Recruiting

Neurofeedback

Sponsor:

Stanford University

Code:

NCT06735885

Conditions

Depression Mild

Depression

Depression Moderate

Eligibility Criteria

Sex: All

Age: 18 - 80

Healthy Volunteers: Not accepted

Interventions

Matter Neuroscience App

Stock Photos

No Home Training

Personal Photos

Home Training

Study Details

Brief 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.

Conditions

Depression Mild

Depression

Depression Moderate

Study ID

NCT06735885

Start date

Aug 12, 2025

Status verified date

May, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 80

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or Female, between the ages of 18 and 80 at the time of screening.
2. Primary diagnosis of nonpsychotic major depressive disorder (MDD) without a history of psychotic features.
3. Score on the MADRS scale between 15-25
4. 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.
5. 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.
6. Has had at least one lifetime antidepressant treatment failure (ATHF)
7. 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.
8. In good general health, as evidenced by medical history and determined by study physician
9. For women of reproductive potential: agree to the use of highly effective contraception during study participation.
10. Adequate visual acuity (with or without corrective lenses) to view study materials while in the MRI.
11. Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria:

1. Contraindication to MRI (ferromagnetic metal in their body)
2. Severe claustrophobia
3. 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.
4. Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
5. History of or current psychotic disorder, schizophrenia, psychosis, bipolar disorder, or severe borderline personality disorder.
6. Diagnosis of intellectual disability, autism spectrum disorder, or other neurodevelopmental disorder.
7. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
8. Urine screening test positive for recent use of recreational drugs except for marijuana..
9. Considered at significant risk for suicide during the course of the study.
10. 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.
11. 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.
12. Untreated or insufficiently treated endocrine or metabolic disorder.
13. Any other condition deemed by the PD to interfere with the study or increase risk to the participant
14. Alexithymia as determined by the Toronto Alexithymia Scale
15. Treatment with an investigational drug or other intervention within the study period.
16. Not currently in a major depressive episode as defined by the MINI.
17. More than 5 lifetime adequate antidepressant medication failures (ATHF).

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Arm 1A. No home training, no neurofeedback, no photos, no repeated scans

No home training, no neurofeedback, no photos, no repeated scans

experimental: Arm 1B. No home training no neurofeedback, repeated scans, personal photos

No home training no neurofeedback, repeated scans, personal photos

experimental: Arm 2. No home training, neurofeedback, stock photos, repeated scans

No home training, neurofeedback, stock photos, repeated scans

experimental: Arm 3. No home training, neurofeedback, personal photos, repeated scans

No home training, neurofeedback, personal photos, repeated scans

experimental: Arm 4. Home training, no neurofeedback, stock photos, repeated scans

Home training, no neurofeedback, stock photos, repeated scans

experimental: Arm 5. Home training, neurofeedback, stock photos, repeated scans

Home training, neurofeedback, stock photos, repeated scans

experimental: Arm 6. Home training, no neurofeedback, personal photos, repeated scans

Home training, no neurofeedback, personal photos, repeated scans

experimental: Arm 7. Home training, neurofeedback, personal photos, repeated scans

Home training, neurofeedback, personal photos, repeated scans

Interventions

Matter Neuroscience App

An iPhone smartphone application

Stock Photos

Stock Photos

No Home Training

No Home Training

Personal Photos

Personal Photos

Home Training

Home Training

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 ]

Central Contacts and Locations

Locations

Stanford University Brain Stimulation Lab

Recruiting

Stanford, California, United States, 94304

Contacts

Principal Investigator:

David Spiegel, MD

More Information

Sponsor

Stanford University

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stanford University on 2026-05-26.