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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
LivaNova
Study ID
NCT03887715
Status
Recruiting
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Conditions

  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vagus Nerve Stimulation (VNS) — DEVICE
    VNS is an implantable device that delivers stimulation to the vagal nerve.

Study Details

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.

Key Dates

Start date
Sep 26, 2019
Status verified
Jan 2026
Primary completion
Feb 28, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
6,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response [ Time Frame: 12 months post randomization ]

Central Contacts

Locations (98)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Candace Green
[email protected]
205-976-0068
Matthew Macaluso, DO (PRINCIPAL_INVESTIGATOR)
UAB Huntsville Regional Medical CenterHuntsvilleAlabama35801
Michael Howell
[email protected]
256-551-4431
Richard Shelton (PRINCIPAL_INVESTIGATOR)
Access Multi Specialty Medical Clinic, IncBurlingameCalifornia94010-
CMB Clinical TrialsColtonCalifornia92324-
ATP Clinical Research, Inc.Costa MesaCalifornia92626
Bobby Shih
[email protected]
714-277-4472
Gustavo Alva, MD (PRINCIPAL_INVESTIGATOR)
Kaizen Brain CenterLa JollaCalifornia92037
Melissa Escamirosa
[email protected]
866-277-2659
Mohammed Ahmed, MD (PRINCIPAL_INVESTIGATOR)
Keck Hospital of USCLos AngelesCalifornia90033
Zoe Durkin
[email protected]
213-631-8487
Ashraf Elmashat, MD (PRINCIPAL_INVESTIGATOR)
University of California San DiegoSan DiegoCalifornia92103-
SF-CARE, Inc.San RafaelCalifornia94901-
Syrentis Clinical ResearchSanta AnaCalifornia92705-
Mindful Behavioral HealthBoca RatonFlorida33431
Alexis Archer
[email protected]
561-499-6933
Ivan Cichowicz, MD (PRINCIPAL_INVESTIGATOR)
Sunrise Research InstituteBoca RatonFlorida33325-
Medycal Research, IncBrooksvilleFlorida34609-
Galiz Research LLCHialeahFlorida33016
Yohana Lima
[email protected]
305-805-0921
Jose Gamez, MD (PRINCIPAL_INVESTIGATOR)
Florida Behavioral PsychLargoFlorida33770
Carlos Bussey
[email protected]
727-510-9773
Ashok Patel, MD (PRINCIPAL_INVESTIGATOR)
Segal Trials CorporateLauderhillFlorida33319-
Central Miami Medical Institute, LLCMiamiFlorida33125-
Clintex Research Group, Inc.MiamiFlorida33135-
Research Center Of Florida, IncMiamiFlorida33135-
Ocean Blue Medical Research CenterMiami SpringsFlorida33166-
APG Research, LLCOrlandoFlorida32803
Kailee Kenworthy
[email protected]
407-808-1875
Morteza Nadjafi, MD (PRINCIPAL_INVESTIGATOR)
Florida Center for TMSOrlandoFlorida32806-
Millenia Psychiatry & Research, IncOrlandoFlorida32819-
Nova Psychiatry Inc.OrlandoFlorida32803
Carmen Torres
[email protected]
401-883-9303
David Medina, MD (PRINCIPAL_INVESTIGATOR)
Quantum Laboratories Inc.Pompano BeachFlorida33064-
Advanced Mental Health Care Inc.Royal Palm BeachFlorida33411
Elyssa Sisko
[email protected]
561-333-8884
Aron Tendler, MD (PRINCIPAL_INVESTIGATOR)
Florida Center for TMSSaint AugustineFlorida94901
Jason R Fritz
[email protected]
850-212-6262
Heather Luing, MD (PRINCIPAL_INVESTIGATOR)
Stedman Clinical TrialsTampaFlorida33613
Susan Fowler
[email protected]
813-971-8311
Mary L Stedman, MD (PRINCIPAL_INVESTIGATOR)
Psychiatric Specialty CenterWest Palm BeachFlorida33409-
Emory UniversityAtlantaGeorgia30322
Sinéad Quinn
[email protected]
404-727-9228
Patricio Riva Posse, MD (PRINCIPAL_INVESTIGATOR)
Medical College of Georgia, Augusta UniversityAugustaGeorgia30912
Laryssa McCloud
[email protected]
706-721-7968
Boadie Dunlop, MD (PRINCIPAL_INVESTIGATOR)
