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

NARecruitingINTERVENTIONAL
Enrollment

6,800

Participants

Timeline

Start Date

September 26, 2019

Primary Completion Date

February 28, 2028

Study Completion Date

December 31, 2030

Conditions
Treatment Resistant Depression
Interventions
DEVICE

Vagus Nerve Stimulation (VNS)

VNS is an implantable device that delivers stimulation to the vagal nerve.

Trial Locations (98)

10019

RECRUITING

Hapworth Research Inc., New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10312

WITHDRAWN

Richmond Behavioral Associates, Staten Island

11794

TERMINATED

Stony Brook University Hospital, Stony Brook

11797

RECRUITING

ManuMind Interventional Psychiatry, Woodbury

13210

TERMINATED

State University Of New York Upstate Medical University, Syracuse

14092

RECRUITING

Trinity Medical, Lewiston

14215

WITHDRAWN

Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate, Buffalo

14226

RECRUITING

Dent Neurological Institute, Amherst

18507

RECRUITING

Scranton Medical Institutes, Moosic

19104

RECRUITING

University of Pennsylvania, Philadelphia

21061

WITHDRAWN

Clinical Insights, Glen Burnie

21204

RECRUITING

Sheppard Pratt Health System, Inc., Baltimore

24014

RECRUITING

Carilion Clinic, Roanoke

25701

RECRUITING

Marshall University Joan C. Edwards School of Medicine, Huntington

26506

WITHDRAWN

West Virginia Clinical and Translational Science Institute, Morgantown

27103

WITHDRAWN

Wake Forest University Health Science, Winston-Salem

27519

TERMINATED

The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health, Cary

27606

TERMINATED

Mindpath Care Centers, Raleigh

29425

RECRUITING

Medical University of South Carolina, Charleston

30017

WITHDRAWN

IACT Health, Grayson

30030

TERMINATED

PACT Atlanta LLC, Decatur

30060

RECRUITING

Psych Atlanta, Marietta

30322

RECRUITING

Emory University, Atlanta

30912

RECRUITING

Medical College of Georgia, Augusta University, Augusta

32803

RECRUITING

APG Research, LLC, Orlando

RECRUITING

Nova Psychiatry Inc., Orlando

32806

TERMINATED

Florida Center for TMS, Orlando

32819

WITHDRAWN

Millenia Psychiatry & Research, Inc, Orlando

33016

RECRUITING

Galiz Research LLC, Hialeah

33064

TERMINATED

Quantum Laboratories Inc., Pompano Beach

33125

WITHDRAWN

Central Miami Medical Institute, LLC, Miami

33135

TERMINATED

Clintex Research Group, Inc., Miami

WITHDRAWN

Research Center Of Florida, Inc, Miami

33166

WITHDRAWN

Ocean Blue Medical Research Center, Miami Springs

33319

WITHDRAWN

Segal Trials Corporate, Lauderhill

33325

TERMINATED

Sunrise Research Institute, Boca Raton

33409

TERMINATED

Psychiatric Specialty Center, West Palm Beach

33411

RECRUITING

Advanced Mental Health Care Inc., Royal Palm Beach

33431

RECRUITING

Mindful Behavioral Health, Boca Raton

33613

RECRUITING

Stedman Clinical Trials, Tampa

33770

RECRUITING

Florida Behavioral Psych, Largo

34609

TERMINATED

Medycal Research, Inc, Brooksville

35294

RECRUITING

University of Alabama at Birmingham, Birmingham

35801

RECRUITING

UAB Huntsville Regional Medical Center, Huntsville

37027

RECRUITING

Neuroscience and TMS Treatment Center, Brentwood

39216

TERMINATED

Andrew Bishop, MD, Jackson

39232

RECRUITING

Precise Research Centers, Flowood

43210

RECRUITING

The Ohio State University, Columbus

44106

WITHDRAWN

University Hospitals Case Medical Center, Cleveland

44125

RECRUITING

Charak Center for Health and Wellness, Garfield Heights

44333

RECRUITING

Signature Research Associates, Inc., Fairlawn

46601

RECRUITING

Beacon Medical Group Behavioral Health, South Bend

48105

ACTIVE_NOT_RECRUITING

Michigan Clinical Research Institute PC, Ann Arbor

53719

RECRUITING

University of Wisconsin, Madison

55416

RECRUITING

University of Minnesota, Minneapolis

56268

TERMINATED

Advanced Research Institute, Inc., Indianapolis

60076

RECRUITING

Psychiatric Medicine Associates, LLC, Skokie

60435

TERMINATED

Joliet Center For Clinical Research, Joliet

60563

RECRUITING

AMR- Baber Research, Inc., Naperville

60612

RECRUITING

Rush University Medical Center, Chicago

60910

WITHDRAWN

Neuroscience Research Institute, Winfield

62794

RECRUITING

Southern Illinois University School of Medicine, Springfield

63110

RECRUITING

Barnes-Jewish Hospital, St Louis

63128

RECRUITING

PsychCare Consultants Research, St Louis

65212

RECRUITING

University of Missouri, Columbia

66160

RECRUITING

University Of Kansas Cancer Center, Kansas City

68526

RECRUITING

Alivation Research, LLC, Lincoln

73112

TERMINATED

Rivus Wellness & Research Institute, Oklahoma City

74135

RECRUITING

University of Oklahoma School of Community Medicine, Tulsa

75057

RECRUITING

Northpointe Psychiatry, Lewisville

75390

RECRUITING

University of Texas Southwestern, Dallas

77054

RECRUITING

The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders, Houston

77401

TERMINATED

Houston Clinical Trials, Houston

77459

TERMINATED

Rise Clinical Research, LLC, Missouri City

78712

RECRUITING

UT Health Austin, Mulva Clinic for the Neurosciences, Austin

78759

TERMINATED

BioBehavioral Research of Austin, Austin

79905

RECRUITING

Texas Tech University Health Science Center, El Paso

83406

WITHDRAWN

Pearl Health Clinic, Ammon

84108

RECRUITING

The University of Utah, Salt Lake City

87102

WITHDRAWN

University of New Mexico - Psychiatric Center, Albuquerque

90033

RECRUITING

Keck Hospital of USC, Los Angeles

92037

RECRUITING

Kaizen Brain Center, La Jolla

92103

ACTIVE_NOT_RECRUITING

University of California San Diego, San Diego

92324

WITHDRAWN

CMB Clinical Trials, Colton

92626

RECRUITING

ATP Clinical Research, Inc., Costa Mesa

92705

WITHDRAWN

Syrentis Clinical Research, Santa Ana

94010

TERMINATED

Access Multi Specialty Medical Clinic, Inc, Burlingame

94901

TERMINATED

SF-CARE, Inc., San Rafael

RECRUITING

Florida Center for TMS, Saint Augustine

98040

RECRUITING

Center For Anxiety and Depression, Mercer Island

98104

RECRUITING

Seattle Neuropsychiatric Treatment Center, Seattle

633668

RECRUITING

Psychiatric Care and Research, O'Fallon

02114

RECRUITING

Massachusetts General Hospital, Boston

03060

RECRUITING

Healthy Perspective, Nashua

07753

WITHDRAWN

Jersey Shore University Medical Center, Neptune City

73109-3834

WITHDRAWN

NPC Research, Oklahoma City

05091

TERMINATED

Neuropsychiatric Associates, Plc, Woodstock

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LivaNova

INDUSTRY