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

Part of paid clinical trials in La Jolla, California.

Sponsor
Neurolief Ltd.
Study ID
NCT04279522
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Relivion®DP- Active — DEVICE
    Relivion®DP- Active stimulation device
  • Relivion®DP- Sham — DEVICE
    Relivion®DP- Sham stimulation device

Study Details

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.

Key Dates

Start date
Aug 31, 2021
Status verified
Jul 2025
Primary completion
Jun 7, 2024
Completion
Jun 7, 2024

Study Design

Enrollment
124 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - active stimulation
  • Placebo Comparator: Group 2 - sham stimulation

Primary Outcome Measure

Mean Change in Depressive Symptoms, Measured by HDRS17 Total Score [ Time Frame: 8 weeks from treatment initiation ]

Locations (12)

FacilityCityStateZIPSite coordinators
Kadima Neuropsychiatry InstituteLa JollaCalifornia92037-
UCLA Semel Institute for Neuroscience and BehaviourLos AngelesCalifornia90024-
San Marcus Research ClinicMiami LakesFlorida33014-
K2 Medical Research TampaTampaFlorida33607-
Northwestern University, Feinberg School of MedicineChicagoIllinois60611-
Sheppard Prat Health systemBaltimoreMaryland21204-
University of MinnesotaMinneapolisMinnesota55416-
University of North Carolina, Department of PsychiatryChapel HillNorth Carolina27514-
Butler Hospital/Brown UniversityProvidenceRhode Island02906-
VA Providence Healthcare SystemProvidenceRhode Island02908-
MUSC Institute of PsychiatryCharlestonSouth Carolina29425-
Brain Health Consultants and TMS CenterHoustonTexas77046-

Find similar trials in La Jolla, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Kadima Neuropsychiatry Institute· La Jolla, CAUCLA Semel Institute for Neuroscience and Behaviour· Los Angeles, CASan Marcus Research Clinic· Miami Lakes, FLK2 Medical Research Tampa· Tampa, FLNorthwestern University, Feinberg School of Medicine· Chicago, ILSheppard Prat Health system· Baltimore, MD

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