Recruiting

VNS TherapyA 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

Sponsor:

LivaNova

Code:

NCT03887715

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vagus Nerve Stimulation (VNS)

Study Details

Brief summary:

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 ID

NCT03887715

Start date

Sep 26, 2019

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.

The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.

The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.

Patients must maintain a stable medication regimen for at least four weeks before device implantation.

Exclusion Criteria:

Current or lifetime history of psychotic features in any MDE;

Current or lifetime history of schizophrenia or schizoaffective disorder;

Current or lifetime history of any other psychotic disorder;

Current or lifetime history of rapid cycling bipolar disorder;

Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;

Current suicidal intent; or

Treatment with another investigational device or investigational drugs.

Study Design

Enrollment

6800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active

Group will have VNS activated 2 weeks post implant.

sham comparator: Control

Group will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.

Interventions

Vagus Nerve Stimulation (VNS)

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

Primary outcome measure

Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response [ Time Frame: 12 months post randomization ]
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response [ Time Frame: Baseline up to 12 Months ]
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission [ Time Frame: Baseline up to 12 Months ]
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response [ Time Frame: Baseline up to 12 Months ]
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission [ Time Frame: Baseline up to 12 Months ]
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response [ Time Frame: Baseline up to 12 Months ]
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission [ Time Frame: Baseline up to 12 Months ]
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission [ Time Frame: Baseline up to 12 Months ]
Assess all Adverse Events [ Time Frame: Implant to 12 Months ]
WHO Disability Assessment Schedule (WHODAS) Changes in scores over time [ Time Frame: Baseline to 12 Months ]
Health Outcome Scale (EQ-5D-L) Changes in scores over time [ Time Frame: Baseline to 12 Months ]
Clinical Global Impressions Scale - Improvement (CGI-I) Response [ Time Frame: 12 months post randomization ]
Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality [ Time Frame: Implant to 12 Months ]

Central Contacts and Locations

Central contacts

Laura Yates, BSN

281-228-7200 laura.yates@livanova.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Candace Green

205-976-0068 candacegreen@uabmc.edu

Principal Investigator:

Matthew Macaluso, DO

UAB Huntsville Regional Medical Center

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Michael Howell

256-551-4431 hsvpsychresearch@uabmc.edu

Principal Investigator:

Richard Shelton

ATP Clinical Research, Inc.

Recruiting

Costa Mesa, California, United States, 92626

Contacts

Bobby Shih

714-277-4472 bshih@atpcr.com

Principal Investigator:

Gustavo Alva, MD

Kaizen Brain Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Melissa Escamirosa

866-277-2659 melissa@kaizenbraincenter.com

Principal Investigator:

Mohammed Ahmed, MD

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Zoe Durkin

213-631-8487 zoe.durkin@med.usc.edu

Principal Investigator:

Ashraf Elmashat, MD

Mindful Behavioral Health

Recruiting

Boca Raton, Florida, United States, 33431

Contacts

Alexis Archer

561-499-6933 alexismarie@kindresearchgroup.com

Principal Investigator:

Ivan Cichowicz, MD

Galiz Research LLC

Recruiting

Hialeah, Florida, United States, 33016

Contacts

Yohana Lima

305-805-0921 yohana@galizresearch.com

Principal Investigator:

Jose Gamez, MD

Flourish Research - St. Augustine

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Comelia Partin, RN

904-209-0043 cpartin@flourishresearch.com

Principal Investigator:

Heather Luing

Florida Behavioral Psych

Recruiting

Largo, Florida, United States, 33770

Contacts

Carlos Bussey

727-510-9773 cbussey@vantagetrials.com

Principal Investigator:

Ashok Patel, MD

APG Research, LLC

Recruiting

Orlando, Florida, United States, 32803

Contacts

Kailee Kenworthy

407-808-1875 kkenworthyapg@gmail.com

Principal Investigator:

Morteza Nadjafi, MD

Nova Psychiatry Inc.

