NCT04279522

The MOOD Study - External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the Treatment of Major Depressive Disorder (MDD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Neurolief Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• MDD

Interventions

Type	Name	Description
DEVICE	Relivion®DP- Active	Relivion®DP- Active stimulation device
DEVICE	Relivion®DP- Sham	Relivion®DP- Sham stimulation device

Timeline

• Start date: 2021-08-31
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2020-02-21
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

13 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study