Neurofeedback to Treat Depression

NCT05169346 | Completed

• 2 other identifiers: 849298R61MH128492
• Study Type: interventional
• Target: 71
• 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 (60 in R61 phase and 80 in R33 Phase). 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

MDD

Outcome Measures

Primary Outcomes (1)

• Attention Mechanism of Depression

  Associate neurofeedback related changes in our hypothesized attentional mechanism of depression (i.e. neural perseveration of negative states) with changes in depression severity as measured by the Montgomery Asberg Depression Rating Scale (MADRS).

  5 years

Study Arms (2)

Active Neurofeedback

ACTIVE COMPARATOR

R61 Phase: Three training sessions. Each training session contains 32 minutes of active neurofeedback runs. R33 Phase: Number of training sessions are contingent on R61 findings.

Behavioral: Active Closed Loop Real Time fMRI Neurofeedback

Sham Neurofeedback

SHAM COMPARATOR

R61 Phase: Three training sessions. Each training session contains 32 minutes of sham (placebo) neurofeedback runs. R33 Phase: Number of training sessions are contingent on R61 findings.

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 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 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
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Neuromodulation in Depression and Stress

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Yvette I Sheline, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: December 8, 2021
• First Posted: December 23, 2021
• Study Start: May 25, 2022
• Primary Completion: June 6, 2025
• Study Completion: June 13, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)