Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2025-08-12
2028-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 4. Home training, no neurofeedback, stock photos, repeated scans
Home training, no neurofeedback, stock photos, repeated scans
No interventions assigned to this group
Arm 5. Home training, neurofeedback, stock photos, repeated scans
Home training, neurofeedback, stock photos, repeated scans
No interventions assigned to this group
Arm 6. Home training, no neurofeedback, personal photos, repeated scans
Home training, no neurofeedback, personal photos, repeated scans
No interventions assigned to this group
Arm 7. Home training, neurofeedback, personal photos, repeated scans
Home training, neurofeedback, personal photos, repeated scans
No interventions assigned to this group
Arm 1A. No home training, no neurofeedback, no photos, no repeated scans, personal photos
No home training, no neurofeedback, no photos, no repeated scans, personal photos
No interventions assigned to this group
Arm 1B. No home training no neurofeedback, repeated scans
No home training no neurofeedback, repeated scans
No interventions assigned to this group
Arm 2. No home training, neurofeedback, stock photos, repeated scans
No home training, neurofeedback, stock photos, repeated scans
No interventions assigned to this group
Arm 3. No home training, neurofeedback, personal photos, repeated scans
No home training, neurofeedback, personal photos, repeated scans
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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, and be capable of using the study app with the phone.
6. 1-5 lifetime adequate antidepressant medication failures (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
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.
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.
18 Years
80 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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David Spiegel
Professor and Associate Chair of Psychiatry & Behavioral Sciences
Principal Investigators
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David Spiegel, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Locations
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Stanford University Brain Stimulation Lab
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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77871
Identifier Type: -
Identifier Source: org_study_id