Depression MildNCT06735885
fMRI Neurofeedback With Matter Neuroscience App
A study testing Matter Neuroscience App, Stock Photos and No Home Training in people with Depression Mild and Depression, run by Stanford University at 1 site in United States.
Trial summary
Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression Mild, Depression, Depression Moderate
- What is being tested?
- Matter Neuroscience App, Stock Photos and No Home Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, between the ages of 18 and 80 at the time of screening.
- Primary diagnosis of nonpsychotic major depressive disorder (MDD) without a history of psychotic features.
- Score on the MADRS scale between 15-25
- Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- Must possess an iPhone with the latest iOS version compatible with the app or must be willing to use a loaner iPhone from the study if available.
- Has had at least one lifetime antidepressant treatment failure (ATHF)
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- The dose of the primary antidepressant medication (if applicable) must be stable for 4 weeks prior to baseline, and participants must agree to continue at this dose throughout the study period.
- In good general health, as evidenced by medical history and determined by study physician
- For women of reproductive potential: agree to the use of highly effective contraception during study participation.
- Adequate visual acuity (with or without corrective lenses) to view study materials while in the MRI.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
Who cannot join
- Contraindication to MRI (ferromagnetic metal in their body)
- Severe claustrophobia
- Women that are pregnant or breastfeeding or with a positive urine pregnancy test at participation, or who are planning to become pregnant during the study period.
- Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
- History of or current psychotic disorder, schizophrenia, psychosis, bipolar disorder, or severe borderline personality disorder.
- Diagnosis of intellectual disability, autism spectrum disorder, or other neurodevelopmental disorder.
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- Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
- Urine screening test positive for recent use of recreational drugs except for marijuana..
- Considered at significant risk for suicide during the course of the study.
- Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., a course of ECT or TMS). Excluding ketamine.
- History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma as determined by the PD.
- Untreated or insufficiently treated endocrine or metabolic disorder.
- Any other condition deemed by the PD to interfere with the study or increase risk to the participant
- Alexithymia as determined by the Toronto Alexithymia Scale
- Treatment with an investigational drug or other intervention within the study period.
- Not currently in a major depressive episode as defined by the MINI.
- More than 5 lifetime adequate antidepressant medication failures (ATHF).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University Brain Stimulation Lab
Stanford, California, 94304
Stephanie Wan, 650-491-6339, stephwan@stanford.edu
Nick Bassano, MSW, 650-800-6920, nbassano@stanford.edu
About this study
Official title: Stanford-Matter Neuroscience High-Resolution fMRI Advanced Neurofeedback Feasibility Trial (fMRI Neurofeedback) Medical
Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial.
Read the detailed description
The Matter Neuroscience application, available through the Apple App Store, is designed to help users understand positive emotions and the neurotransmitters that create them. The application allows users to collect good moments by adding photos and other information to the application and activating positive emotions when the photos and other information are viewed. When positive emotions are activated, the application allows users to quickly rate the positive emotions felt during moments. The data collected is translated into the user's Matter Score. Tracking the user's Matter Score can allow them to see how they are doing from the inside out. Neurotransmitter activity helps build neuroplasticity in the brain. Higher levels of neuroplasticity correlate with higher levels of creativity, intelligence, and empathy as well as longer, healthier, happier lifespans. The 7TMRI Scanner will be used to gather structural and functional brain data.
