AzTrials
AzTrials

Treatment Resistant DepressionRECOVERNCT03887715

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

A study testing Vagus Nerve Stimulation (VNS) in people with Treatment Resistant Depression, run by LivaNova at 101 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Treatment Resistant Depression
What is being tested?
Vagus Nerve Stimulation (VNS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,800 participants
Where
101 sitesUnited States
Study dates
26 Sep 2019to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

101 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Yates, BSN contact

281-228-7200

laura.yates@livanova.com

101 sites in 1 country

United States101 sites, 50 recruiting

  • University of New Mexico - Psychiatric Center

    Albuquerque, New Mexico, 87102

    Withdrawn

  • Dent Neurological Institute

    Amherst, New York, 14226

    Michelle Rainka, PharmD, 716-250-2038, mrainka@dentinstitute.com

    Horacio Capote, MD

    Recruiting

  • Pearl Health Clinic

    Ammon, Idaho, 83406

    Withdrawn

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan, 48105

    Mohammad Al-Matarneh, 734-834-8954, matarneh@earlytreatment.org

    Ravi Kirbat

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Sinéad Quinn, 404-727-9228, scquinn@emory.edu

    Patricio Riva Posse, MD

    Recruiting

  • Medical College of Georgia, Augusta University

    Augusta, Georgia, 30912

    Laryssa McCloud, 706-721-7968, lmccloud@augusta.edu

    Boadie Dunlop, MD

    Recruiting

  • UT Health Austin, Mulva Clinic for the Neurosciences

    Austin, Texas, 78712

    Tyler Wilson, 512-495-5566, tyler.wilson@austin.utexas.edu

    Tara Upchurch, 512-495-5566, tara.upchurch@austin.utexas.edu

    Recruiting

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

    Terminated

  • Sheppard Pratt Health System, Inc.

    Baltimore, Maryland, 21204

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

    Scott Aaronson, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Candace Green, 205-976-0068, candacegreen@uabmc.edu

    Matthew Macaluso, DO

    Recruiting

  • Sunrise Research Institute

    Boca Raton, Florida, 33325

    Terminated

  • Mindful Behavioral Health

    Boca Raton, Florida, 33431

    Alexis Archer, 561-499-6933, alexismarie@kindresearchgroup.com

    Ivan Cichowicz, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Catherine Schuessler, 617-643-7690, cschuessler@mgh.harvard.edu

    Cristina Cusin, MD

    Recruiting

  • Neuroscience and TMS Treatment Center

    Brentwood, Tennessee, 37027

    Anna Raines Guidry, 615-973-9243, anna.guidry@hopeforyourbrain.com

    Jonathan Becker, MD

    Recruiting

  • Medycal Research, Inc

    Brooksville, Florida, 34609

    Terminated

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

    Buffalo, New York, 14215

    Withdrawn

  • Access Multi Specialty Medical Clinic, Inc

    Burlingame, California, 94010

    Terminated

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

    Cary, North Carolina, 27519

    Terminated

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Morgan Dancy, 843-876-5141, maddoxm@musc.edu

    Mark George, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Linda Skaggs, 312-942-6597, linda_skaggs@rush.edu

    John Zajecka

    Recruiting

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

    Withdrawn

  • CMB Clinical Trials

    Colton, California, 92324

    Withdrawn

  • University of Missouri

    Columbia, Missouri, 65212

    Christopher Sinkler, 573-882-5688, sinklercs@health.missouri.edu

    Muaid Ithman, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Anne-Marie Duchemin, 614-293-5517, anne-marie.duchemin@osumc.edu

    Kevin Reeves, MD

    Recruiting

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

    Bobby Shih, 714-277-4472, bshih@atpcr.com

    Gustavo Alva, MD

    Recruiting

  • University of Texas Southwestern

    Dallas, Texas, 75390

    Hila Abush Segev, PhD, 214-648-0401, Hila.abushsegev@utsouthwestern.edu

    Kala Bailey, MD

    Recruiting

  • PACT Atlanta LLC

    Decatur, Georgia, 30030

    Terminated

  • Texas Tech University Health Science Center

    El Paso, Texas, 79905

    Peter Thompson (PI), MD, 915-215-5850, pm.thompson@ttuhsc.edu

    Recruiting

  • Signature Research Associates, Inc.

