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

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Conditions

Treatment Resistant DepressionVNSDepressionTRD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-26
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03887715

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Laura Yates, BSN
CONTACT
281-228-7200
laura.yates@livanova.com
Jeff Way, BS
CONTACT
281-228-7200
jeffrey.way@livanova.com

Principal Investigator

Charles Conway, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
UAB Huntsville Regional Medical Center
Huntsville, Alabama, 35801
United States
Access Multi Specialty Medical Clinic, Inc
Burlingame, California, 94010
United States
CMB Clinical Trials
Colton, California, 92324
United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
United States
Kaizen Brain Center
La Jolla, California, 92037
United States
Keck Hospital of USC
Los Angeles, California, 90033
United States
University of California San Diego
San Diego, California, 92103
United States
SF-CARE, Inc.
San Rafael, California, 94901
United States
Syrentis Clinical Research
Santa Ana, California, 92705
United States
Sunrise Research Institute
Boca Raton, Florida, 33325
United States
Mindful Behavioral Health
Boca Raton, Florida, 33431
United States
Medycal Research, Inc
Brooksville, Florida, 34609
United States
Galiz Research LLC
Hialeah, Florida, 33016
United States
Florida Behavioral Psych
Largo, Florida, 33770
United States
Segal Trials Corporate
Lauderhill, Florida, 33319
United States
Ocean Blue Medical Research Center
Miami Springs, Florida, 33166
United States
Central Miami Medical Institute, LLC
Miami, Florida, 33125
United States
Clintex Research Group, Inc.
Miami, Florida, 33135
United States
Research Center Of Florida, Inc
Miami, Florida, 33135
United States
APG Research, LLC
Orlando, Florida, 32803
United States
Nova Psychiatry Inc.
Orlando, Florida, 32803
United States
Florida Center for TMS
Orlando, Florida, 32806
United States
Millenia Psychiatry & Research, Inc
Orlando, Florida, 32819
United States
Quantum Laboratories Inc.
Pompano Beach, Florida, 33064
United States
Advanced Mental Health Care Inc.
Royal Palm Beach, Florida, 33411
United States
Florida Center for TMS
Saint Augustine, Florida, 94901
United States
Stedman Clinical Trials
Tampa, Florida, 33613
United States
Psychiatric Specialty Center
West Palm Beach, Florida, 33409
United States
Emory University
Atlanta, Georgia, 30322
United States
Medical College of Georgia, Augusta University
Augusta, Georgia, 30912
United States
PACT Atlanta LLC
Decatur, Georgia, 30030
United States
IACT Health
Grayson, Georgia, 30017
United States
Psych Atlanta
Marietta, Georgia, 30060
United States
Pearl Health Clinic
Ammon, Idaho, 83406
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Joliet Center For Clinical Research
Joliet, Illinois, 60435
United States
AMR- Baber Research, Inc.
Naperville, Illinois, 60563
United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, 60076
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
United States
Neuroscience Research Institute
Winfield, Illinois, 60910
United States
Advanced Research Institute, Inc.
Indianapolis, Indiana, 56268
United States
Beacon Medical Group Behavioral Health
South Bend, Indiana, 46601
United States
University Of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
Sheppard Pratt Health System, Inc.
Baltimore, Maryland, 21204
United States
Clinical Insights
Glen Burnie, Maryland, 21061
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, 48105
United States
University of Minnesota
Minneapolis, Minnesota, 55416
United States
Precise Research Centers
Flowood, Mississippi, 39232
United States
Andrew Bishop, MD
Jackson, Mississippi, 39216
United States
University of Missouri
Columbia, Missouri, 65212
United States
Psychiatric Care and Research
O'Fallon, Missouri, 633668
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
PsychCare Consultants Research
Saint Louis, Missouri, 63128
United States
Alivation Research, LLC
Lincoln, Nebraska, 68526
United States
Healthy Perspective
Nashua, New Hampshire, 03060
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
University of New Mexico - Psychiatric Center
Albuquerque, New Mexico, 87102
United States
Dent Neurological Institute
Amherst, New York, 14226
United States
Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
Buffalo, New York, 14215
United States
Trinity Medical
Lewiston, New York, 14092
United States
Hapworth Research Inc.
New York, New York, 10019
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Richmond Behavioral Associates
Staten Island, New York, 10312
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
State University Of New York Upstate Medical University
Syracuse, New York, 13210
United States
The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health
Cary, North Carolina, 27519
United States
Mindpath Care Centers
Raleigh, North Carolina, 27606
United States
Wake Forest University Health Science
Winston-Salem, North Carolina, 27103
United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Signature Research Associates, Inc.
Fairlawn, Ohio, 44333
United States
Charak Center for Health and Wellness
Garfield Heights, Ohio, 44125
United States
NPC Research
Oklahoma City, Oklahoma, 73109-3834
United States
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, 73112
United States
University of Oklahoma School of Community Medicine
Tulsa, Oklahoma, 74135
United States
Scranton Medical Institutes
Moosic, Pennsylvania, 18507
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Neuroscience and TMS Treatment Center
Brentwood, Tennessee, 37027
United States
UT Health Austin, Mulva Clinic for the Neurosciences
Austin, Texas, 78712
United States
BioBehavioral Research of Austin
Austin, Texas, 78759
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
Texas Tech University Health Science Center
El Paso, Texas, 79905
United States
The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders
Houston, Texas, 77054
United States
Houston Clinical Trials
Houston, Texas, 77401
United States
Northpointe Psychiatry
Lewisville, Texas, 75057
United States
Rise Clinical Research, LLC
Missouri City, Texas, 77459
United States
The University of Utah
Salt Lake City, Utah, 84108
United States
Neuropsychiatric Associates, Plc
Woodstock, Vermont, 05091
United States
Carilion Clinic
Roanoke, Virginia, 24014
United States
Center For Anxiety and Depression
Mercer Island, Washington, 98040
United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
United States
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, 25701
United States
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, 26506
United States
University of Wisconsin
Madison, Wisconsin, 53719
United States

Collaborators and Investigators

Sponsor: LivaNova

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-26
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2019-09-26
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • VNS
  • Depression
  • TRD

Additional Relevant MeSH Terms

  • Treatment Resistant Depression