Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06735885

fMRI Neurofeedback With Matter Neuroscience App

Led by Stanford University · Updated on 2025-12-17

240

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

fMRI Neurofeedback With Matter Neuroscience App

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female between 18 and 80 years old at screening
  • Primary diagnosis of nonpsychotic major depressive disorder without psychotic features
  • Montgomery-Åsberg Depression Rating Scale (MADRS) score between 15 and 25
  • Able to read, understand, and provide written informed consent, with English proficiency to complete questionnaires and follow instructions
  • Possess an iPhone with the latest compatible iOS version and able to use the study app
  • History of 1 to 5 adequate antidepressant medication failures
  • Stable dose of primary antidepressant medication for 4 weeks before baseline and willing to continue throughout the study
  • In good general health as determined by medical history and study physician
  • Women of reproductive potential agree to use highly effective contraception during participation
  • Adequate vision (with or without corrective lenses) to view study materials in the MRI
  • Agree to adhere to lifestyle considerations throughout the study duration
Not Eligible

You will not qualify if you...

  • Contraindication to MRI such as ferromagnetic metal in the body
  • Severe claustrophobia
  • Pregnant, breastfeeding, positive pregnancy test, or planning pregnancy during the study
  • Primary psychiatric condition other than major depressive disorder requiring treatment, except stable anxiety disorder
  • History 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 signs of acute withdrawal
  • Positive urine test for recent recreational drug use
  • Considered at significant risk for suicide during the study
  • Recent or concurrent use of rapid acting antidepressant treatments like ECT or TMS, excluding ketamine
  • History of significant neurological diseases such as dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or significant head trauma
  • Untreated or insufficiently treated endocrine or metabolic disorders
  • Any condition deemed by the principal doctor to interfere with the study or increase participant risk
  • Alexithymia as determined by the Toronto Alexithymia Scale
  • Treatment with investigational drugs or other interventions during the study period
  • Not currently experiencing a major depressive episode as defined by the MINI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Stanford University Brain Stimulation Lab

Stanford, California, United States, 94304

Actively Recruiting

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Research Team

N

Nick Bassano, MS

CONTACT

N

Noriah Johnson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

8

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fMRI Neurofeedback With Matter Neuroscience App | DecenTrialz