    Fairlawn, Ohio, 44333

    Carl Faust, 330-835-4000, faust.carl@yahoo.com

    Anand Chaturvedi

    Recruiting

  • Precise Research Centers

    Flowood, Mississippi, 39232

    Katherine Fickert, 601-420-5810, kfickert@precise-research.com

    Joseph Kwentus, MD

    Recruiting

  • Charak Center for Health and Wellness

    Garfield Heights, Ohio, 44125

    Brooke Bhattacharya, MS, 715-209-4321, bbhattacharya@charakcenter.com

    Rakesh Ranjan, MD

    Recruiting

  • Clinical Insights

    Glen Burnie, Maryland, 21061

    Withdrawn

  • IACT Health

    Grayson, Georgia, 30017

    Withdrawn

  • Galiz Research LLC

    Hialeah, Florida, 33016

    Yohana Lima, 305-805-0921, yohana@galizresearch.com

    Jose Gamez, MD

    Recruiting

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

    Houston, Texas, 77054

    Marcela Carbajal Tamez, 713-486-2567, cip.research@uth.tmc.edu

    Joao De Quevedo, MD, PhD

    Recruiting

  • Houston Clinical Trials

    Houston, Texas, 77401

    Terminated

  • Marshall University Joan C. Edwards School of Medicine

    Huntington, West Virginia, 25701

    Dakota May, MD, 304-691-1500, May110@marshall.edu

    Dakota May, MD

    Recruiting

  • UAB Huntsville Regional Medical Center

    Huntsville, Alabama, 35801

    Michael Howell, 256-551-4431, hsvpsychresearch@uabmc.edu

    Clinton Martin, MD

    Recruiting

  • Advanced Research Institute, Inc.

    Indianapolis, Indiana, 56268

    Terminated

  • Andrew Bishop, MD

    Jackson, Mississippi, 39216

    Terminated

  • Flourish Research - St. Augustine

    Jacksonville, Florida, 32216

    Comelia Partin, RN, 904-209-0043, cpartin@flourishresearch.com

    Heather Luing

    Recruiting

  • Joliet Center For Clinical Research

    Joliet, Illinois, 60435

    Terminated

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Jasli Bonilla, 913-945-9790, jbonilla@kumc.edu

    Tyler Kjorvestad, MD

    Recruiting

  • Salma Health

    La Jolla, California, 92037

    Melissa Escamirosa, 866-277-2659, melissa@kaizenbraincenter.com

    Mohammed Ahmed, MD

    Recruiting

  • Florida Behavioral Medicine

    Largo, Florida, 33770

    Terminated

  • Segal Trials Corporate

    Lauderhill, Florida, 33319

    Withdrawn

  • Trinity Medical

    Lewiston, New York, 14092

    Tatiana Jimenez-Knight, 716-862-2426, tjimenezknight@chsbuffalo.org

    Alfred Belen, MD

    Recruiting

  • Northpointe Psychiatry

    Lewisville, Texas, 75057

    Terminated

  • Alivation Research, LLC

    Lincoln, Nebraska, 68526

    Lisa Ludwig, 402-817-2236, lludwig@alivation.com

    Walter Duffy, MD

    Recruiting

  • Keck Hospital of USC

    Los Angeles, California, 90033

    Zoe Durkin, 213-631-8487, zoe.durkin@med.usc.edu

    Ashraf Elmashat, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53719

    Rick Stauffacher, 608-262-7722, rstauffach@clinicaltrials.wisc.edu

    Steven Garlow

    Recruiting

  • Psych Atlanta

    Marietta, Georgia, 30060

    Jennifer Kane, 770-422-2846, jenniferk@nbmedicine.com

    Michael Banov, MD

    Recruiting

  • Center For Anxiety and Depression

    Mercer Island, Washington, 98040

    Christina Demopulos, MD, 206-230-0330, cmdmd999@gmail.com

    Christina Demopulos, MD

    Recruiting

  • Central Miami Medical Institute, LLC

    Miami, Florida, 33125

    Withdrawn

  • Clintex Research Group, Inc.

    Miami, Florida, 33135

    Terminated

  • Research Center Of Florida, Inc

    Miami, Florida, 33135

    Withdrawn

  • Ocean Blue Medical Research Center

    Miami Springs, Florida, 33166

    Withdrawn

  • University of Minnesota

    Minneapolis, Minnesota, 55416

    Kayla Thoen, 952-525-4505, ipl@umn.edu

    Rachel Johnson, 952-525-4505, ipl@umn.edu

    Recruiting

  • Rise Clinical Research, LLC

    Missouri City, Texas, 77459

    Terminated

  • Scranton Medical Institutes

    Moosic, Pennsylvania, 18507

    Stephanie Terranella, 570-346-3686 ext. 172, sterranella@gminstitutes.com

    Zoha Babar, 570-346-3686 ext. 311, zbabar@gminstitutes.com

    Recruiting

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia, 26506

    Withdrawn

  • AMR- Baber Research, Inc.