- Conditions
- Depression Mild, Depression, Depression Moderate
- Being tested
- Matter Neuroscience App, Stock Photos, No Home Training, Personal Photos, Home Training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matter Neuroscience AppDevice
An iPhone smartphone application
Stock PhotosOther
Stock Photos
No Home TrainingOther
No Home Training
Personal PhotosOther
Personal Photos
Home TrainingOther
Home Training
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A. No home training, no neurofeedback, no photos, no repeated scans | No intervention | No home training, no neurofeedback, no photos, no repeated scans |
| Arm 1B. No home training no neurofeedback, repeated scans, personal photos | Experimental | No home training no neurofeedback, repeated scans, personal photos Receives: Device: Matter Neuroscience App; Other: No Home Training; Other: Personal Photos |
| Arm 2. No home training, neurofeedback, stock photos, repeated scans | Experimental | No home training, neurofeedback, stock photos, repeated scans Receives: Device: Matter Neuroscience App; Other: Stock Photos; Other: No Home Training |
| Arm 3. No home training, neurofeedback, personal photos, repeated scans | Experimental | No home training, neurofeedback, personal photos, repeated scans Receives: Device: Matter Neuroscience App; Other: No Home Training; Other: Personal Photos |
| Arm 4. Home training, no neurofeedback, stock photos, repeated scans | Experimental | Home training, no neurofeedback, stock photos, repeated scans Receives: Device: Matter Neuroscience App; Other: Stock Photos; Other: Home Training |
| Arm 5. Home training, neurofeedback, stock photos, repeated scans | Experimental | Home training, neurofeedback, stock photos, repeated scans Receives: Device: Matter Neuroscience App; Other: Stock Photos; Other: Home Training |
| Arm 6. Home training, no neurofeedback, personal photos, repeated scans | Experimental | Home training, no neurofeedback, personal photos, repeated scans Receives: Device: Matter Neuroscience App; Other: Personal Photos; Other: Home Training |
| Arm 7. Home training, neurofeedback, personal photos, repeated scans | Experimental | Home training, neurofeedback, personal photos, repeated scans Receives: Device: Matter Neuroscience App; Other: Personal Photos; Other: Home Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes
Determine the safety and efficacy of neurofeedback for treating depression through MADRS (Montgomery-Åsberg Depression Rating Scale) scale changes.
The 9-item self-report version of the MADRS has an overall score range from 0-27, with higher scores corresponding to higher levels of depression.
Measured: Screening, Baseline, Immediate Post, One Month Post, Three Month and Optional Six Month
Secondary outcomes (1)
Measure fMRI Change
Measure fMRI Change
Measured: Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post Scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start12 Aug 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression MildStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, MD, Principal investigator, Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735885
- Sponsor's protocol ID
- 77871
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford-Matter Neuroscience High-Resolution fMRI Advanced Neurofeedback Feasibility Trial (fMRI Neurofeedback) Medical
- ClinicalTrials.gov ID
- NCT06735885
- Acronym / sponsor ID
- 77871
- Conditions
- Depression Mild, Depression, Depression Moderate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 16 Dec 2024 (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.
Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial.
Detailed description
The Matter Neuroscience application, available through the Apple App Store, is designed to help users understand positive emotions and the neurotransmitters that create them. The application allows users to collect good moments by adding photos and other information to the application and activating positive emotions when the photos and other information are viewed. When positive emotions are activated, the application allows users to quickly rate the positive emotions felt during moments. The data collected is translated into the user's Matter Score. Tracking the user's Matter Score can allow them to see how they are doing from the inside out. Neurotransmitter activity helps build neuroplasticity in the brain. Higher levels of neuroplasticity correlate with higher levels of creativity, intelligence, and empathy as well as longer, healthier, happier lifespans. The 7TMRI Scanner will be used to gather structural and functional brain data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arm 1A. No home training, no neurofeedback, no photos, no repeated scans | No intervention | –No home training, no neurofeedback, no photos, no repeated scans |
| Arm 1B. No home training no neurofeedback, repeated scans, personal photos | Experimental | Device: Matter Neuroscience App, Other: No Home Training, Other: Personal PhotosNo home training no neurofeedback, repeated scans, personal photos |
| Arm 2. No home training, neurofeedback, stock photos, repeated scans | Experimental | Device: Matter Neuroscience App, Other: Stock Photos, Other: No Home TrainingNo home training, neurofeedback, stock photos, repeated scans |
| Arm 3. No home training, neurofeedback, personal photos, repeated scans | Experimental | Device: Matter Neuroscience App, Other: No Home Training, Other: Personal PhotosNo home training, neurofeedback, personal photos, repeated scans |
| Arm 4. Home training, no neurofeedback, stock photos, repeated scans | Experimental | Device: Matter Neuroscience App, Other: Stock Photos, Other: Home TrainingHome training, no neurofeedback, stock photos, repeated scans |
| Arm 5. Home training, neurofeedback, stock photos, repeated scans | Experimental | Device: Matter Neuroscience App, Other: Stock Photos, Other: Home TrainingHome training, neurofeedback, stock photos, repeated scans |
| Arm 6. Home training, no neurofeedback, personal photos, repeated scans | Experimental | Device: Matter Neuroscience App, Other: Personal Photos, Other: Home TrainingHome training, no neurofeedback, personal photos, repeated scans |
| Arm 7. Home training, neurofeedback, personal photos, repeated scans | Experimental | Device: Matter Neuroscience App, Other: Personal Photos, Other: Home TrainingHome training, neurofeedback, personal photos, repeated scans |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female, between the ages of 18 and 80 at the time of screening.
