ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT03887715
Public ClinicalTrials.gov record NCT03887715. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03887715
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 6,800 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2019
- Primary completion
- Feb 27, 2028
- Completion
- Dec 30, 2030
- Last update posted
- Jun 14, 2026
2019 – 2030
United States locations
- U.S. sites
- 101
- U.S. states
- 32
- U.S. cities
- 88
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Recruiting |
| UAB Huntsville Regional Medical Center | Huntsville | Alabama | 35801 | Recruiting |
| Access Multi Specialty Medical Clinic, Inc | Burlingame | California | 94010 | Terminated |
| CMB Clinical Trials | Colton | California | 92324 | Withdrawn |
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | Recruiting |
| Kaizen Brain Center | La Jolla | California | 92037 | Recruiting |
| Keck Hospital of USC | Los Angeles | California | 90033 | 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 | Withdrawn |
| Sunrise Research Institute | Boca Raton | Florida | 33325 | Terminated |
| Mindful Behavioral Health | Boca Raton | Florida | 33431 | Recruiting |
| Medycal Research, Inc | Brooksville | Florida | 34609 | Terminated |
| Galiz Research LLC | Hialeah | Florida | 33016 | Recruiting |
| Flourish Research - St. Augustine | Jacksonville | Florida | 32216 | Recruiting |
| Florida Behavioral Psych | Largo | Florida | 33770 | Recruiting |
| Segal Trials Corporate | Lauderhill | Florida | 33319 | Withdrawn |
| 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 |
| APG Research, LLC | Orlando | Florida | 32803 | Recruiting |
| Nova Psychiatry Inc. | Orlando | Florida | 32803 | Recruiting |
| Florida Center for TMS | Orlando | Florida | 32806 | Terminated |
| Millenia Psychiatry & Research, Inc | Orlando | Florida | 32819 | Withdrawn |
| Quantum Laboratories Inc. | Pompano Beach | Florida | 33064 | Terminated |
| dTMS Center, LCC | Royal Palm Beach | Florida | 33411 | Terminated |
| Florida Center for TMS | Saint Augustine | Florida | 32086 | Terminated |
| IPTB Clinical Research | Tampa | Florida | 33612 | Recruiting |
| Stedman Clinical Trials | Tampa | Florida | 33613 | Terminated |
| K2 Medical Research | Tampa | Florida | 33634 | Recruiting |
| Psychiatric Specialty Center | West Palm Beach | Florida | 33409 | Terminated |
| Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Medical College of Georgia, Augusta University | Augusta | Georgia | 30912 | Recruiting |
| PACT Atlanta LLC | Decatur | Georgia | 30030 | Terminated |
| IACT Health | Grayson | Georgia | 30017 | Withdrawn |
| Psych Atlanta | Marietta | Georgia | 30060 | Recruiting |
| Pearl Health Clinic | Ammon | Idaho | 83406 | Withdrawn |
| Rush University Medical Center | Chicago | Illinois | 60612 | Recruiting |
| Joliet Center For Clinical Research | Joliet | Illinois | 60435 | Terminated |
| AMR- Baber Research, Inc. | Naperville | Illinois | 60563 | Recruiting |
| Psychiatric Medicine Associates, LLC | Skokie | Illinois | 60076 | Recruiting |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794 | Recruiting |
| Neuroscience Research Institute | Winfield | Illinois | 60910 | Withdrawn |
| Advanced Research Institute, Inc. | Indianapolis | Indiana | 56268 | Terminated |
| Beacon Medical Group Behavioral Health | South Bend | Indiana | 46601 | Active, not recruiting |
| University Of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| Sheppard Pratt Health System, Inc. | Baltimore | Maryland | 21204 | Recruiting |
| Clinical Insights | Glen Burnie | Maryland | 21061 | Withdrawn |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Michigan Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55416 | Recruiting |
| Precise Research Centers | Flowood | Mississippi | 39232 | Recruiting |
| Andrew Bishop, MD | Jackson | Mississippi | 39216 | Terminated |
| University of Missouri | Columbia | Missouri | 65212 | Recruiting |
| Psychiatric Care and Research | O'Fallon | Missouri | 633668 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | Terminated |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | Recruiting |
| Healthy Perspective | Nashua | New Hampshire | 03060 | Recruiting |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | Withdrawn |
| University of New Mexico - Psychiatric Center | Albuquerque | New Mexico | 87102 | Withdrawn |
| Dent Neurological Institute | Amherst | New York | 14226 | Recruiting |
| Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate | Buffalo | New York | 14215 | Withdrawn |
| Trinity Medical | Lewiston | New York | 14092 | Recruiting |
| Hapworth Research Inc. | New York | New York | 10019 | Terminated |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| 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 |
| ManuMind Interventional Psychiatry | Woodbury | New York | 11797 | Recruiting |
| The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health | Cary | North Carolina | 27519 | Terminated |
| Mindpath Care Centers | Raleigh | North Carolina | 27606 | Terminated |
| Wake Forest University Health Science | Winston-Salem | North Carolina | 27103 | Withdrawn |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | Withdrawn |
| The Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Signature Research Associates, Inc. | Fairlawn | Ohio | 44333 | Active, not recruiting |
| Charak Center for Health and Wellness | Garfield Heights | Ohio | 44125 | Recruiting |
| NPC Research | Oklahoma City | Oklahoma | 73109-3834 | Withdrawn |
| Rivus Wellness & Research Institute | Oklahoma City | Oklahoma | 73112 | Terminated |
| University of Oklahoma School of Community Medicine | Tulsa | Oklahoma | 74135 | Recruiting |
| Scranton Medical Institutes | Moosic | Pennsylvania | 18507 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Neuroscience and TMS Treatment Center | Brentwood | Tennessee | 37027 | Recruiting |
| UT Health Austin, Mulva Clinic for the Neurosciences | Austin | Texas | 78712 | Recruiting |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | Terminated |
| University of Texas Southwestern | Dallas | Texas | 75390 | Recruiting |
| Texas Tech University Health Science Center | El Paso | Texas | 79905 | Recruiting |
| The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders | Houston | Texas | 77054 | Recruiting |
| Houston Clinical Trials | Houston | Texas | 77401 | Terminated |
| Northpointe Psychiatry | Lewisville | Texas | 75057 | Recruiting |
| Rise Clinical Research, LLC | Missouri City | Texas | 77459 | Terminated |
| The University of Utah | Salt Lake City | Utah | 84108 | Recruiting |
| Neuropsychiatric Associates, Plc | Woodstock | Vermont | 05091 | Terminated |
| Carilion Clinic | Roanoke | Virginia | 24014 | Recruiting |
| Center For Anxiety and Depression | Mercer Island | Washington | 98040 | Recruiting |
| Seattle Neuropsychiatric Treatment Center | Seattle | Washington | 98104 | Recruiting |
| Marshall University Joan C. Edwards School of Medicine | Huntington | West Virginia | 25701 | Recruiting |
| West Virginia Clinical and Translational Science Institute | Morgantown | West Virginia | 26506 | Withdrawn |
| University of Wisconsin | Madison | Wisconsin | 53719 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03887715, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2026 · Synced Sep 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03887715 live on ClinicalTrials.gov.