Tests vagus nerve stimulation for treatment-resistant depression
Tests a implanted nerve device against usual care in adults with depression that resists treatment.
Plain-language title generated from the registry record
Registry title: Treatment Resistant Depression and Vagus Nerve Stimulation
Key facts
- Where
- Angers, Bordeaux, Brest, Caen, Clermont-Ferrand, Colombes, Créteil, Dijon, Grenoble, Issy-les-Moulineaux, Le Kremlin-Bicêtre, Lille, Lyon, Marseille, Nantes, Nice, Paris, Poitiers, Rennes, Rouen, Saint-Etienne, Toulouse, and Tours, FranceSee the 24 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting depression (recurrent, persistent or bipolar) that has not improved with several treatments.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Recurrent depressive disorder, persistent depressive disorder or bipolar disorder, starting 5 years or more ago. Current depression, or depression for at least 12 of the last 24 months despite at least four treatment lines. Or current treatment with ECT, (Es)Ketamine or TMS, or dependence on it.
- Earlier treatment
- At least four treatment lines at appropriate dose and duration, or current ECT, (Es)Ketamine or TMS treatment.
Main reasons for not taking part
- Known pregnancy or breastfeeding
- Schizophrenia, schizoaffective disorder or persistent delusional disorder
- Depression with psychotic features within 3 months before inclusion
- Taking part in another interventional study not authorized by the coordinating investigator or scientific lead
- A surgical reason that rules out vagus nerve stimulation
Read by machine on 12 November 2026.
Where in France
- CHU AngersAngers, FranceContact: Philippe DOMENECH, MD, MScNo longer taking part
- Centre Hospitalier Charles PerrensBordeaux, FranceContact: Thomas BIENVENU, DrTaking people
- Chu BrestBrest, FranceContact: Florian STEPHAN, DrNot yet recruiting
- CHU CaenCaen, FranceContact: Sonia DOLLFUS, PrNot yet recruiting
- CHU Clermont Ferrand - Hôpital Gabriel MontpiedClermont-Ferrand, FranceContact: Ludovic SAMALIN, PrTaking people
- AP-HP. Nord - Université de Paris, Hôpital Louis MourierColombes, FranceContact: Philippe DOMENECH, MD, MScNo longer taking part
- APHP. Hôpitaux Universitaires Henri Mondor, Hôpital Henri MondorCréteil, FranceContact: Charles LAIDI, DrTaking people
- CHU Dijon, Hôpital Le BocageDijon, FranceContact: Jean-Christophe CHAUVET-GELINIER, PrTaking people
- CHU Grenoble AlpesGrenoble, FranceContact: Mircea POLOSAN, PrTaking people
- AP-HP. Centre - Université de Paris, Hôpital Corentin-CeltonIssy-les-Moulineaux, FranceContact: Philippe DOMENECH, MD, MScNo longer taking part
- AP-HP. Université Paris Saclay, Hôpital BicêtreLe Kremlin-Bicêtre, FranceContact: Philippe DOMENECH, MD, MScNo longer taking part
- CHU LilleLille, FranceContact: Ali AMAD, PrTaking people
- Hospices Civils de Lyon, Hôpital Pierre WertheimerLyon, FranceContact: Emmanuel POULET, PrNot yet recruiting
- Assistance Publique Hôpitaux de Marseille, Hôpital de la ConceptionMarseille, FranceContact: Raphaëlle RICHIERI, DrNot yet recruiting
- CHU de Nantes - Hôtel DieuNantes, FranceContact: Anne SAUVAGET, PrTaking people
- CHU Nice, Hôpital Pasteur 1Nice, FranceContact: Bruno GIORDANA, DrTaking people
- GHU Paris Psychiatrie & Neuroscience, site Saint AnneParis, FranceContact: Philippe DOMENECH, PrTaking people
- AP-HP. Sorbonne Université, Hôpital La Pitié SalpetrièreParis, FranceContact: Philippe DOMENECH, MD, MScNo longer taking part
- Centre Hospitalier Henri LaboritPoitiers, FranceContact: Nematollah JAAFARI, PrNot yet recruiting
- Centre hospitalier Guillaume RégnierRennes, FranceContact: Dominique DRAPIER, PrTaking people
- CHU Rouen, Centre Hospitalier du RouvrayRouen, FranceContact: Olivier GUILLIN, PrTaking people
- CHU Saint-EtienneSaint-Etienne, FranceContact: Éric FAKRA, PrTaking people
- CHU Toulouse, Hôpital de PsychiatrieToulouse, FranceContact: Antoine YRONDI, DrTaking people
- CHRU Tours, Clinique Psychiatrique UniversitaireTours, FranceContact: Wissam EL HAGE, PrTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05952674
- Record updated
- 23 June 2026
- Original description
Depression is a common illness, affecting 17% of the population over the course of a lifetime. A third of depressions relapses and progresses to recurrence and resistance to treatments. Despite the optimization of antidepressant medical strategies, 20 to 40% of depressions do not respond to treatment. This is particularly worrying as 6% of non-responder patients will die by committing suicide.Read full original descriptionShow less
Resistant Depression and Vagus Nerve Stimulation : a Medico-economic, Multicenter, Randomized and Open Trial
Depression is a common illness, affecting 17% of the population over the course of a lifetime. A third of depressions relapses and progresses to recurrence and resistance to treatments. Despite the optimization of antidepressant medical strategies, 20 to 40% of depressions do not respond to treatment. This is particularly worrying as 6% of non-responder patients will die by committing suicide.
Depression has a major impact on quality of life, socio-professional functioning and healthcare consumption.
Sometimes, TRD is part of a bipolar illness. In this case, the challenge is even bigger because antidepressants are no well tolerated, further reducing the therapeutic options in case of resistance, the severity and duration of the depressive episodes are the main factors explaining the deterioration of the quality of life and the increasing cost of cares for these patients.
The standard treatment for TRD is electroconvulsive therapy (ECT), which results in a response in 60 to 70% of cases after a few weeks of treatment. However, the improvement is often transient and 40% of patients relapse within 6 months of the initial ECT session. Moreover, ECT is often not well tolerated. This therapeutic impasse therefore makes TRD a priority public health target to which it is urgent to provide a realistic medico-economical response.
The literature suggests that Vagus Nerve Stimulation (VNS) has unique kinetics of efficacy in depression, particularly in preventing long-term recurrences, and therefore responding to the lack of effective maintenance treatment in TRD. In fact, the benefits of VNS gradually accumulate over 12-24 months, which makes it complementary to more incisive treatments like ECT. Finally, its efficacy-tolerance profile appears to be similar in uni and bipolar TRD, giving VNS a potentially unique place in the therapeutic arsenal in psychiatry.
The DepVNS hypothesis is that VNS is a medico-economically efficient therapeutic option to overcome the therapeutic impasse in which patients suffering from uni and bipolar DR currently find themselves due to the frequency of relapses under treatment.
The primary objective is to estimate, from a collective point of view, the incremental cost-utility ratio of VNS to treat patients suffering from RD.
Inclusion: 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: 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.); Surgical contraindication to the VNS; Schizophrenia, schizoaffective disorder or persistent delusional disorder (DSM-5); 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:; Know pregnancy or breastfeeding; Non-affiliation to a social security regimen or any other social protection regimen; Positive β-HCG (results obtained after the informed consent is signed but before the randomization).