Neurofeedback to Treat Depression - 2

NCT07159061 | Recruiting

• 1 other identifier: 849298-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD. This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS)

  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.

  3 months

Study Arms (2)

Active Comparator: Active Neurofeedback

ACTIVE COMPARATOR

R33 Phase: Three training sessions. Each training session contains 32 minutes of active neurofeedback runs.

Behavioral: Active Closed Loop Real Time fMRI Neurofeedback

Sham Comparator: Sham Neurofeedback

SHAM COMPARATOR

R33 Phase: Three training sessions. Each training session contains 32 minutes of sham (placebo) neurofeedback runs.

Behavioral: Sham Closed Loop Real Time fMRI Neurofeedback

Interventions

Active Closed Loop Real Time fMRI Neurofeedback BEHAVIORAL

Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)

Active Comparator: Active Neurofeedback

Sham Closed Loop Real Time fMRI Neurofeedback BEHAVIORAL

Sham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)

Sham Comparator: Sham Neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Center for Neuromodulation in Depression and Stress

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Yvette Sheline, M.D.

  Center for Neuromodulation in Depression and Stress, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvette Sheline, M.D.

CONTACT

(215) 746-2637; cndslab@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: McLure Professor of Radiology, Neurology and Psychiatry

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 8, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): November 21, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)