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.
Treatment Resistant Depression
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.
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
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University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294
UAB Huntsville Regional Medical Center, Huntsville, Alabama, United States, 35801
Access Multi Specialty Medical Clinic, Inc, Burlingame, California, United States, 94010
CMB Clinical Trials, Colton, California, United States, 92324
ATP Clinical Research, Inc., Costa Mesa, California, United States, 92626
Kaizen Brain Center, La Jolla, California, United States, 92037
Keck Hospital of USC, Los Angeles, California, United States, 90033
University of California San Diego, San Diego, California, United States, 92103
SF-CARE, Inc., San Rafael, California, United States, 94901
Syrentis Clinical Research, Santa Ana, California, United States, 92705
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
LivaNova,
Charles Conway, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine
2030-12-31