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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the safety and efficacy of neurofeedback for treating depression through MADRS scale changes
Timeframe: Screening, Baseline, Immediate Post, One Month Post, Three Month and Optional Six Month
. Has had at least one lifetime antidepressant treatment failure (ATHF)
. 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
Exclusion criteria
. 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.
. 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..