Neuroimaging Sleep and Mood in Depression

Major Depression Clinical Trial

Official title:

Identifying Brain Dynamics Underlying Sleep and Mood in Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497414
• Other study ID #: 5562E
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2022
• Source: Boston University Charles River Campus
• Contact: Dabriel Zimmerman, BS
• Phone: 803-347-6699
• Email: dabrielz[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression

Intervention

Behavioral:
• Sleep deprivation
Overnight sleep deprivation.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University Charles River Campus	1907 Foundation, Brain & Behavior Research Foundation, One Mind

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention	fMRI signal (units: %)	Through study completion (approximately 1 month)
Primary	Change in fMRI signals in amygdala ROI from baseline to post intervention	fMRI signal (units: %)	Through study completion (approximately 1 month)
Primary	Change in tasked evoked responses in amygdala ROI from baseline to post intervention	Task evoked responses in amygdala ROI (units: %)	Through study completion (approximately 1 month)
Primary	Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention	Fluid flow measured with MRI (units: %)	Through study completion (approximately 1 month)
Primary	Change in Montgomery-Asberg Depression Rating from baseline to post intervention	Mood scores, measured on scale of 0-60	Through study completion (approximately 1 month)
Primary	Change in whole-brain voxelwise fMRI activity from baseline to post intervention	fMRI measure of hemodynamics (units: %)	Through study completion (approximately 1 month)
Secondary	Change in EEG dynamics from baseline to post intervention	Amplitude of EEG signals (units: uV^2)	Through study completion (approximately 1 month)
Secondary	Change in dot probe task performance from baseline to post intervention	Behavior on emotional task (units: ms)	Through study completion (approximately 1 month)
Secondary	Change in blood biomarkers of C-reactive protein from baseline to post intervention	Blood analysis results (units: mg/L)	Through study completion (approximately 1 month)
Secondary	Change in blood levels of Interleukin 6 from baseline to post intervention	Measured in pg/mL	Through study completion (approximately 1 month)
Secondary	Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention	MRS measure of lactate (units: i.u.)	Through study completion (approximately 1 month)
Secondary	Change in MRS measurement of myo-inositol from baseline to post intervention	Magnetic Resonance Spectroscopy measure of myo-inositol (units: i.u.)	Through study completion (approximately 1 month)
Secondary	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.	Through study completion (approximately 1 month)
Secondary	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.	Throughout intervention (approximately 17 hours)
Secondary	Change in Shame Inventory rating from baseline to post intervention	The Shame Inventory assess participants' feelings related to shame. Units: scale.	Through study completion (approximately 1 month)
Secondary	Change in Shame Inventory rating during intervention	The Shame Inventory assess participants' feelings related to shame. Units: scale.	Throughout intervention (approximately 17 hours)
Secondary	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.	Through study completion (approximately 1 month)
Secondary	Change in Anxiety Sensitivity Index (ASI-3) rating during intervention	The Anxiety Sensitivity Index assess participants' concern related to anxiety.Units: scale.	Throughout intervention (approximately 17 hours)
Secondary	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.	Through study completion (approximately 1 month)
Secondary	Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention	The Depression, Anxiety, and Stress Scale assesses participants emotional states. Units: scale.	Throughout intervention (approximately 17 hours)
Secondary	Patient health questionnaire (PHQ-9)	This patient health questionnaire is used to compute a general depression score.Units: scale.	Pre-enrollment