Status:
RECRUITING
Neurofeedback to Treat Depression - 2
Lead Sponsor:
University of Pennsylvania
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 t...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07159061
Start Date
November 21 2025
End Date
December 1 2028
Last Update
December 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Neuromodulation in Depression and Stress
Philadelphia, Pennsylvania, United States, 19104