● Recruiting

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Condition: Treatment Resistant Depression · Sponsor: LivaNova

PhaseNA

Planned participants6800

Who can joinAll sexes, 18 Years to no upper limit

Healthy volunteersNo

About this study

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

This description comes directly from the study's public registry record.

Talk to the study team

Laura Yates, BSN · 281-228-7200 · laura.yates@livanova.com

Always discuss trial participation with your own doctor first.

Locations (101)

University of Alabama at Birmingham	Birmingham, Alabama, United States	Recruiting
UAB Huntsville Regional Medical Center	Huntsville, Alabama, United States	Recruiting
Access Multi Specialty Medical Clinic, Inc	Burlingame, California, United States	Terminated
CMB Clinical Trials	Colton, California, United States	Withdrawn
ATP Clinical Research, Inc.	Costa Mesa, California, United States	Recruiting
Kaizen Brain Center	La Jolla, California, United States	Recruiting
Keck Hospital of USC	Los Angeles, California, United States	Recruiting
University of California San Diego	San Diego, California, United States	Active Not Recruiting
SF-CARE, Inc.	San Rafael, California, United States	Terminated
Syrentis Clinical Research	Santa Ana, California, United States	Withdrawn
Sunrise Research Institute	Boca Raton, Florida, United States	Terminated
Mindful Behavioral Health	Boca Raton, Florida, United States	Recruiting

+ 89 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03887715