Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a nerve stimulator beat tough depression? new study tracks Long-Term results

NCT ID NCT03320304

Disease control Sponsor: LivaNova Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study follows 500 people with treatment-resistant depression who receive Vagus Nerve Stimulation (VNS) Therapy, an implanted device that sends electrical pulses to the vagus nerve. Researchers will track how many patients see a 50% or greater improvement in depression scores over 12 months. The goal is to see how well VNS works in everyday medical practice, not just in controlled trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vagus Nerve Stimulation (VNS) Therapy device
What this could lead to
If successful, this could confirm VNS Therapy as a reliable long-term option for people with treatment-resistant depression.
What could go wrong
This is an observational study, not a controlled trial, so results may be less conclusive. The device requires surgery and carries risks like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2017

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management. The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview (MINI).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be at least 18 years of age. * Have a documented primary diagnosis of chronic (\>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. This diagnosis must be confirmed using the MINI. * Provide written Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent and Health Insurance Portability and Accountability Act (HIPAA, US only) authorization (as applicable according to local requirements). * Currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics). * Able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.Hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study) Exclusion Criteria: There are no exclusion criteria; the investigator should refer to the (local applicable) VNS Therapy Physician's Manual.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Treatment-resistant depression are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment-resistant depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AKH Allgemeines Krankenhaus der Stadt Wien

    RECRUITING

    Vienna, 1090, Austria

  • Academic Psychiatry Wolfson Research Centre

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Glenfield hospital

    RECRUITING

    Leicester, LE3 9EJ, United Kingdom

  • KU Leuven

    RECRUITING

    Leuven, Belgium

  • King's College London

    RECRUITING

    London, United Kingdom

  • Klinikum Wilhelmshaven

    ACTIVE_NOT_RECRUITING

    Wilhelmshaven, Germany

  • LVR-Hospital Essen

    RECRUITING

    Essen, 45147, Germany

  • Medizinische Hochschule Hannover

    WITHDRAWN

    Hanover, Germany

  • Mendip HTT / St Andrew's Ward

    ACTIVE_NOT_RECRUITING

    Wells, BA5 1TH, United Kingdom

  • Sozialstiftung Bamberg - Klinikum am Bruderwald

    WITHDRAWN

    Bamberg, Germany

  • University Hospital Münster

    RECRUITING

    Münster, Germany

  • Universitätsklinik Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, Germany

  • Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, Germany

  • Universitätsklinikum Freiburg

    COMPLETED

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Jena

    COMPLETED

    Jena, Germany

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, Germany

  • Universitätsmedizin Göttingen

    WITHDRAWN

    Göttingen, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.