- Primary diagnosis of nonpsychotic major depressive disorder (MDD) without a history of psychotic features.
- Score on the MADRS scale between 15-25
- Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- Must possess an iPhone with the latest iOS version compatible with the app or must be willing to use a loaner iPhone from the study if available.
Key exclusion criteria (17 listed)
- Contraindication to MRI (ferromagnetic metal in their body)
- Severe claustrophobia
- Women that are pregnant or breastfeeding or with a positive urine pregnancy test at participation, or who are planning to become pregnant during the study period.
- Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
- History of or current psychotic disorder, schizophrenia, psychosis, bipolar disorder, or severe borderline personality disorder.
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 |
|---|---|---|
| Matter Neuroscience AppAn iPhone smartphone application | Device | Arm 1B. No home training no neurofeedback, repeated scans, personal photos, Arm 2. No home training, neurofeedback, stock photos, repeated scans, Arm 3. No home training, neurofeedback, personal photos, repeated scans, Arm 4. Home training, no neurofeedback, stock photos, repeated scans, Arm 5. Home training, neurofeedback, stock photos, repeated scans, Arm 6. Home training, no neurofeedback, personal photos, repeated scans, Arm 7. Home training, neurofeedback, personal photos, repeated scans |
| Stock PhotosStock Photos | Other | Arm 2. No home training, neurofeedback, stock photos, repeated scans, Arm 4. Home training, no neurofeedback, stock photos, repeated scans, Arm 5. Home training, neurofeedback, stock photos, repeated scans |
| No Home TrainingNo Home Training | Other | Arm 1B. No home training no neurofeedback, repeated scans, personal photos, Arm 2. No home training, neurofeedback, stock photos, repeated scans, Arm 3. No home training, neurofeedback, personal photos, repeated scans |
| Personal PhotosPersonal Photos | Other | Arm 1B. No home training no neurofeedback, repeated scans, personal photos, Arm 3. No home training, neurofeedback, personal photos, repeated scans, Arm 6. Home training, no neurofeedback, personal photos, repeated scans, Arm 7. Home training, neurofeedback, personal photos, repeated scans |
| Home TrainingHome Training | Other | Arm 4. Home training, no neurofeedback, stock photos, repeated scans, Arm 5. Home training, neurofeedback, stock photos, repeated scans, Arm 6. Home training, no neurofeedback, personal photos, repeated scans, Arm 7. Home training, neurofeedback, personal photos, repeated scans |
Primary outcome
Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes
Time frame: Screening, Baseline, Immediate Post, One Month Post, Three Month and Optional Six Month
Determine the safety and efficacy of neurofeedback for treating depression through MADRS (Montgomery-Åsberg Depression Rating Scale) scale changes. The 9-item self-report version of the MADRS has an overall score range from 0-27, with higher scores corresponding to higher levels of depression.
1 secondary outcome
Measure fMRI Change
Time frame: Baseline, Week 2, Week 4, Week 6, Immediate Post, Optional Three Month Post Scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
David Spiegel, MD principal investigator
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matter Neuroscience App, Stock Photos and No Home Training in people with Depression Mild and Depression, run by Stanford University 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Wan (650 491 6339, stephwan@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes (time frame: Screening, Baseline, Immediate Post, One Month Post, Three Month and Optional Six Month). 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 6 Jul 2026.