    Naperville, Illinois, 60563

    Freeda Baber, 630-272-4844, freeda@baberresearchgroup.com

    Riaz Baber, MD

    Recruiting

  • Healthy Perspective

    Nashua, New Hampshire, 03060

    Nancy Gilbert, APRN, 603-880-9880, ngilbert@hp-imhs.com

    Hisham Hafez, MD

    Recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Withdrawn

  • Hapworth Research Inc.

    New York, New York, 10019

    Terminated

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Esha Talati, BS, 332-243-7053, esha.talati@mssm.edu

    James M Murrough, MD

    Recruiting

  • Psychiatric Care and Research

    O'Fallon, Missouri, 633668

    Mary Beth Haug, 636-244-3593, mhaug@pcrc-stl.com

    John Canale, MD

    Recruiting

  • NPC Research

    Oklahoma City, Oklahoma, 73109-3834

    Withdrawn

  • Rivus Wellness & Research Institute

    Oklahoma City, Oklahoma, 73112

    Terminated

  • APG Research, LLC

    Orlando, Florida, 32803

    Kailee Kenworthy, 407-808-1875, kkenworthyapg@gmail.com

    Morteza Nadjafi, MD

    Recruiting

  • Nova Psychiatry Inc.

    Orlando, Florida, 32803

    Carmen Torres, 401-883-9303, novapsychiatryinc@gmail.com

    David Medina, MD

    Recruiting

  • Florida Center for TMS

    Orlando, Florida, 32806

    Terminated

  • Millenia Psychiatry & Research, Inc

    Orlando, Florida, 32819

    Withdrawn

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Active, not recruiting

  • Quantum Laboratories Inc.

    Pompano Beach, Florida, 33064

    Terminated

  • Mindpath Care Centers

    Raleigh, North Carolina, 27606

    Terminated

  • Carilion Clinic

    Roanoke, Virginia, 24014

    Maryann Hollen, 540-527-4875, mhollen@carilionclinic.org

    Anita Kablinger, MD

    Recruiting

  • dTMS Center, LCC

    Royal Palm Beach, Florida, 33411

    Terminated

  • Florida Center for TMS

    Saint Augustine, Florida, 32086

    Terminated

  • The University of Utah

    Salt Lake City, Utah, 84108

    Brian Mickey (PI), MD, PhD, 801-587-3297

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

    Recruiting

  • University of California San Diego

    San Diego, California, 92103

    Active, not recruiting

  • SF-CARE, Inc.

    San Rafael, California, 94901

    Terminated

  • Syrentis Clinical Research

    Santa Ana, California, 92705

    Terminated

  • Seattle Neuropsychiatric Treatment Center

    Seattle, Washington, 98104

    Allison Chen, 206-467-6300, recovervns@seattlentc.com

    Rebecca Allen, MD

    Recruiting

  • Psychiatric Medicine Associates, LLC

    Skokie, Illinois, 60076

    Amanda White, 847-679-8000 ext. 12, awhite.pma@gmail.com

    John Zajecka, MD

    Recruiting

  • Beacon Medical Group Behavioral Health

    South Bend, Indiana, 46601

    Active, not recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794

    Oladele Owasoyo, PhD, 217-545-7321, Oowasoyo94@siumed.edu

    Kalyan Kandra, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Amanda Brouk, 314-362-5113, abrouk@wustl.edu

    Donald Bohnenkamp, MD

    Recruiting

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

    Terminated

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

    Withdrawn

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Terminated

  • State University Of New York Upstate Medical University

    Syracuse, New York, 13210

    Terminated

  • IPTB Clinical Research

    Tampa, Florida, 33612

    Jamie Winderbaum Fernandez, 813-251-1800

    Jamie Winderbaum Fernandez

    Recruiting

  • Stedman Clinical Trials

    Tampa, Florida, 33613

    Terminated

  • K2 Medical Research

    Tampa, Florida, 33634

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

    Kelley Wilson, MD

    Recruiting

  • University of Oklahoma School of Community Medicine

    Tulsa, Oklahoma, 74135

    Active, not recruiting

  • Psychiatric Specialty Center

    West Palm Beach, Florida, 33409

    Terminated

  • Neuroscience Research Institute

    Winfield, Illinois, 60910

    Withdrawn

  • Wake Forest University Health Science

    Winston-Salem, North Carolina, 27103

    Withdrawn

  • ManuMind Interventional Psychiatry

    Woodbury, New York, 11797

    Lisa Cottone, 516-808-0888 ext. 2, lisa.cottone@manumind.com

    Lucian Manu, MD

    Recruiting

  • Neuropsychiatric Associates, Plc

    Woodstock, Vermont, 05091

    Terminated

Other trials in United States

About this study

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.

