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

Description

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.

Conditions

Treatment Resistant Depression

Study Overview

Study Details

Study overview

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

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
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Huntsville

UAB Huntsville Regional Medical Center, Huntsville, Alabama, United States, 35801

Burlingame

Access Multi Specialty Medical Clinic, Inc, Burlingame, California, United States, 94010

Colton

CMB Clinical Trials, Colton, California, United States, 92324

Costa Mesa

ATP Clinical Research, Inc., Costa Mesa, California, United States, 92626

La Jolla

Kaizen Brain Center, La Jolla, California, United States, 92037

Los Angeles

Keck Hospital of USC, Los Angeles, California, United States, 90033

San Diego

University of California San Diego, San Diego, California, United States, 92103

San Rafael

SF-CARE, Inc., San Rafael, California, United States, 94901

Santa Ana

Syrentis Clinical Research, Santa Ana, California, United States, 92705

Participation Criteria

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.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    LivaNova,

    Charles Conway, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

    Study Record Dates

    2030-12-31