Major Depressive DisorderNCT05933148
Network Neurofeedback Using 7-Tesla MRI to Reduce Rumination Levels in Depression
A study testing Siemens 7T MRI in people with Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Patients with major depressive disorder (MDD) exhibit increased levels of rumination (i.e. repetitive thinking and focus on negative mood states) which have been found to increase the risk of depressive relapse. The ability to reduce rumination levels among these patients is greatly needed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Siemens 7T MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2023to Dec 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 years who either meet DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI) for major depressive disorder (MDD) with a current major depressive episode OR does not meet for any current or past psychiatric diagnoses
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process
Who cannot join
- Any current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder for patients, active substance use disorder within the past 6 months
- Unstable medical illness, concomitant use of any medication with central nervous system activity within 1 week of MRI scan
- Pregnancy
- Patients who are currently hospitalized in the inpatient psychiatric units at Mount Sinai Hospital or involuntarily admitted/court-ordered
- Subjects judged to be at serious and imminent suicidal or homicidal risk by the study-affiliated psychiatrist or another MD, and contradictions to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School Of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Network-based Real-time Neurofeedback Using Ultra-high Field MRI to Reduce Rumination Levels in Depression
Patients with major depressive disorder (MDD) exhibit increased levels of rumination (i.e. repetitive thinking and focus on negative mood states) which have been found to increase the risk of depressive relapse. The ability to reduce rumination levels among these patients is greatly needed. Rumination is known to be associated with the default mode network (DMN) region activity. Implementing the Dependency Network Analysis (DEPNA), a recently developed method by the research team to quantify the connectivity influence of network nodes, found that rumination was significantly associated with lower connectivity influence of the left medial orbitofrontal cortex (MOFC) on the right precuneus, both key regions within the DMN. This study implements the first real-time fMRI neurofeedback (Rt-fMRI-NF) network-based protocol for up-regulation of the MOFC influence on the precuneus in patients with MDD to reduce rumination levels. This will allow for more accurate explicit brain connections modulation than the standard single brain region activity; creating a larger opportunity for target clinical neuromodulation treatment in individuals with MDD.
Read the detailed description
Major depressive disorder (MDD) is the world's largest health problem, and current available treatments fail at relieving symptoms for many patients. Rumination, which is conceptualized as repetitive thinking and focus on one's distress and negative mood states is a core feature of MDD. Patients with MDD exhibit increased levels of rumination which have been found to increase the risk of depressive relapse in remitted patients. The ability to reduce rumination levels among these patients is greatly needed.
Neurofeedback (NF) is a technique that feeds back information about brain signals to the individual in real-time, to allow for implicit modulation of the brain signal in order to improve performance. Yet, classic real-time fMRI-NF protocols focus on single region activity neglecting to consider the neural network dynamics, accounting for direct influences between regions.
Implementing the Dependency Network Analysis (DEPNA), a method developed by the research team, tested whether network connectivity influences during resting-state functional MRI (fMRI) are associated with rumination in patients with MDD. The research team found that rumination was significantly associated with lower connectivity influence of the left medial orbito-frontal cortex (MOFC) on the right precuneus, both key regions within the DMN. This is in line with intracranial recordings studies showing that MOFC activity precedes the precuneus in response to emotional stimuli.
The research team intend to extend this work by conducting the first real-time fMRI neurofeedback (Rt-fMRINF) protocol for up-regulation of the MOFC influence on the precuneus in patients with MDD and healthy controls to reduce rumination levels. The research team aims to develop an advanced ultra-high field MRI protocol that will allow for rt-fMRI-NF derived from networks' connectivity features as constructed by the DEPNA, and thus training the subject to control explicit brain connections. Specifically, the research team aims to train MDD patients to better regulate rumination levels by upregulating the influence of the MOFC on the precuneus.
- Conditions
- Major Depressive Disorder
- Being tested
- Siemens 7T MRI, Sham Neurofeedback
- 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.
Siemens 7T MRIDevice
Also called fMRI
The active neurofeedback session will be done within the 7T MRI.