Read the detailed description

A prospective, multi-center, randomized, controlled, blinded trial of subjects implanted with VNS Therapy. Active treatment and no stimulation control are randomized, at least two weeks after implantation and observed for 12-months.

After completing the 12 month endpoint in the RCT portion of the study, all RECOVER subjects will transition into the prospective, open-label, longitudinal portion of the study. Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint.

After completion of enrollment in the RCT portion or meeting of interim success criterion (whichever comes first), up to 5,800 new subjects may enroll directly into the open-label,prospective, longitudinal study. These subjects will participate in the study for approximately 5 years.

The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development (CED) decision entitled "Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2).

Being tested
Vagus Nerve Stimulation (VNS)
Keywords
VNS, Depression, TRD
Medical subject headings
Depressive Disorder, Treatment-Resistant, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vagus Nerve Stimulation (VNS)Device

    Also called VNS

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

Study groups in NCT03887715
Study groupRoleWhat they receive
ActiveActive comparatorGroup will have VNS activated 2 weeks post implant.
Receives: Device: Vagus Nerve Stimulation (VNS)
ControlSham comparatorGroup will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Receives: Device: Vagus Nerve Stimulation (VNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response

    The rate of response defined as person months of response/total months of study participation where response is at least a 50% reduction from baseline in MADRS total score. Subjects discontinuing the study before the endpoint assessment will be considered as non-responders for each successive month after discontinuance.

    Measured: 12 months post randomization

  2. Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response

    Time from randomization to the first observed MADRS response.

    Measured: Baseline up to 12 Months

  3. Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission

    Time from randomization to the first observed MADRS remission.

    Measured: Baseline up to 12 Months

  4. Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response

    Duration of MADRS response, defined as the number of consecutive months from first observed MADRS response to the first assessment of MADRS response relapse.

    Measured: Baseline up to 12 Months

  5. Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission

    The rate of remission is defined as total number of months in remission divided by total months of expected study participation. Subjects discontinuing the study before the endpoint assessment will be considered as non-in-remission for each successive month after discontinuance

    Measured: Baseline up to 12 Months

  6. Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response

    Maximum duration of MADRS response, defined as the maximum number of consecutive months in response (only for subjects experiencing MADRS response).

    Measured: Baseline up to 12 Months

  7. Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission

    Duration of MADRS remission, defined as the number of consecutive months from first observed MADRS remission to the first assessment of MADRS remission relapse (defined score > 20).

    Measured: Baseline up to 12 Months

  8. Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission

    Maximum duration of MADRS remission, defined as the maximum number of consecutive months in remission (only for subjects experiencing MADRS remission).

    Measured: Baseline up to 12 Months

  9. Assess all Adverse Events

    All adverse events, with a focus on device or procedure-related serious adverse events.

    Measured: Implant to 12 Months

  10. WHO Disability Assessment Schedule (WHODAS) Changes in scores over time

    Measured: Baseline to 12 Months

  11. Health Outcome Scale (EQ-5D-L) Changes in scores over time

    Measured: Baseline to 12 Months

  12. Clinical Global Impressions Scale - Improvement (CGI-I) Response

    A CGI-I score ≤ 2 at 12 months from randomization. Subjects discontinuing the study before the 12 months assessment will be considered as not in response for each successive month after discontinuance.

    Measured: 12 months post randomization

  13. Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality

    Suicide attempts as measured by items #10 \& #12 in S-STS scale

    Measured: Implant to 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start26 Sep 2019
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization of active stimulation vs. no stimulation for 12 months post randomization.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887715
Sponsor's protocol ID
LND-300
Acronym
RECOVER
Status last verified
Oct 2026
First submitted
21 Mar 2019
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hristidis VC, De Leon V, Van Der Vaart AD, Sackeim HA, Rush AJ, Aaronson ST, Bunker MT, Allen RM, Sheline Y, Nahas Z, Dunner DL, Gott BM, Lee YC, Gordon C, Tran Q, Shy O, Quevedo J, Riva-Posse P, Zajecka J, Mickey BJ, Duffy W, Kriedt CL, Oquendo MA, Conway CR. Impact of Vagus Nerve Stimulation on Suicidal Ideation in Markedly Treatment-Resistant Major Depression: A RECOVER Study Report. J Clin Psychiatry. 2026 Jul 8;87(3):25m16296. doi: 10.4088/JCP.25m16296.