PACT Atlanta LLCDecaturGeorgia30030-
IACT HealthGraysonGeorgia30017-
Psych AtlantaMariettaGeorgia30060
Jennifer Kane
[email protected]
770-422-2846
Michael Banov, MD (PRINCIPAL_INVESTIGATOR)
Pearl Health ClinicAmmonIdaho83406-
Rush University Medical CenterChicagoIllinois60612
Linda Skaggs
[email protected]
312-942-6597
John Zajecka (PRINCIPAL_INVESTIGATOR)
Joliet Center For Clinical ResearchJolietIllinois60435-
AMR- Baber Research, Inc.NapervilleIllinois60563
Freeda Baber
[email protected]
630-272-4844
Riaz Baber, MD (PRINCIPAL_INVESTIGATOR)
Psychiatric Medicine Associates, LLCSkokieIllinois60076
Amanda White
[email protected]
847-679-8000
John Zajecka, MD (PRINCIPAL_INVESTIGATOR)
Southern Illinois University School of MedicineSpringfieldIllinois62794
Oladele Owasoyo, PhD
[email protected]
217-545-7321
Kalyan Kandra, MD (PRINCIPAL_INVESTIGATOR)
Neuroscience Research InstituteWinfieldIllinois60910-
Advanced Research Institute, Inc.IndianapolisIndiana56268-
Beacon Medical Group Behavioral HealthSouth BendIndiana46601-
University Of Kansas Cancer CenterKansas CityKansas66160
Jasli Bonilla
[email protected]
913-945-9790
Tyler Kjorvestad, MD (PRINCIPAL_INVESTIGATOR)
Sheppard Pratt Health System, Inc.BaltimoreMaryland21204
Bryce Lund
[email protected]
410-938-3126
Scott Aaronson, MD (PRINCIPAL_INVESTIGATOR)
Clinical InsightsGlen BurnieMaryland21061-
Massachusetts General HospitalBostonMassachusetts02114
Catherine Schuessler
[email protected]
617-643-7690
Cristina Cusin, MD (PRINCIPAL_INVESTIGATOR)
Michigan Clinical Research Institute PCAnn ArborMichigan48105-
University of MinnesotaMinneapolisMinnesota55416
Kayla Thoen
[email protected]
952-525-4505
Rachel Johnson
[email protected]
952-525-4505
Ziad Nahas, MD (PRINCIPAL_INVESTIGATOR)
Precise Research CentersFlowoodMississippi39232
Katherine Fickert
[email protected]
601-420-5810
Joseph Kwentus, MD (PRINCIPAL_INVESTIGATOR)
Andrew Bishop, MDJacksonMississippi39216-
University of MissouriColumbiaMissouri65212
Christopher Sinkler
[email protected]
573-882-5688
Muaid Ithman, MD (PRINCIPAL_INVESTIGATOR)
Psychiatric Care and ResearchO'FallonMissouri633668
Mary Beth Haug
[email protected]
636-244-3593
John Canale, MD (PRINCIPAL_INVESTIGATOR)
Barnes-Jewish HospitalSt LouisMissouri63110
Amanda Brouk
[email protected]
314-362-5113
Donald Bohnenkamp, MD (PRINCIPAL_INVESTIGATOR)
PsychCare Consultants ResearchSt LouisMissouri63128
Anita Broeker
[email protected]
314-849-1853
Shazia Malik, MD (PRINCIPAL_INVESTIGATOR)
Alivation Research, LLCLincolnNebraska68526
Lisa Ludwig
[email protected]
402-817-2236
Walter Duffy, MD (PRINCIPAL_INVESTIGATOR)
Healthy PerspectiveNashuaNew Hampshire03060
Nancy Gilbert, APRN
[email protected]
603-880-9880
Hisham Hafez, MD (PRINCIPAL_INVESTIGATOR)
Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
University of New Mexico - Psychiatric CenterAlbuquerqueNew Mexico87102-
Dent Neurological InstituteAmherstNew York14226
Michelle Rainka, PharmD
[email protected]
716-250-2038
Horacio Capote, MD (PRINCIPAL_INVESTIGATOR)
Erie County Medical Center/State University of New York (SUNY) at Buffalo AffiliateBuffaloNew York14215-
Trinity MedicalLewistonNew York14092
Tatiana Jimenez-Knight
[email protected]
716-862-2426
Alfred Belen, MD (PRINCIPAL_INVESTIGATOR)
Hapworth Research Inc.New YorkNew York10019
Mariah Garcia
[email protected]
212-956-2000
William Hapworth, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Esha Talati, BS
[email protected]
332-243-7053
James M Murrough, MD (PRINCIPAL_INVESTIGATOR)
Richmond Behavioral AssociatesStaten IslandNew York10312-
Stony Brook University HospitalStony BrookNew York11794-