Sham NeurofeedbackDevice
The sham Neurofeedback resembles the active condition but participants will not see their own brain activity and will instead view a past participant's active feedback from their same population group.
| Study group | Role | What they receive |
|---|---|---|
| Active Neurofeedback | Active comparator | Participants randomized to Active neurofeedback will receive real-time data depicting MOFC-precuneus brain activity while in the scanner. Receives: Device: Siemens 7T MRI |
| Sham Neurofeedback | Sham comparator | Participants randomized to the Sham neurofeedback control group will receive the feedback of a prior scanned participant's active MOFC-precuneus up-regulation and not their own brain activity. This condition will still visually resemble the active conditions. Receives: Device: Sham Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. Total scores on the RSS can range from 22 to 88, with higher scores corresponding to higher levels of rumination.
Measured: Pre-Neurofeedback (day 0) and Post-Neurofeedback (MRI assessment day 1)
Secondary outcomes (16)
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. Total scores on the RSS can range from 22 to 88, with higher scores corresponding to higher levels of rumination.
Measured: Pre-MRI Scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. Total scores on the RSS can range from 22 to 88, with higher scores corresponding to higher levels of rumination.
Measured: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. Total scores on the RSS can range from 22 to 88, with higher scores corresponding to higher levels of rumination.
Measured: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. Total scores on the RSS can range from 22 to 88, with higher scores corresponding to higher levels of rumination.
Measured: Post-MRI scan at follow up visit day 30
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress
Measured: Pre-MRI Scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress
Measured: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress
Measured: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress
Measured: Post-MRI scan at follow up visit day 30
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Total QIDS scores range from 0 to 27 with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression
Measured: Pre-MRI scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Total QIDS scores range from 0 to 27 with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression
Measured: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Total QIDS scores range from 0 to 27 with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression
Measured: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Total QIDS scores range from 0 to 27 with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression
Measured: Post-MRI scan at follow up visit day 30
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Each of the 10 items is rated on a scale of 0 to 6. These individual item scores are added together to form a total score, which can range between 0 and 60 points; higher scores indicated increased depression severity
Measured: Pre-MRI scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Each of the 10 items is rated on a scale of 0 to 6. These individual item scores are added together to form a total score, which can range between 0 and 60 points; higher scores indicated increased depression severity
Measured: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Each of the 10 items is rated on a scale of 0 to 6. These individual item scores are added together to form a total score, which can range between 0 and 60 points; higher scores indicated increased depression severity
Measured: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Each of the 10 items is rated on a scale of 0 to 6. These individual item scores are added together to form a total score, which can range between 0 and 60 points; higher scores indicated increased depression severity
Measured: Post-MRI scan at follow up visit day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start12 Jul 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Technical problem with the MRI machine post processing in real-time. A new 7T MRI scanner will be installed by January 2027.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind sham-controlled randomized trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Jacob, Icahn School of Medicine at Mount Sinai
- Investigators
- Yael Jacob, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933148
- Sponsor's protocol ID
- STUDY-22-00048
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not applicable to the aims of the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network-based Real-time Neurofeedback Using Ultra-high Field MRI to Reduce Rumination Levels in Depression
- ClinicalTrials.gov ID
- NCT05933148
- Acronym / sponsor ID
- STUDY-22-00048
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Technical problem with the MRI machine post processing in real-time. A new 7T MRI scanner will be installed by January 2027.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with major depressive disorder (MDD) exhibit increased levels of rumination (i.e. repetitive thinking and focus on negative mood states) which have been found to increase the risk of depressive relapse. The ability to reduce rumination levels among these patients is greatly needed. Rumination is known to be associated with the default mode network (DMN) region activity. Implementing the Dependency Network Analysis (DEPNA), a recently developed method by the research team to quantify the connectivity influence of network nodes, found that rumination was significantly associated with lower connectivity influence of the left medial orbitofrontal cortex (MOFC) on the right precuneus, both key regions within the DMN. This study implements the first real-time fMRI neurofeedback (Rt-fMRI-NF) network-based protocol for up-regulation of the MOFC influence on the precuneus in patients with MDD to reduce rumination levels. This will allow for more accurate explicit brain connections modulation than the standard single brain region activity; creating a larger opportunity for target clinical neuromodulation treatment in individuals with MDD.
