Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05952674 En recrutement IDF

Titre

Resistant Depression and Vagus Nerve Stimulation : a Medico-economic, Multicenter, Randomized and Open Trial (DepVNS)

Type

Interventional

Pathologie

Dépression
Trouble dépressif
Trouble dépressif résistant aux traitements

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

septembre 2024

Date de fin

août 2030

Dernière mise à jour

23 mai 2025

Résumé

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.

Détail

Voir le détail 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. The term treatment-resistant depression (TRD) is used when two or more (and often many more) well conducted antidepressant treatments from different classes have failed to achieve remission. Depression has a major impact on quality of life, socio-professional functioning and healthcare consumption. According to the World Health Organization (WHO), depression will be the second cause of healthcare costs in the world by 2020. RD alone accounts for 30 to 40% of the annual cost of depression. Sometimes, TRD is part of a bipolar illness, a psychiatric condition characterized by the alternation of depressive and maniac episodes that affects 4% of the population. In this case, the challenge is even bigger because (1) antidepressants are no well tolerated, further reducing the therapeutic options in case of resistance, (2) 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. Bipolar RD currently accounts for 20% of all psychiatric spending. 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 because of the frequency and the intensity of the memory disorders associated, the repetition of anesthesia and hospitalizations and its social stigma. Refusals and requests to stop ECT are therefore common even when it is effective, as these constraints are sometimes experienced as being unbearable in the long-term. 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 the 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. VNS has been approved for over 15 years as a treatment for RD in the Unites States and Great-Britain. The 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. The secondary objectives are evaluating the efficacy and the security of the VNS, as well as positioning the VNS in comparison with ECT that is currently the standard treatment for TRD. This is a national multicenter comparative, open, randomized, controlled, two-parallel group clinical trial evaluating the medico-economic impact of VNS in resistant depression population. Patients (166) suffering from resistant depression will be enrolled over a 24-month period and will be randomized in a (1:1) ratio to receive either Vagus Nerve Stimulation (VNS) along with the Best Medical Treatment (VNS+BMT arm) or the Optimal Medical Treatment only (BMT arm). Patients meeting all eligibility criteria will be enrolled in the study. All subjects will be followed by the investigators or designee of the investigator during the whole study period by visits on site. Number of visits/participant: Both arms will attend: selection visit (VS), inclusion visit (VI) and randomization visit (R), M0, M2, M4, M6, M8, M10, M12, M14, M16, M18, M20, M22 and M24. After the inclusion visit, the experimental arm (VNS + BMT) will further attend a neurosurgical and anesthetic consultation before being hospitalized for the VNS system placement. The patient will finally be hospitalized in psychiatry for about 5 days for switching the device on. If the target intensity has not been reached during this hospitalization, an adjustment visit is planned every month for 6 months in order to progressively increase the stimulation intensity until the target or a therapeutic response. If the target or the therapeutic response is obtained, the settings adjustments rhythm will be at the indiscretion of the psychiatrist. If at the end of the 6 first visits (M1 to M6), the target intensity couldn't be reached or in absence of a satisfying clinical response, a visit will be planned every 3 months (consultation or hospitalization) to keep optimizing the VNS. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Corentin Celton		Annulé	Contact (sur clinicalTrials)
AP-HP - Hôpital Henri Mondor-Albert Chenevier	Charles LAIDI, Dr	Recrutement non commencé	Contact (sur clinicalTrials)
AP-HP - Hôpital Louis Mourier		Annulé	Contact (sur clinicalTrials)
GHU PARIS PSY ET NEUROSCIENCES	Philippe DOMENECH, Pr	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP. Sorbonne Université, Hôpital La Pitié Salpetrière - 75013 - Paris - France		Active, sans recrutement	Contact (sur clinicalTrials)
AP-HP. Université Paris Saclay, Hôpital Bicêtre - 94270 - Le Kremlin-Bicêtre - France		Annulé	Contact (sur clinicalTrials)
Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception - 13005 - Marseille - France	Raphaëlle RICHIERI, Dr	Recrutement non commencé	Contact (sur clinicalTrials)
Centre Hospitalier Charles Perrens - 33076 - Bordeaux - France	Thomas BIENVENU, Dr	En recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Guillaume Regnier - 35703 - Rennes - France	Dominique DRAPIER, Pr	Recrutement non commencé	Contact (sur clinicalTrials)
Centre Hospitalier Henri Laborit - 86021 - Poitiers - France	Nematollah JAAFARI, Pr	Recrutement non commencé	Contact (sur clinicalTrials)
CHRU Tours, Clinique Psychiatrique Universitaire - 37540 - Tours - France	Wissam EL HAGE, Pr	En recrutement	Contact (sur clinicalTrials)
CHU Angers - 49933 - Angers - France		Active, sans recrutement	Contact (sur clinicalTrials)
CHU Caen - 14000 - Caen - France	Sonia DOLLFUS, Pr	Recrutement non commencé	Contact (sur clinicalTrials)
CHU Clermont-Ferrand, Hôpital Gabriel Montpied - 63000 - Clermont-Ferrand - France	Ludovic SAMALIN, Pr	En recrutement	Contact (sur clinicalTrials)
CHU de Nantes, Hôtel Dieu - 44093 - Nantes - France	Anne SAUVAGET, Pr	En recrutement	Contact (sur clinicalTrials)
CHU Dijon, Hôpital Le Bocage - 21000 - Dijon - France	Jean-Christophe CHAUVET-GELINIER, Pr	En recrutement	Contact (sur clinicalTrials)
CHU Grenoble Alpes - 38700 - Grenoble - France	Mircea POLOSAN, Pr	En recrutement	Contact (sur clinicalTrials)
CHU Lille - 59037 - Lille - France	Ali AMAD, Pr	En recrutement	Contact (sur clinicalTrials)
CHU Nice, Hôpital Pasteur 1 - 06001 - Nice - France	Bruno GIORDANA, Dr	En recrutement	Contact (sur clinicalTrials)
CHU Rouen, Centre Hospitalier du Rouvray - 76300 - Rouen - France	Olivier GUILLIN, Pr	En recrutement	Contact (sur clinicalTrials)
CHU Saint-Etienne - 42055 - Saint-Etienne - France	Éric FAKRA, Pr	En recrutement	Contact (sur clinicalTrials)
CHU Toulouse, Hôpital de Psychiatrie - 31059 - Toulouse - France	Antoine YRONDI, Dr	En recrutement	Contact (sur clinicalTrials)
Hospices Civils de Lyon, Hôpital Pierre Wertheimer - 69677 - Lyon - France	Emmanuel POULET, Pr	Recrutement non commencé	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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 and criteria A before the start of the
ECT treatment or ECT dependency criteria

- Patients who, after the nature of the study has been explained to them, have given
written consent

Critère de non inclusion

- 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 clinical trial, excepted
eventual ancillary researches validated by the study scientific committee.
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)

NCT05952674 - Resistant Depression and Vagus Nerve Stimulation : a Medico-economic, Multicenter, Randomized and Open Trial (DepVNS)

Informations générales
Etablissements
Critères
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