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Could a nerve stimulator in the neck beat severe depression?

NCT ID NCT05952674

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This trial investigates whether vagus nerve stimulation (VNS) — a device implanted in the neck that sends electrical pulses to the brain — can help people with treatment-resistant depression. About 166 adults with depression that has not responded to standard treatments will receive either VNS plus usual care or usual care alone. The study measures if VNS is worth its cost by tracking mood, quality of life, and healthcare use over two years.

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) device
What this could lead to
If effective, VNS could offer a long-term maintenance treatment option for people with treatment-resistant depression, potentially reducing relapse and improving quality of life.
What could go wrong
This is an open-label, randomized trial, so results may be influenced by placebo effects. VNS requires surgery and carries risks like infection or nerve damage. The study focuses on cost-effectiveness, not just clinical benefit.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 166 people

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

Started

Feb 2024

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: * Patients aged 18 years and older ; * Childbearing women must have an efficient contraception for the whole study period * Diagnosis of recurrent depressive trouble or persistent depressive disorder or bipolar disorder (according to DSM-5) * Start of disorder (defined by the occurrence of the first thymus episode: characterized depressive disorder or maniac episode with or without mixed characteristics) for 5 years or more * At least one of the following criteria: * Criterion A: current characterized depressive disorder and characterized depressive disorder for at least 12 months during the last 24 months despite at least four treatments lines at appropriate dosage and duration * Criterion B: current treatment by ECT/(Es)Ketamine/TMS and criteria A before the start treatment or ECT/(Es)Ketamine/TMS dependency * Patients who, after the nature of the study has been explained to them, have given written consent Exclusion Criteria: * Know pregnancy or breastfeeding * Schizophrenia, schizoaffective disorder or persistent delusional disorder (DSM-5) * Characterized depressive disorder with psychotic characteristics within 3 months before the inclusion (DSM-5) * Concomitant participation to another interventional research not authorized by the coordinating investigator or the scientific lead. Participation to non-interventional researches is allowed. * Patients receiving enforced cares (ASPDT, ASPPI, ASPDRE, etc.) * Non-affiliation to a social security regimen or any other social protection regimen * Disability, according to the investigator, to understand the study or refusal to sign the study consent form (non-francophone patient, cognitive disorders) * Anticipated disability to attend all the visits, treatments and measures planned by the protocol: severe personality disorder, severe substance addiction, severe intellectual development disorder. In any of those cases, the notion of severity is at the indiscretion of the investigator Secondary Exclusion Criteria: * Surgical contraindication to the VNS * Positive β-HCG (results obtained after the informed consent is signed but before the randomization)

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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 (TRD)

How to take part

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

  1. The places running it

    19 sites. 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

  • AP-HP. Centre - Université de Paris, Hôpital Corentin-Celton

    WITHDRAWN

    Issy-les-Moulineaux, France

  • AP-HP. Nord - Université de Paris, Hôpital Louis Mourier

    WITHDRAWN

    Colombes, France, 92700, France

  • AP-HP. Sorbonne Université, Hôpital La Pitié Salpetrière

    ACTIVE_NOT_RECRUITING

    Paris, France, 75013, France

  • AP-HP. Université Paris Saclay, Hôpital Bicêtre

    WITHDRAWN

    Le Kremlin-Bicêtre, France, 94270, France

  • APHP. Hôpitaux Universitaires Henri Mondor, Hôpital Henri Mondor

    RECRUITING

    Créteil, France, 94000, France

  • Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception

    NOT_YET_RECRUITING

    Marseille, France, 13005, France

  • CHRU Tours, Clinique Psychiatrique Universitaire

    RECRUITING

    Tours, France, 37540, France

  • CHU Angers

    ACTIVE_NOT_RECRUITING

    Angers, France, 49933, France

  • CHU Brest

    NOT_YET_RECRUITING

    Brest, 29200, France

  • CHU Caen

    NOT_YET_RECRUITING

    Caen, France, 14000, France

  • CHU Clermont-Ferrand, Hôpital Gabriel Montpied

    RECRUITING

    Clermont-Ferrand, France, 63000, France

  • CHU Dijon, Hôpital Le Bocage

    RECRUITING

    Dijon, France, 21000, France

  • CHU Grenoble Alpes

    RECRUITING

    Grenoble, France, 38700, France

  • CHU Lille

    RECRUITING

    Lille, France, 59037, France

  • CHU Nice, Hôpital Pasteur 1

    RECRUITING

    Nice, France, 06001, France

  • CHU Rouen, Centre Hospitalier du Rouvray

    RECRUITING

    Rouen, France, 76300, France

  • CHU Saint-Etienne

    RECRUITING

    Saint-Etienne, France, 42055, France

  • CHU Toulouse, Hôpital de Psychiatrie

    RECRUITING

    Toulouse, France, 31059, France

  • CHU de Nantes, Hôtel Dieu

    RECRUITING

    Nantes, France, 44093, France

  • Centre Hospitalier Charles Perrens

    RECRUITING

    Bordeaux, France, 33076, France

  • Centre Hospitalier Guillaume Regnier

    RECRUITING

    Rennes, France, 35703, France

  • Centre Hospitalier Henri Laborit

    NOT_YET_RECRUITING

    Poitiers, France, 86021, France

  • GHU Paris Psychiatrie & Neuroscience, site Saint Anne

    RECRUITING

    Paris, France, 75014, France

  • Hospices Civils de Lyon, Hôpital Pierre Wertheimer

    NOT_YET_RECRUITING

    Lyon, France, 69677, France

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