 1 month)
|
Change in blood levels of Interleukin 6 from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
Measured in pg/mL
|
Through study completion (approximately 1 month)
|
Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
MRS measure of lactate (units: i.u.)
|
Through study completion (approximately 1 month)
|
Change in MRS measurement of myo-inositol from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
Magnetic Resonance Spectroscopy measure of myo-inositol (units: i.u.)
|
Through study completion (approximately 1 month)
|
Change in Positive and Negative Affect Scale 21 (PANAS-21) rating from baseline to post intervention
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.
|
Through study completion (approximately 1 month)
|
Change in Positive and Negative Affect Scale 21 (PANAS-21) rating during intervention
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.
|
Throughout intervention (approximately 17 hours)
|
Change in Shame Inventory rating from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
The Shame Inventory assess participants' feelings related to shame.
Units: scale.
|
Through study completion (approximately 1 month)
|
Change in Shame Inventory rating during intervention
Time Frame: Throughout intervention (approximately 17 hours)
|
The Shame Inventory assess participants' feelings related to shame.
Units: scale.
|
Throughout intervention (approximately 17 hours)
|
Change in Anxiety Sensitivity Index (ASI-3) rating from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
|
Through study completion (approximately 1 month)
|
Change in Anxiety Sensitivity Index (ASI-3) rating during intervention
Time Frame: Throughout intervention (approximately 17 hours)
|
The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.
|
Throughout intervention (approximately 17 hours)
|
Change in Depression, Anxiety, and Stress Scale (DASS-21) rating from baseline to post intervention
Time Frame: Through study completion (approximately 1 month)
|
The Depression, Anxiety, and Stress Scale assesses participants emotional states.
Units: scale.
|
Through study completion (approximately 1 month)
|
Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention
Time Frame: Throughout intervention (approximately 17 hours)
|
The Depression, Anxiety, and Stress Scale assesses participants emotional states.
Units: scale.
|
Throughout intervention (approximately 17 hours)
|
Patient health questionnaire (PHQ-9)
Time Frame: Pre-enrollment
|
This patient health questionnaire is used to compute a general depression score.Units: scale.
|
Pre-enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laura Lewis, PhD, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2022
Primary Completion (Anticipated)
July 1, 2024
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
August 9, 2022
First Posted (Actual)
August 11, 2022
Study Record Updates
Last Update Posted (Actual)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5562E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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