Recruiting

Orlando, Florida, United States, 32803

Contacts

Carmen Torres

401-883-9303 novapsychiatryinc@gmail.com

Principal Investigator:

David Medina, MD

IPTB Clinical Research

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jamie Winderbaum Fernandez

813-251-1800

Principal Investigator:

Jamie Winderbaum Fernandez

K2 Medical Research

Recruiting

Tampa, Florida, United States, 33634

Contacts

Kaitlyn Turner

813-800-5252 Kaitlyn.Turner@k2med.com

Principal Investigator:

Kelley Wilson, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sinéad Quinn

404-727-9228 scquinn@emory.edu

Principal Investigator:

Patricio Riva Posse, MD

Medical College of Georgia, Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Laryssa McCloud

706-721-7968 lmccloud@augusta.edu

Principal Investigator:

Boadie Dunlop, MD

Psych Atlanta

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Jennifer Kane

770-422-2846 jenniferk@nbmedicine.com

Principal Investigator:

Michael Banov, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Linda Skaggs

312-942-6597 linda_skaggs@rush.edu

Principal Investigator:

John Zajecka

AMR- Baber Research, Inc.

Recruiting

Naperville, Illinois, United States, 60563

Contacts

Freeda Baber

630-272-4844 freeda@baberresearchgroup.com

Principal Investigator:

Riaz Baber, MD

Psychiatric Medicine Associates, LLC

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Amanda White

847-679-8000 awhite.pma@gmail.com

Principal Investigator:

John Zajecka, MD

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62794

Contacts

Oladele Owasoyo, PhD

217-545-7321 Oowasoyo94@siumed.edu

Principal Investigator:

Kalyan Kandra, MD

University Of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jasli Bonilla

913-945-9790 jbonilla@kumc.edu

Principal Investigator:

Tyler Kjorvestad, MD

Sheppard Pratt Health System, Inc.

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Bryce Lund

410-938-3126 Bryce.lund1@sheppardpratt.org

Principal Investigator:

Scott Aaronson, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Catherine Schuessler

617-643-7690 cschuessler@mgh.harvard.edu

Principal Investigator:

Cristina Cusin, MD

Michigan Clinical Research Institute PC

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Mohammad Al-Matarneh

734-834-8954 matarneh@earlytreatment.org

Principal Investigator:

Ravi Kirbat

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55416

Contacts

Kayla Thoen

952-525-4505 ipl@umn.edu

Rachel Johnson

952-525-4505 ipl@umn.edu

Principal Investigator:

Ziad Nahas, MD

Precise Research Centers

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

Katherine Fickert

601-420-5810 kfickert@precise-research.com

Principal Investigator:

Joseph Kwentus, MD

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Christopher Sinkler

573-882-5688 sinklercs@health.missouri.edu

Principal Investigator:

Muaid Ithman, MD

Psychiatric Care and Research

Recruiting

O'Fallon, Missouri, United States, 633668

Contacts

Mary Beth Haug

636-244-3593 mhaug@pcrc-stl.com

Principal Investigator:

John Canale, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Amanda Brouk

314-362-5113 abrouk@wustl.edu

Principal Investigator:

Donald Bohnenkamp, MD

Alivation Research, LLC

Recruiting

Lincoln, Nebraska, United States, 68526

Contacts

Lisa Ludwig

402-817-2236 lludwig@alivation.com

Principal Investigator:

Walter Duffy, MD

Healthy Perspective

Recruiting

Nashua, New Hampshire, United States, 03060

Contacts

Nancy Gilbert, APRN

603-880-9880 ngilbert@hp-imhs.com

Principal Investigator:

Hisham Hafez, MD

Dent Neurological Institute

Recruiting

Amherst, New York, United States, 14226

Contacts

Michelle Rainka, PharmD

716-250-2038 mrainka@dentinstitute.com

Principal Investigator:

Horacio Capote, MD

Trinity Medical

Recruiting

Lewiston, New York, United States, 14092

Contacts

Tatiana Jimenez-Knight

716-862-2426 tjimenezknight@chsbuffalo.org

Principal Investigator:

Alfred Belen, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Esha Talati, BS

