Neuroimaging Sleep and Mood in Depression

NCT05497414 | Unknown

• 1 other identifier: 5562E
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (6)

• Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention

  fMRI signal (units: %)

  Through study completion (approximately 1 month)

• Change in fMRI signals in amygdala ROI from baseline to post intervention

  fMRI signal (units: %)

  Through study completion (approximately 1 month)

• 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)

• Change in cerebrospinal fluid (CSF) flow measurements from baseline to post intervention

  Fluid flow measured with MRI (units: %)

  Through study completion (approximately 1 month)

• 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)

• Change in whole-brain voxelwise fMRI activity from baseline to post intervention

  fMRI measure of hemodynamics (units: %)

  Through study completion (approximately 1 month)

Secondary Outcomes (15)

• Change in EEG dynamics from baseline to post intervention

  Through study completion (approximately 1 month)

• Change in dot probe task performance from baseline to post intervention

  Through study completion (approximately 1 month)

• Change in blood biomarkers of C-reactive protein from baseline to post intervention

  Through study completion (approximately 1 month)

• Change in blood levels of Interleukin 6 from baseline to post intervention

  Through study completion (approximately 1 month)

• Change in Magnetic Resonance Spectroscopy (MRS) measurement of lactate from baseline to post intervention

  Through study completion (approximately 1 month)

Study Arms (2)

Sleep deprived

EXPERIMENTAL

Overnight sleep deprivation

Behavioral: Sleep deprivation

Rested

NO INTERVENTION

Well-rested sleep pattern

Interventions

Sleep deprivation BEHAVIORAL

Overnight sleep deprivation.

Sleep deprived

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 18-80
• \- Current diagnosis of major depressive disorder

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Laura Lewis, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dabriel Zimmerman, BS

CONTACT

803-347-6699; dabrielz@bu.edu

Stephanie Anakwe, BS

CONTACT

anakwes@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups (healthy vs major depression) are studied under two conditions (rested vs sleep deprivation).

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: August 11, 2022
• Study Start: January 31, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (1)