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Completed

NCT Number: NCT05169346

Neurofeedback to Treat Depression

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.

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Key information

Conditions

MDD

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neuromodulation in Depression and Stress

Philadelphia, Pennsylvania, 19104, United States

About this study

In both the R61and R33 phases we will compare cloud based real time fMRI feedback with placebo (sham feedback) in reducing negative attention bias and depressive symptoms. This study will be the first dose-finding test of real-time fMRI effect on negative attention bias. Measures include: Structured Clinical Interview for DSM-5 (SCID), Clinician-administered diagnostic exam, Montgomery Asberg Depression Rating Scale (MADRS), Clinician-administered scale used to assess the severity of depression, State-Trait Anxiety Inventory (STAI), Self-report questionnaire used to measure types of anxiety and mood symptoms, Mood and Anxiety Symptom Questionnaire (MASQ), Negative perseveration during a go/no-go task, Go/no-go task with overlaid face/scene stimuli; brain response triggers next stimulus, Negative gaze, Negative gaze collected in gaze data following each real time fMRI feedback session

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Closed Loop Real Time fMRI Neurofeedback

Behavioral

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

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)

Primary outcomes

  1. Attention Mechanism of Depression

    Time frame: 5 years

    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).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Reducing Neural Perseveration Through Closed Loop Real Time fMRI Neurofeedback to Alleviate Depressive Symptoms

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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