The MOOD Study - External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the Treatment of Major Depressive Disorder (MDD)
Public ClinicalTrials.gov record NCT04279522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04279522
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2021 (Actual)
- Primary completion
- Jun 7, 2024 (Actual)
- Completion
- Jun 7, 2024 (Actual)
- Last update posted
- Aug 12, 2025
2021 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | — |
| UCLA Semel Institute for Neuroscience and Behaviour | Los Angeles | California | 90024 | — |
| San Marcus Research Clinic | Miami Lakes | Florida | 33014 | — |
| K2 Medical Research Tampa | Tampa | Florida | 33607 | — |
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Sheppard Prat Health system | Baltimore | Maryland | 21204 | — |
| University of Minnesota | Minneapolis | Minnesota | 55416 | — |
| University of North Carolina, Department of Psychiatry | Chapel Hill | North Carolina | 27514 | — |
| Butler Hospital/Brown University | Providence | Rhode Island | 02906 | — |
| VA Providence Healthcare System | Providence | Rhode Island | 02908 | — |
| MUSC Institute of Psychiatry | Charleston | South Carolina | 29425 | — |
| Brain Health Consultants and TMS Center | Houston | Texas | 77046 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04279522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2025 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04279522 live on ClinicalTrials.gov.