MDD Clinical Trial
Official title:
The MOOD Study - External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the Treatment of Major Depressive Disorder (MDD)
The MOOD study will evaluate the safety and efficacy of a noninvasive, self-administered external Combined Occipital and Trigeminal Neurostimulation (eCOT-NS) treatment for Major Depressive Disorder (Relivion®DP). This is a prospective, multi-center, 2-arm randomized, double-blind, parallel-group, sham-controlled study. The study will include the following stages: 1. Screening, Eligibility evaluation and Randomization to Relivion®DP vs. Sham control (1:1 randomization) (Baseline - Day 0). 2. Daily treatment period: Active/Sham (Group A/B) treatment protocol (Baseline to end of 8 weeks). 3. Open label phase: Active treatment period of additional 8 weeks. After completion of the open label period the subject's participation in the study will be over.
The study will include the following study visits & phases: - Visit 1- Screening (Day (-14)-0) - Screening & Preliminary Eligibility Assessment. - Visit 2- Baseline (Day (-4)-0) - Eligibility, baseline assessment, Randomization to Relivion®DP vs. Sham control (1:1 randomization) and training. - Double blind phase (Day 0 to day 56±7)- 5-7 days a week treatment: Active/Sham (Group A/B) treatment protocol. - Visit 3- Follow Up Visit (day 28±7)- MDD assessment. - Visit 4- End of Double-Blind phase (day 56±7)- MDD assessment. - Open label phase- Active treatment period: According to HDRS response in DB phase, in between Maintenance treatment 3-4 times a week and up to 5-7 days a week of intensified treatment (Day 56±7 to day 112±7) - Visit 5- follow up visit (day 84±7) - MDD assessment. - Visit 6- End of study (day 112±7)- MDD assessment and end of study. ;
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