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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.
Butler Hospital
Providence, Rhode Island, United States
RECRUITINGHouston Center For Advanced Psychiatric Treatment
Houston, Texas, United States
RECRUITINGSheba Medical Center
Ramat Gan, Israel
RECRUITINGHDRS-21
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
Time frame: Change from baseline to week 12 (post training visit)
SHAPS-C
Snaith-Hamilton-Pleasure scale - is a 14- item self-administered measure of anhedonia symptoms.
Time frame: Change from baseline to week 12 (post-training visit)
HDRS-21
Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.
Time frame: Change from baseline to 3-month FU visit
CGI-I
Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Time frame: Change from baseline to week 12 (post-training visit)
CGI-I
Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment.
Time frame: Change from week 12 to 3-Month follow-up Assessment
PHQ-9
Patient Health Questionnaire-9 - The PHQ-9 is a nine-item depressive symptom diagnostic tool.
Time frame: Change from baseline to week 12 (post-Training visit)
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