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Neurofeedback for Major Depressive Disorder

This study is testing a new approach called neurofeedback to help people with Major Depressive Disorder (MDD). It uses real-time fMRI (functional Magnetic Resonance Imaging) to show you your brain activity and help you learn to change how your brain responds to negative attention. The study compares this active neurofeedback with a sham (placebo) version to see if it can reduce negative attention bias and improve depression symptoms. To join, you need to be between 18 and 65 years old, have MDD, and score at least 16 on a depression severity scale (MADRS). The main goal is to see how much your depression symptoms improve after 3 months.

Study design
This interventional study plans to enroll 80 participants. It compares active neurofeedback with sham neurofeedback to see which is more effective.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be measured at 3 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07159061

Neurofeedback to Treat Depression - 2

Recruiting
NAAges 18–65InterventionalTreatment
University of Pennsylvania
~80 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Active Closed Loop Real Time fMRI NeurofeedbackSham Closed Loop Real Time fMRI Neurofeedback

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Montgomery Asberg Depression Rating Scale (MADRS)
Measured over 3 months

Conditions

Major Depressive Disorder (MDD)

Explore related trials

Unipolar Depression

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Yvette Sheline, M.D. · PRINCIPAL_INVESTIGATOR · Center for Neuromodulation in Depression and Stress, University of Pennsylvania

Who to contact

Yvette Sheline, M.D.
[email protected]
(215) 746-2637
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Gender, inclusive
Adult aged 18 - 65
Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD according to the Clinician-Administered MDD Scale for DSM-5 (unipolar depression or bipolar II depressed)
Scores at least a minimum score of 16 on Montgomery Asberg Depression Rating Scale (MADRS)
Normal cognition
Participants must be able to read and understand English
Participants must be able to provide consent

Exclusion

Pregnancy (female participants)
Outside age range
MRI contraindications (medical implant, claustrophobia, etc.)
Use of psychoactive medication (including antidepressants) or currently in therapy
Neurological disorder or any condition that in the view of the PI could impact brain data, cause depression, require medication that could cause depressive symptoms, or otherwise result in participant being unfit for study (for example, co-morbid psychotic, neurological disorders, developmentally or cognitively disabled/impaired, active alcohol or drug abuse/dependence within the past 6 months).
Non-English speaking
Non-correctable vision loss
Refusal to provide informed consent
representing an active suicide risk

What this trial measures

  • Montgomery Asberg Depression Rating Scale (MADRS)3 months

    Clinician administered scale to assess the severity of depression. MADRS scores will be compare the effect of real-time neurofeedback vs sham neurofeedback on depression outcome in patients with MDD. A MADRS score of 16 or higher is needed in order to be eligible to be enrolled in the study. The higher the MADRS score, the more depressed the individual will be. A lower MADRS score indicates that the individual's depressive symptoms have improved. A higher MADRS score indicates that the individual's depressive symptoms have worsened.