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

NCT04279522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-08-12

Study results available
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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.

Conditions

Interventions

DEVICE

Relivion®DP- Active

Relivion®DP- Active stimulation device

DEVICE

Relivion®DP- Sham

Relivion®DP- Sham stimulation device

Sponsors & Collaborators

  • Neurolief Ltd.

    lead INDUSTRY

Principal Investigators

  • Linda Carpenter, MD · Butler Hospital, Brown Department of Psychiatry and Human, RI, USA Behavior,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2024-06-07
Completion
2024-06-07
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04279522 on ClinicalTrials.gov