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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

LivaNova · NCT03887715

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
6800
US sites recruiting
50
Study start
September 26, 2019
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Vagus Nerve Stimulation (VNS)

Conditions: Treatment Resistant Depression

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35294

    Site contact: Candace Green · 205-976-0068 · candacegreen@uabmc.edu

  • UAB Huntsville Regional Medical Center

    Huntsville, AL 35801

    Site contact: Michael Howell · 256-551-4431 · hsvpsychresearch@uabmc.edu

  • ATP Clinical Research, Inc.

    Costa Mesa, CA 92626

    Site contact: Bobby Shih · 714-277-4472 · bshih@atpcr.com

  • Salma Health

    La Jolla, CA 92037

    Site contact: Melissa Escamirosa · 866-277-2659 · melissa@kaizenbraincenter.com

  • Keck Hospital of USC

    Los Angeles, CA 90033

    Site contact: Zoe Durkin · 213-631-8487 · zoe.durkin@med.usc.edu

  • Mindful Behavioral Health

    Boca Raton, FL 33431

    Site contact: Alexis Archer · 561-499-6933 · alexismarie@kindresearchgroup.com

  • Galiz Research LLC

    Hialeah, FL 33016

    Site contact: Yohana Lima · 305-805-0921 · yohana@galizresearch.com

  • Flourish Research - St. Augustine

    Jacksonville, FL 32216

    Site contact: Comelia Partin, RN · 904-209-0043 · cpartin@flourishresearch.com

  • APG Research, LLC

    Orlando, FL 32803

    Site contact: Kailee Kenworthy · 407-808-1875 · kkenworthyapg@gmail.com

  • Nova Psychiatry Inc.

    Orlando, FL 32803

    Site contact: Carmen Torres · 401-883-9303 · novapsychiatryinc@gmail.com

  • IPTB Clinical Research

    Tampa, FL 33612

    Site contact: Jamie Winderbaum Fernandez · 813-251-1800

  • K2 Medical Research

    Tampa, FL 33634

    Site contact: Kaitlyn Turner · 813-800-5252 · Kaitlyn.Turner@k2med.com

  • Emory University

    Atlanta, GA 30322

    Site contact: Sinéad Quinn · 404-727-9228 · scquinn@emory.edu

  • Medical College of Georgia, Augusta University

    Augusta, GA 30912

    Site contact: Laryssa McCloud · 706-721-7968 · lmccloud@augusta.edu

  • Psych Atlanta

    Marietta, GA 30060

    Site contact: Jennifer Kane · 770-422-2846 · jenniferk@nbmedicine.com

  • Rush University Medical Center

    Chicago, IL 60612

    Site contact: Linda Skaggs · 312-942-6597 · linda_skaggs@rush.edu

  • AMR- Baber Research, Inc.

    Naperville, IL 60563

    Site contact: Freeda Baber · 630-272-4844 · freeda@baberresearchgroup.com

  • Psychiatric Medicine Associates, LLC

    Skokie, IL 60076

    Site contact: Amanda White · 847-679-8000 · awhite.pma@gmail.com

  • Southern Illinois University School of Medicine

    Springfield, IL 62794

    Site contact: Oladele Owasoyo, PhD · 217-545-7321 · Oowasoyo94@siumed.edu

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Jasli Bonilla · 913-945-9790 · jbonilla@kumc.edu

  • Sheppard Pratt Health System, Inc.

    Baltimore, MD 21204

    Site contact: Bryce Lund · 410-938-3126 · Bryce.lund1@sheppardpratt.org

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Catherine Schuessler · 617-643-7690 · cschuessler@mgh.harvard.edu

  • Michigan Clinical Research Institute PC

    Ann Arbor, MI 48105

    Site contact: Mohammad Al-Matarneh · 734-834-8954 · matarneh@earlytreatment.org

  • University of Minnesota

    Minneapolis, MN 55416

    Site contact: Kayla Thoen · 952-525-4505 · ipl@umn.edu

  • Precise Research Centers

    Flowood, MS 39232

    Site contact: Katherine Fickert · 601-420-5810 · kfickert@precise-research.com

  • University of Missouri

    Columbia, MO 65212

    Site contact: Christopher Sinkler · 573-882-5688 · sinklercs@health.missouri.edu

  • Psychiatric Care and Research

    O'Fallon, MO 633668

    Site contact: Mary Beth Haug · 636-244-3593 · mhaug@pcrc-stl.com

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: Amanda Brouk · 314-362-5113 · abrouk@wustl.edu

