Back to all studies
RecruitingNCT03887715

Effectiveness of VNS Therapy® System in treatment-resistant depression

The registry lists this study as recruiting. Study locations are listed in the United States. Confirm recruitment at each site. It is testing VNS Therapy® System for treatment-resistant depression.

DepressionDeviceOver 18 Years
In plain English

Key information made simple

What is this study testing?

This study is testing whether brain stimulation may be useful for adults experiencing depression.

What would participation involve?

Participants may take part in brain stimulation, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about how many sessions are required and who delivers them, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: September 26, 2019
Recruitment status
Recruiting
Enrollment listed in the registry
6,800
Sponsor
LivaNova
Sponsor type
Unknown or unclear
Study type
Device
Intervention type
DEVICE
Study phase
Not clearly listed
Locations
United States
Age range
Over 18 Years
Official registry ID
NCT03887715
Official title
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

Want help reviewing this study?

Loading the security check...
Study ID: NCT03887715. We help you review the study, but cannot decide medical eligibility.

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

United States · 101 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama
    Site status: Recruiting
  • UAB Huntsville Regional Medical Center
    Huntsville, Alabama
    Site status: Recruiting
  • Access Multi Specialty Medical Clinic, Inc
    Burlingame, California
    Site status: Terminated
  • CMB Clinical Trials
    Colton, California
    Site status: Withdrawn
  • ATP Clinical Research, Inc.
    Costa Mesa, California
    Site status: Recruiting
  • Kaizen Brain Center
    La Jolla, California
    Site status: Recruiting
  • Keck Hospital of USC
    Los Angeles, California
    Site status: Recruiting
  • University of California San Diego
    San Diego, California
    Site status: Active Not Recruiting
  • SF-CARE, Inc.
    San Rafael, California
    Site status: Terminated
  • Syrentis Clinical Research
    Santa Ana, California
    Site status: Withdrawn
  • Sunrise Research Institute
    Boca Raton, Florida
    Site status: Terminated
  • Mindful Behavioral Health
    Boca Raton, Florida
    Site status: Recruiting
  • Medycal Research, Inc
    Brooksville, Florida
    Site status: Terminated
  • Galiz Research LLC
    Hialeah, Florida
    Site status: Recruiting
  • Flourish Research - St. Augustine
    Jacksonville, Florida
    Site status: Recruiting
  • Florida Behavioral Psych
    Largo, Florida
    Site status: Recruiting
  • Segal Trials Corporate
    Lauderhill, Florida
    Site status: Withdrawn
  • Central Miami Medical Institute, LLC
    Miami, Florida
    Site status: Withdrawn
  • Clintex Research Group, Inc.
    Miami, Florida
    Site status: Terminated
  • Research Center Of Florida, Inc
    Miami, Florida
    Site status: Withdrawn
  • Ocean Blue Medical Research Center
    Miami Springs, Florida
    Site status: Withdrawn
  • APG Research, LLC
    Orlando, Florida
    Site status: Recruiting
  • Nova Psychiatry Inc.
    Orlando, Florida
    Site status: Recruiting
  • Florida Center for TMS
    Orlando, Florida
    Site status: Terminated
  • Millenia Psychiatry & Research, Inc
    Orlando, Florida
    Site status: Withdrawn
  • Quantum Laboratories Inc.
    Pompano Beach, Florida
    Site status: Terminated
  • dTMS Center, LCC
    Royal Palm Beach, Florida
    Site status: Terminated
  • Florida Center for TMS
    Saint Augustine, Florida
    Site status: Terminated
  • IPTB Clinical Research
    Tampa, Florida
    Site status: Recruiting
  • Stedman Clinical Trials
    Tampa, Florida
    Site status: Terminated
  • K2 Medical Research
    Tampa, Florida
    Site status: Recruiting
  • Psychiatric Specialty Center
    West Palm Beach, Florida
    Site status: Terminated
  • Emory University
    Atlanta, Georgia
    Site status: Recruiting
  • Medical College of Georgia, Augusta University
    Augusta, Georgia
    Site status: Recruiting
  • PACT Atlanta LLC
    Decatur, Georgia
    Site status: Terminated
  • IACT Health
    Grayson, Georgia
    Site status: Withdrawn
  • Psych Atlanta
    Marietta, Georgia
    Site status: Recruiting
  • Pearl Health Clinic
    Ammon, Idaho
    Site status: Withdrawn
  • Rush University Medical Center
    Chicago, Illinois
    Site status: Recruiting
  • Joliet Center For Clinical Research
    Joliet, Illinois
    Site status: Terminated
  • AMR- Baber Research, Inc.
    Naperville, Illinois
    Site status: Recruiting
  • Psychiatric Medicine Associates, LLC
    Skokie, Illinois
    Site status: Recruiting
  • Southern Illinois University School of Medicine
    Springfield, Illinois
    Site status: Recruiting
  • Neuroscience Research Institute
    Winfield, Illinois
    Site status: Withdrawn
  • Advanced Research Institute, Inc.
    Indianapolis, Indiana
    Site status: Terminated
  • Beacon Medical Group Behavioral Health
    South Bend, Indiana
    Site status: Active Not Recruiting
  • University Of Kansas Cancer Center
    Kansas City, Kansas
    Site status: Recruiting
  • Sheppard Pratt Health System, Inc.
    Baltimore, Maryland
    Site status: Recruiting
  • Clinical Insights
    Glen Burnie, Maryland
    Site status: Withdrawn
  • Massachusetts General Hospital
    Boston, Massachusetts
    Site status: Recruiting
  • Michigan Clinical Research Institute PC
    Ann Arbor, Michigan
    Site status: Recruiting
  • University of Minnesota
    Minneapolis, Minnesota
    Site status: Recruiting
  • Precise Research Centers
