Recruiting

Neurofeedback Therapy

Sponsor:

University of Pennsylvania

Code:

NCT07159061

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active Closed Loop Real Time fMRI Neurofeedback

Sham Closed Loop Real Time fMRI Neurofeedback

Study Details

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)

Study ID

NCT07159061

Start date

Nov 21, 2025

Status verified date

Dec, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Nov 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Comparator: Active Neurofeedback

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

sham comparator: Sham Comparator: Sham Neurofeedback

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

Interventions

Active Closed Loop Real Time fMRI Neurofeedback

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

Sham Closed Loop Real Time fMRI Neurofeedback

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

Primary outcome measure

  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Yvette Sheline, M.D.

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

Locations

Center for Neuromodulation in Depression and Stress

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Maria Prociuk

(215) 573-4229lmari@pennmedicine.upenn.edu

Principal Investigator:

Yvette Sheline, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-12-04.