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Major DepressionNCT05497414

Neuroimaging Sleep and Mood in Depression

A study testing Sleep deprivation in people with Major Depression, run by Boston University Charles River Campus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Major Depression
What is being tested?
Sleep deprivation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited States
Study dates
31 Jan 2022to 15 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston University

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Sleep deprivation
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep deprivationBehavioural

    Overnight sleep deprivation.

Study groups in NCT05497414
Study groupRoleWhat they receive
Sleep deprivedExperimentalOvernight sleep deprivation
Receives: Behavioral: Sleep deprivation
RestedNo interventionWell-rested sleep pattern

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    fMRI signal (units: %)

    Measured: Through study completion (approximately 1 month)

  2. Change in fMRI signals in amygdala ROI from baseline to post intervention

    fMRI signal (units: %)

    Measured: Through study completion (approximately 1 month)

  3. Change in tasked evoked responses in amygdala ROI from baseline to post intervention

    Task evoked responses in amygdala ROI (units: %)

    Measured: Through study completion (approximately 1 month)

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

    Fluid flow measured with MRI (units: %)

    Measured: Through study completion (approximately 1 month)

  5. Change in Montgomery-Asberg Depression Rating from baseline to post intervention

    Mood scores, measured on scale of 0-60

    Measured: Through study completion (approximately 1 month)

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

    fMRI measure of hemodynamics (units: %)

    Measured: Through study completion (approximately 1 month)

Secondary outcomes (15)

  1. Change in EEG dynamics from baseline to post intervention

    Amplitude of EEG signals (units: uV^2)

    Measured: Through study completion (approximately 1 month)

  2. Change in dot probe task performance from baseline to post intervention

    Behavior on emotional task (units: ms)

    Measured: Through study completion (approximately 1 month)

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

    Blood analysis results (units: mg/L)

    Measured: Through study completion (approximately 1 month)

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

    Measured in pg/mL

    Measured: Through study completion (approximately 1 month)

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

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

    Measured: Through study completion (approximately 1 month)

  6. Change in MRS measurement of myo-inositol from baseline to post intervention

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

    Measured: Through study completion (approximately 1 month)

  7. 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.

    Measured: Through study completion (approximately 1 month)

  8. 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.

    Measured: Throughout intervention (approximately 17 hours)

  9. Change in Shame Inventory rating from baseline to post intervention

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

    Measured: Through study completion (approximately 1 month)

  10. Change in Shame Inventory rating during intervention

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

    Measured: Throughout intervention (approximately 17 hours)

  11. 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.

    Measured: Through study completion (approximately 1 month)

  12. Change in Anxiety Sensitivity Index (ASI-3) rating during intervention

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

    Measured: Throughout intervention (approximately 17 hours)

  13. 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.

    Measured: Through study completion (approximately 1 month)

  14. Change in Depression, Anxiety, and Stress Scale (DASS-21) rating during intervention

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

    Measured: Throughout intervention (approximately 17 hours)

  15. Patient health questionnaire (PHQ-9)

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

    Measured: Pre-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start31 Jan 2022
  3. Primary completion15 Mar 2024
  4. Study completion15 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Factorial
Model description
Two groups (healthy vs major depression) are studied under two conditions (rested vs sleep deprivation).
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497414
Sponsor's protocol ID
5562E
Status last verified
Jul 2026
First submitted
24 Feb 2022
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep deprivation in people with Major Depression, run by Boston University Charles River Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fMRI signals in thalamus region of interest (ROI) from baseline to post intervention (time frame: Through study completion (approximately 1 month)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05497414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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