  • Alivation Research, LLC

    Lincoln, NE 68526

    Site contact: Lisa Ludwig · 402-817-2236 · lludwig@alivation.com

  • Healthy Perspective

    Nashua, NH 03060

    Site contact: Nancy Gilbert, APRN · 603-880-9880 · ngilbert@hp-imhs.com

  • Dent Neurological Institute

    Amherst, NY 14226

    Site contact: Michelle Rainka, PharmD · 716-250-2038 · mrainka@dentinstitute.com

  • Trinity Medical

    Lewiston, NY 14092

    Site contact: Tatiana Jimenez-Knight · 716-862-2426 · tjimenezknight@chsbuffalo.org

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: Esha Talati, BS · 332-243-7053 · esha.talati@mssm.edu

  • ManuMind Interventional Psychiatry

    Woodbury, NY 11797

    Site contact: Lisa Cottone · 516-808-0888 · lisa.cottone@manumind.com

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Anne-Marie Duchemin · 614-293-5517 · anne-marie.duchemin@osumc.edu

  • Signature Research Associates, Inc.

    Fairlawn, OH 44333

    Site contact: Carl Faust · 330-835-4000 · faust.carl@yahoo.com

  • Charak Center for Health and Wellness

    Garfield Heights, OH 44125

    Site contact: Brooke Bhattacharya, MS · 715-209-4321 · bbhattacharya@charakcenter.com

  • Scranton Medical Institutes

    Moosic, PA 18507

    Site contact: Stephanie Terranella · 570-346-3686 · sterranella@gminstitutes.com

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Morgan Dancy · 843-876-5141 · maddoxm@musc.edu

  • Neuroscience and TMS Treatment Center

    Brentwood, TN 37027

    Site contact: Anna Raines Guidry · 615-973-9243 · anna.guidry@hopeforyourbrain.com

  • UT Health Austin, Mulva Clinic for the Neurosciences

    Austin, TX 78712

    Site contact: Tyler Wilson · 512-495-5566 · tyler.wilson@austin.utexas.edu

  • University of Texas Southwestern

    Dallas, TX 75390

    Site contact: Hila Abush Segev, PhD · 214-648-0401 · Hila.abushsegev@utsouthwestern.edu

  • Texas Tech University Health Science Center

    El Paso, TX 79905

    Site contact: 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

    Houston, TX 77054

    Site contact: Marcela Carbajal Tamez · 713-486-2567 · cip.research@uth.tmc.edu

  • The University of Utah

    Salt Lake City, UT 84108

    Site contact: Brian Mickey (PI), MD, PhD · 801-587-3297

  • Carilion Clinic

    Roanoke, VA 24014

    Site contact: Maryann Hollen · 540-527-4875 · mhollen@carilionclinic.org

  • Center For Anxiety and Depression

    Mercer Island, WA 98040

    Site contact: Christina Demopulos, MD · 206-230-0330 · cmdmd999@gmail.com

  • Seattle Neuropsychiatric Treatment Center

    Seattle, WA 98104

    Site contact: Allison Chen · 206-467-6300 · recovervns@seattlentc.com

  • Marshall University Joan C. Edwards School of Medicine

    Huntington, WV 25701

    Site contact: Dakota May, MD · 304-691-1500 · May110@marshall.edu

  • University of Wisconsin

    Madison, WI 53719

    Site contact: Rick Stauffacher · 608-262-7722 · rstauffach@clinicaltrials.wisc.edu

Study contacts (from the official record)

  • Laura Yates, BSN · 281-228-7200 · laura.yates@livanova.com
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A Prospective, Multi-center, Randomized Controlled Blinded Trial… (NCT03887715) | Bored Studies