332-243-7053 esha.talati@mssm.edu

Principal Investigator:

James M Murrough, MD

ManuMind Interventional Psychiatry

Recruiting

Woodbury, New York, United States, 11797

Contacts

Lisa Cottone

516-808-0888 lisa.cottone@manumind.com

Principal Investigator:

Lucian Manu, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Anne-Marie Duchemin

614-293-5517 anne-marie.duchemin@osumc.edu

Principal Investigator:

Kevin Reeves, MD

Charak Center for Health and Wellness

Recruiting

Garfield Heights, Ohio, United States, 44125

Contacts

Brooke Bhattacharya, MS

715-209-4321 bbhattacharya@charakcenter.com

Principal Investigator:

Rakesh Ranjan, MD

University of Oklahoma School of Community Medicine

Recruiting

Tulsa, Oklahoma, United States, 74135

Contacts

Michelle Matukewicz, MHR

918-660-3118 Michelle-matukewicz@ouhsc.edu

Principal Investigator:

Ondria Gleason, MD

Scranton Medical Institutes

Recruiting

Moosic, Pennsylvania, United States, 18507

Contacts

Stephanie Terranella

570-346-3686 sterranella@gminstitutes.com

Zoha Babar

570-346-3686 zbabar@gminstitutes.com

Principal Investigator:

Matthew Berger, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Joanna Zheng

215-746-3513 Joanna.Zheng@Pennmedicine.upenn.edu

Principal Investigator:

Yvette Sheline, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Morgan Dancy

843-876-5141 maddoxm@musc.edu

Principal Investigator:

Mark George, MD

Neuroscience and TMS Treatment Center

Recruiting

Brentwood, Tennessee, United States, 37027

Contacts

Anna Raines Guidry

615-973-9243 anna.guidry@hopeforyourbrain.com

Principal Investigator:

Jonathan Becker, MD

UT Health Austin, Mulva Clinic for the Neurosciences

Recruiting

Austin, Texas, United States, 78712

Contacts

Tyler Wilson

512-495-5566 tyler.wilson@austin.utexas.edu

Tara Upchurch

512-495-5566 tara.upchurch@austin.utexas.edu

Principal Investigator:

Julie Farrington, MD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Hila Abush Segev, PhD

214-648-0401 Hila.abushsegev@utsouthwestern.edu

Principal Investigator:

Kala Bailey, MD

Texas Tech University Health Science Center

Recruiting

El Paso, Texas, United States, 79905

Contacts

Peter Thompson (PI), MD

915-215-5850 pm.thompson@ttuhsc.edu

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

Recruiting

Houston, Texas, United States, 77054

Contacts

Marcela Carbajal Tamez

713-486-2567 cip.research@uth.tmc.edu

Principal Investigator:

Joao De Quevedo, MD, PhD

Northpointe Psychiatry

Recruiting

Lewisville, Texas, United States, 75057

Contacts

Asad Islam (PI), MD

214-799-8277 northpointe.research@gmail.com

The University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Brian Mickey (PI), MD, PhD

801-587-3297

Sarah Kwon

(801) 829-7382 sarah.kwon@hsc.utah.edu

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Maryann Hollen

540-527-4875 mhollen@carilionclinic.org

Principal Investigator:

Anita Kablinger, MD

Center For Anxiety and Depression

Recruiting

Mercer Island, Washington, United States, 98040

Contacts

David L Dunner (PI), MD

206-230-0330 dldunner@comcast.net

Seattle Neuropsychiatric Treatment Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Allison Chen

206-467-6300 recovervns@seattlentc.com

Principal Investigator:

Rebecca Allen, MD

Marshall University Joan C. Edwards School of Medicine

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Dakota May, MD

304-691-1500 May110@marshall.edu

Principal Investigator:

Dakota May, MD

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53719

Contacts

Rick Stauffacher

608-262-7722 rstauffach@clinicaltrials.wisc.edu

Principal Investigator:

Steven Garlow

More Information

Sponsor

LivaNova

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

VNS
Depression
TRD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by LivaNova on 2026-06-15.