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Neurofeedback to Treat Depression - 2

NCT07159061 · University of Pennsylvania
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Reducing Neural Perseveration Through Closed Loop Real Time fMRI Neurofeedback to Alleviate Depressive Symptoms
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
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
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-11-21
Estimated completion: 2028-12-01
Last updated: 2025-12-04
Interventions
Behavioral: Active Closed Loop Real Time fMRI NeurofeedbackBehavioral: Sham Closed Loop Real Time fMRI Neurofeedback
Primary outcomes
  • Montgomery Asberg Depression Rating Scale (MADRS) (3 months)
Sponsor
University of Pennsylvania · other
Contacts & investigators
ContactYvette Sheline, M.D. · contact · cndslab@pennmedicine.upenn.edu · (215) 746-2637
InvestigatorYvette Sheline, M.D. · principal_investigator, Center for Neuromodulation in Depression and Stress, University of Pennsylvania
All locations (1)
Center for Neuromodulation in Depression and StressRecruiting
Philadelphia, Pennsylvania, United States
Neurofeedback to Treat Depression - 2 · TrialPath