    Flowood, Mississippi
    Site status: Recruiting
  • Andrew Bishop, MD
    Jackson, Mississippi
    Site status: Terminated
  • University of Missouri
    Columbia, Missouri
    Site status: Recruiting
  • Psychiatric Care and Research
    O'Fallon, Missouri
    Site status: Recruiting
  • Washington University School of Medicine
    St Louis, Missouri
    Site status: Recruiting
  • PsychCare Consultants Research
    St Louis, Missouri
    Site status: Terminated
  • Alivation Research, LLC
    Lincoln, Nebraska
    Site status: Recruiting
  • Healthy Perspective
    Nashua, New Hampshire
    Site status: Recruiting
  • Jersey Shore University Medical Center
    Neptune City, New Jersey
    Site status: Withdrawn
  • University of New Mexico - Psychiatric Center
    Albuquerque, New Mexico
    Site status: Withdrawn
  • Dent Neurological Institute
    Amherst, New York
    Site status: Recruiting
  • Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
    Buffalo, New York
    Site status: Withdrawn
  • Trinity Medical
    Lewiston, New York
    Site status: Recruiting
  • Hapworth Research Inc.
    New York, New York
    Site status: Terminated
  • Icahn School of Medicine at Mount Sinai
    New York, New York
    Site status: Recruiting
  • Richmond Behavioral Associates
    Staten Island, New York
    Site status: Withdrawn
  • Stony Brook University Hospital
    Stony Brook, New York
    Site status: Terminated
  • State University Of New York Upstate Medical University
    Syracuse, New York
    Site status: Terminated
  • ManuMind Interventional Psychiatry
    Woodbury, New York
    Site status: Recruiting
  • The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health
    Cary, North Carolina
    Site status: Terminated
  • Mindpath Care Centers
    Raleigh, North Carolina
    Site status: Terminated
  • Wake Forest University Health Science
    Winston-Salem, North Carolina
    Site status: Withdrawn
  • University Hospitals Case Medical Center
    Cleveland, Ohio
    Site status: Withdrawn
  • The Ohio State University
    Columbus, Ohio
    Site status: Recruiting
  • Signature Research Associates, Inc.
    Fairlawn, Ohio
    Site status: Active Not Recruiting
  • Charak Center for Health and Wellness
    Garfield Heights, Ohio
    Site status: Recruiting
  • NPC Research
    Oklahoma City, Oklahoma
    Site status: Withdrawn
  • Rivus Wellness & Research Institute
    Oklahoma City, Oklahoma
    Site status: Terminated
  • University of Oklahoma School of Community Medicine
    Tulsa, Oklahoma
    Site status: Recruiting
  • Scranton Medical Institutes
    Moosic, Pennsylvania
    Site status: Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania
    Site status: Recruiting
  • Medical University of South Carolina
    Charleston, South Carolina
    Site status: Recruiting
  • Neuroscience and TMS Treatment Center
    Brentwood, Tennessee
    Site status: Recruiting
  • UT Health Austin, Mulva Clinic for the Neurosciences
    Austin, Texas
    Site status: Recruiting
  • BioBehavioral Research of Austin
    Austin, Texas
    Site status: Terminated
  • University of Texas Southwestern
    Dallas, Texas
    Site status: Recruiting
  • Texas Tech University Health Science Center
    El Paso, Texas
    Site status: Recruiting
  • The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders
    Houston, Texas
    Site status: Recruiting
  • Houston Clinical Trials
    Houston, Texas
    Site status: Terminated
  • Northpointe Psychiatry
    Lewisville, Texas
    Site status: Recruiting
  • Rise Clinical Research, LLC
    Missouri City, Texas
    Site status: Terminated
  • The University of Utah
    Salt Lake City, Utah
    Site status: Recruiting
  • Neuropsychiatric Associates, Plc
    Woodstock, Vermont
    Site status: Terminated
  • Carilion Clinic
    Roanoke, Virginia
    Site status: Recruiting
  • Center For Anxiety and Depression
    Mercer Island, Washington
    Site status: Recruiting
  • Seattle Neuropsychiatric Treatment Center
    Seattle, Washington
    Site status: Recruiting
  • Marshall University Joan C. Edwards School of Medicine
    Huntington, West Virginia
    Site status: Recruiting
  • West Virginia Clinical and Translational Science Institute
    Morgantown, West Virginia
    Site status: Withdrawn
  • University of Wisconsin
    Madison, Wisconsin
    Site status: Recruiting
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medical device for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a device, app, or technology?

This appears to be a device / app / digital / technology study involving Vagus Nerve Stimulation (VNS). The phase is not clearly listed in the public registry. Phase is mostly relevant for medication studies and some device studies. For this study, it may be more useful to look at what is required, the duration, visits, and eligibility criteria.

Who might this study be for?

This study may concern people with depression; age range: Over 18 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to use a device, app, or digital tool for a defined period. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What should I check about data, monitoring, alerts, and daily use?

If the study uses a device, app, or digital tool, check what data is collected, who can access it, how often you need to use it, and what happens if the tool detects a concerning signal. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by LivaNova, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

Explore other studies

Want to find a study that may fit you better?

Answer a few simple questions to explore HopeStage studies by condition, country, and situation.

Find a study that may fit me