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Recruiting NCT07159061

Neurofeedback to Treat Depression - 2

No phase Interventional Major Depressive Disorder (MDD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Closed Loop Real Time fMRI Neurofeedback, Sham Closed Loop Real Time fMRI Neurofeedback.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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

Interventions

  • Behavioral Active Closed Loop Real Time fMRI Neurofeedback
    Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
  • Behavioral 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 measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Center for Neuromodulation in Depression and Stress — Philadelphia

Identifiers

NCT: NCT07159061 · 849298-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