    PubMed 42447264

  • Conway CR, Rush AJ, Aaronson ST, Bunker MT, Gordon C, George MS, Riva-Posse P, Allen RM, Nahas Z, Kriedt CL, Zajecka J, Dunner DL, Quevedo J, Sheline Y, Duffy W, Mickey BJ, Stedman M, Alva G, Manu L, Tran Q, Zorumski CF, Macaluso M, Banov M, Cusin C, Bennett JI, Brown H, Way J, Shy O, Lee YL, McAllister-Williams RH, McIntyre RS, Sackeim HA. Durability of the benefit of vagus nerve stimulation in markedly treatment-resistant major depression: a RECOVER trial report. Int J Neuropsychopharmacol. 2026 Jan 6;29(1):pyaf080. doi: 10.1093/ijnp/pyaf080.

    PubMed 41529263

  • Aaronson ST, Conway CR, Gordon C, Lee YL, George MS, Zajecka J, Riva-Posse P, Dunner DL, Macaluso M, Rosenquist PB, Mickey BJ, Sheline YI, Hristidis VC, Brown H, Kriedt CL, Tran Q, Bunker MT, Sackeim HA, Rush AJ. Prognostic and Prescriptive Predictors of Treatment Response to Adjunctive VNS Therapy in Major Depressive Disorder: A RECOVER Trial Report. J Clin Psychiatry. 2025 Jul 14;86(3):25m15850. doi: 10.4088/JCP.25m15850.

    PubMed 40673907

  • de Leon VC, Allen RM, Quevedo J, Riva-Posse P, Aaronson ST, Berger MA, Zajecka J, Banov MD, Manu LM, Sheline YI, Farrington J, Eloge JC, Beard J, Kriedt CL, Gott BM, Brown H, Bunker MT, Lee YL, Rush AJ, Sackeim HA, Conway CR. Suicide characteristics in patients with marked treatment-resistant major depressive disorder: A RECOVER trial report. J Affect Disord. 2025 Apr 1;374:619-629. doi: 10.1016/j.jad.2024.12.072. Epub 2024 Dec 24.

    PubMed 39722333

  • Conway CR, Aaronson ST, Sackeim HA, George MS, Zajecka J, Bunker MT, Duffy W, Stedman M, Riva-Posse P, Allen RM, Quevedo J, Berger M, Alva G, Malik MA, Dunner DL, Cichowicz I, Banov M, Manu L, Nahas Z, Macaluso M, Mickey BJ, Sheline Y, Kriedt CL, Lee YL, Gordon C, Shy O, Tran Q, Yates L, Rush AJ. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimul. 2025 May-Jun;18(3):676-689. doi: 10.1016/j.brs.2024.12.1191. Epub 2024 Dec 18.

    PubMed 39706521

  • Rush AJ, Conway CR, Aaronson ST, George MS, Riva-Posse P, Dunner DL, Zajecka J, Bunker MT, Quevedo J, Allen RM, Alva G, Luing H, Nahas Z, Manu L, Bennett JI, Mickey BJ, Becker J, Sheline Y, Cusin C, Murrough JW, Reeves K, Rosenquist PB, Lee YL, Majewski S, Way J, Olin B, Sackeim HA. Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial. Brain Stimul. 2025 May-Jun;18(3):690-700. doi: 10.1016/j.brs.2024.12.1187. Epub 2024 Dec 18.

    PubMed 39701918

  • Conway CR, Aaronson ST, Sackeim HA, Duffy W, Stedman M, Quevedo J, Allen RM, Riva-Posse P, Berger MA, Alva G, Malik MA, Dunner DL, Cichowicz I, Luing H, Zajecka J, Nahas Z, Mickey BJ, Kablinger AS, Kriedt CL, Bunker MT, Lee YL, Shy O, Majewski S, Olin B, Tran Q, Rush AJ. Clinical characteristics and treatment exposure of patients with marked treatment-resistant unipolar major depressive disorder: A RECOVER trial report. Brain Stimul. 2024 Mar-Apr;17(2):448-459. doi: 10.1016/j.brs.2024.03.016. Epub 2024 Apr 2.

    PubMed 38574853

Questions about this trial

What is this clinical trial studying?

A study testing Vagus Nerve Stimulation (VNS) in people with Treatment Resistant Depression, run by LivaNova at 101 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Yates, BSN (281-228-7200, laura.yates@livanova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response (time frame: 12 months post randomization). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887715, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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RECOVER Clinical Trial NCT03887715 | AzTrials