Real-time fMRI neurofeedback to reduce negative attention bias in depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults (18–65) with major depressive disorder and a minimum MADRS score of 16 will be randomized to receive either active closed-loop real-time fMRI neurofeedback or sham feedback. The system uses cloud-based pattern classification to decode each participant's attentional state in real time and dynamically change task stimuli in a closed loop. This is a first-in-human dose-finding test of real-time fMRI effects on negative attention bias, with measures including structured diagnostic interviews, MADRS, STAI, MASQ, go/no-go behavioral tasks with face/scene overlays, and gaze metrics. Participants must be medication-free and able to undergo MRI at the Center for Neuromodulation in Depression and Stress at the University of Pennsylvania.

Why it matters

Who can join: the full rules

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

Where it's running

• Center for Neuromodulation in Depression and Stress
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Yvette Sheline, M.D. — Center for Neuromodulation in Depression and Stress, University of Pennsylvania
• Study coordinator: Yvette Sheline, M.D.
• Email: cndslab@pennmedicine.upenn.edu
• Phone: (215) 746-2637

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.