State University Of New York Upstate Medical UniversitySyracuseNew York13210-
ManuMind Interventional PsychiatryWoodburyNew York11797
Lisa Cottone
[email protected]
516-808-0888
Lucian Manu, MD (PRINCIPAL_INVESTIGATOR)
The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC HealthCaryNorth Carolina27519-
Mindpath Care CentersRaleighNorth Carolina27606-
Wake Forest University Health ScienceWinston-SalemNorth Carolina27103-
University Hospitals Case Medical CenterClevelandOhio44106-
The Ohio State UniversityColumbusOhio43210
Anne-Marie Duchemin
[email protected]
614-293-5517
Kevin Reeves, MD (PRINCIPAL_INVESTIGATOR)
Signature Research Associates, Inc.FairlawnOhio44333-
Charak Center for Health and WellnessGarfield HeightsOhio44125
Brooke Bhattacharya, MS
[email protected]
715-209-4321
Rakesh Ranjan, MD (PRINCIPAL_INVESTIGATOR)
NPC ResearchOklahoma CityOklahoma73109-3834-
Rivus Wellness & Research InstituteOklahoma CityOklahoma73112-
University of Oklahoma School of Community MedicineTulsaOklahoma74135
Michelle Matukewicz, MHR
[email protected]
918-660-3118
Ondria Gleason, MD (PRINCIPAL_INVESTIGATOR)
Scranton Medical InstitutesMoosicPennsylvania18507
Stephanie Terranella
[email protected]
570-346-3686
Zoha Babar
[email protected]
570-346-3686
Matthew Berger, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Joanna Zheng
[email protected]
215-746-3513
Yvette Sheline, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Morgan Dancy
[email protected]
843-876-5141
Mark George, MD (PRINCIPAL_INVESTIGATOR)
Neuroscience and TMS Treatment CenterBrentwoodTennessee37027
Anna Raines Guidry
[email protected]
615-973-9243
Jonathan Becker, MD (PRINCIPAL_INVESTIGATOR)
BioBehavioral Research of AustinAustinTexas78759-
UT Health Austin, Mulva Clinic for the NeurosciencesAustinTexas78712
Tyler Wilson
[email protected]
512-495-5566
Tara Upchurch
[email protected]
512-495-5566
Julie Farrington, MD (PRINCIPAL_INVESTIGATOR)
University of Texas SouthwesternDallasTexas75390
Hila Abush Segev, PhD
[email protected]
214-648-0401
Kala Bailey, MD (PRINCIPAL_INVESTIGATOR)
Texas Tech University Health Science CenterEl PasoTexas79905
Peter Thompson (PI), MD
[email protected]
915-215-5850
Houston Clinical TrialsHoustonTexas77401-
The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood DisordersHoustonTexas77054
Marcela Carbajal Tamez
[email protected]
713-486-2567
Joao De Quevedo, MD, PhD (PRINCIPAL_INVESTIGATOR)
Northpointe PsychiatryLewisvilleTexas75057
Asad Islam (PI), MD
[email protected]
214-799-8277
Rise Clinical Research, LLCMissouri CityTexas77459-
The University of UtahSalt Lake CityUtah84108
Brian Mickey (PI), MD, PhD
801-587-3297
Sarah Kwon
[email protected]
(801) 829-7382
Neuropsychiatric Associates, PlcWoodstockVermont05091-
Carilion ClinicRoanokeVirginia24014
Maryann Hollen
[email protected]
540-527-4875
Anita Kablinger, MD (PRINCIPAL_INVESTIGATOR)
Center For Anxiety and DepressionMercer IslandWashington98040
David L Dunner (PI), MD
[email protected]
206-230-0330
Seattle Neuropsychiatric Treatment CenterSeattleWashington98104
Allison Chen
[email protected]
206-467-6300
Rebecca Allen, MD (PRINCIPAL_INVESTIGATOR)
Marshall University Joan C. Edwards School of MedicineHuntingtonWest Virginia25701
Dakota May, MD
[email protected]
304-691-1500
Dakota May, MD (PRINCIPAL_INVESTIGATOR)
West Virginia Clinical and Translational Science InstituteMorgantownWest Virginia26506-
University of WisconsinMadisonWisconsin53719
Rick Stauffacher
[email protected]
608-262-7722
Steven Garlow (PRINCIPAL_INVESTIGATOR)

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