Detailed description
Major depressive disorder (MDD) is the world's largest health problem, and current available treatments fail at relieving symptoms for many patients. Rumination, which is conceptualized as repetitive thinking and focus on one's distress and negative mood states is a core feature of MDD. Patients with MDD exhibit increased levels of rumination which have been found to increase the risk of depressive relapse in remitted patients. The ability to reduce rumination levels among these patients is greatly needed.
Neurofeedback (NF) is a technique that feeds back information about brain signals to the individual in real-time, to allow for implicit modulation of the brain signal in order to improve performance. Yet, classic real-time fMRI-NF protocols focus on single region activity neglecting to consider the neural network dynamics, accounting for direct influences between regions.
Implementing the Dependency Network Analysis (DEPNA), a method developed by the research team, tested whether network connectivity influences during resting-state functional MRI (fMRI) are associated with rumination in patients with MDD. The research team found that rumination was significantly associated with lower connectivity influence of the left medial orbito-frontal cortex (MOFC) on the right precuneus, both key regions within the DMN. This is in line with intracranial recordings studies showing that MOFC activity precedes the precuneus in response to emotional stimuli.
The research team intend to extend this work by conducting the first real-time fMRI neurofeedback (Rt-fMRINF) protocol for up-regulation of the MOFC influence on the precuneus in patients with MDD and healthy controls to reduce rumination levels. The research team aims to develop an advanced ultra-high field MRI protocol that will allow for rt-fMRI-NF derived from networks' connectivity features as constructed by the DEPNA, and thus training the subject to control explicit brain connections. Specifically, the research team aims to train MDD patients to better regulate rumination levels by upregulating the influence of the MOFC on the precuneus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-blind sham-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Active Neurofeedback | Active comparator | Device: Siemens 7T MRIParticipants randomized to Active neurofeedback will receive real-time data depicting MOFC-precuneus brain activity while in the scanner. |
| Sham Neurofeedback | Sham comparator | Device: Sham NeurofeedbackParticipants randomized to the Sham neurofeedback control group will receive the feedback of a prior scanned participant's active MOFC-precuneus up-regulation and not their own brain activity. This condition will still visually resemble the active conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18-65 years who either meet DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI) for major depressive disorder (MDD) with a current major depressive episode OR does not meet for any current or past psychiatric diagnoses
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process
Key exclusion criteria (5 listed)
- Any current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder for patients, active substance use disorder within the past 6 months
- Unstable medical illness, concomitant use of any medication with central nervous system activity within 1 week of MRI scan
- Pregnancy
- Patients who are currently hospitalized in the inpatient psychiatric units at Mount Sinai Hospital or involuntarily admitted/court-ordered
- Subjects judged to be at serious and imminent suicidal or homicidal risk by the study-affiliated psychiatrist or another MD, and contradictions to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siemens 7T MRIAlso: fMRIThe active neurofeedback session will be done within the 7T MRI. | Device | Active Neurofeedback |
| Sham NeurofeedbackThe sham Neurofeedback resembles the active condition but participants will not see their own brain activity and will instead view a past participant's active feedback from their same population group. | Device | Sham Neurofeedback |
Primary outcome
Change in Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Time frame: Pre-Neurofeedback (day 0) and Post-Neurofeedback (MRI assessment day 1)
The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. Total scores on the RSS can range from 22 to 88, with higher scores corresponding to higher levels of rumination.
16 secondary outcomes
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Time frame: Pre-MRI Scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Time frame: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Time frame: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Time frame: Post-MRI scan at follow up visit day 30
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
Time frame: Pre-MRI Scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
Time frame: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
Time frame: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)
Time frame: Post-MRI scan at follow up visit day 30
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Pre-MRI scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Post-MRI scan at follow up visit day 30
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Pre-MRI scan at screening (day 0)
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Post-MRI scan at follow up visit 24 hours
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Post-MRI scan at follow up visit day 7
Self-reported rumination related to negative affect as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Post-MRI scan at follow up visit day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. Not applicable to the aims of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Jacob, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siemens 7T MRI in people with Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai 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 5 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: paused, as of the sponsor's last update on 15 Jun 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS) (time frame: Pre-Neurofeedback (day 0) and Post-Neurofeedback (MRI assessment day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.