fMRI Neurofeedback With Matter Neuroscience App

Not Applicable

Not yet recruiting

• Conditions: Depression Mild; Depression; Depression Moderate

• Registration Number: NCT06735885
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Study Start: 2025-06-15
• Primary Completion: 2027-06-15
• Study Completion: 2028-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Male or Female, between the ages of 18 and 80 at the time of screening.
2. 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.
3. Must possess an iPhone with iOS 17 or higher.
4. Single-SSRI-resistant depressive disorder patients with a MADRS scale between 20-34

Exclusion Criteria

1. Contraindication to MRI (ferromagnetic metal in their body)
2. Claustrophobia
3. Severe Major Depressive Disorder (MDD)
4. MADRS scale of >34
5. Treatment-resistant depression (TRD) from 3 or more treatments.
6. Any other condition deemed by the PD to interfere with the study or increase risk to the participant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine the safety and efficacy of neurofeedback for treating depression through MADRS (Montgomery-Åsberg Depression Rating Scale) scale changes.	12 months	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.