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NCT Number: NCT07159061

Neurofeedback to Treat Depression - 2

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

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

Location status: Recruiting

Location contact

Maria Prociuk

CONTACT

[email protected]

(215) 573-4229

Yvette Sheline, MD

PRINCIPAL_INVESTIGATOR

About this study

The investigators 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. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yvette Sheline, M.D.

CONTACT

[email protected]

(215) 746-2637

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Dec 4, 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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