Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2022-05-25
2025-06-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Neurofeedback
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.
Active Closed Loop Real Time fMRI Neurofeedback
Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
Sham Neurofeedback
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.
Sham Closed Loop Real Time fMRI Neurofeedback
Sham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Yvette Sheline
McLure Professor of Radiology, Neurology and Psychiatry
Principal Investigators
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Yvette I Sheline, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Center for Neuromodulation in Depression and Stress
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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849298
Identifier Type: -
Identifier Source: org_study_id
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