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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Angers
ACTIVE_NOT_RECRUITING
Angers
Centre Hospitalier Charles Perrens
RECRUITING
Bordeaux
CHU Caen
NOT_YET_RECRUITING
Caen
CHU Clermont-Ferrand, Hôpital Gabriel Montpied
RECRUITING
Clermont-ferrand
AP-HP. Nord - Université de Paris, Hôpital Louis Mourier
WITHDRAWN
Colombes
APHP. Hôpitaux Universitaires Henri Mondor, Hôpital Henri Mondor
NOT_YET_RECRUITING
Créteil
CHU Dijon, Hôpital Le Bocage
RECRUITING
Dijon
CHU Grenoble Alpes
RECRUITING
Grenoble
AP-HP. Centre - Université de Paris, Hôpital Corentin-Celton
WITHDRAWN
Issy-les-moulineaux
AP-HP. Université Paris Saclay, Hôpital Bicêtre
WITHDRAWN
Le Kremlin-bicêtre
CHU Lille
RECRUITING
Lille
Hospices Civils de Lyon, Hôpital Pierre Wertheimer
NOT_YET_RECRUITING
Lyon
Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception
NOT_YET_RECRUITING
Marseille
CHU de Nantes, Hôtel Dieu
RECRUITING
Nantes
CHU Nice, Hôpital Pasteur 1
RECRUITING
Nice
AP-HP. Sorbonne Université, Hôpital La Pitié Salpetrière
ACTIVE_NOT_RECRUITING
Paris
GHU Paris Psychiatrie & Neuroscience, site Saint Anne
RECRUITING
Paris
Centre Hospitalier Henri Laborit
NOT_YET_RECRUITING
Poitiers
Centre Hospitalier Guillaume Regnier
NOT_YET_RECRUITING
Rennes
CHU Rouen, Centre Hospitalier du Rouvray
RECRUITING
Rouen
CHU Saint-Etienne
RECRUITING
Saint-etienne
CHU Toulouse, Hôpital de Psychiatrie
RECRUITING
Toulouse
CHRU Tours, Clinique Psychiatrique Universitaire
RECRUITING
Tours
Contact Information
Primary
Philippe DOMENECH, MD, MSc
philippe.domenech@ghu-paris.fr
(0) 1 45 65 76 65
Backup
Fabien VINCKIER, MD, MSc
f.vinckier@ghu-paris.fr
(0) 1 45 65 84 52
Time Frame
Start Date: 2024-09-19
Estimated Completion Date: 2030-08-19
Participants
Target number of participants: 166
Treatments
Experimental: Vagus Nerve Stimulation (VNS) + Best Medical Treatment (BMT)
Along with the Optimal Medical Treatment for resistant depression, the VNS + BMT arm will be implanted a medical device of VNS.
Active_comparator: Best Medical Treatment
The BMT arm will only receive the Optimal Medical Treatment for resistant depression.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris
Collaborators: LivaNova

This content was sourced from clinicaltrials.gov