Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
Start Date
6/25/2025
Completion Date
8/30/2027
Summary
The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting. During this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).
Detailed Description
The study is comprised of the Screening Visit, Baseline Assessment, Pre-training Visit, 20 NF Training Visits (two training visits per week over 10 weeks), two Booster NF Training Visits (Week 16, and Week 20, and the 3-Month Follow-up Assessment Visit (Week 24). Participants will receive 20 NF sessions. The study will test the following hypothesis: * H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP * H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP Where: M(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants. \*HDRS-21 is administered for cluster analysis
Eligibility Criteria
Age Range: 22 years to 75 years
Interventions
Prism Training
Conditions
Locations
Butler Hospital
Providence, Rhode Island 02906
United States
Houston Center For Advanced Psychiatric Treatment
Houston, Texas 77401
United States
Sheba Medical Center
Ramat Gan,
Israel