RecruitingNot ApplicableNCT05952674

Treatment Resistant Depression and Vagus Nerve Stimulation

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

166 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating vagus nerve stimulation (VNS) — a procedure where a small device is implanted to send electrical signals to the brain via a nerve in the neck — as a treatment for severe, long-lasting depression that has not responded to multiple other treatments. **You may be eligible if...** - You are 18 or older with treatment-resistant depression (recurrent depressive disorder, persistent depressive disorder, or bipolar disorder) - You have had your condition for at least 5 years - Your depression has persisted for at least 12 months in the past 2 years despite trying at least four treatments at proper doses, OR you are currently receiving or have received electroconvulsive therapy (ECT) - Women of childbearing potential must use effective contraception for the duration of the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a diagnosis of schizophrenia, schizoaffective disorder, or persistent delusional disorder - You have had a depressive episode with psychotic features in the last 3 months - You are unable to understand or follow the study protocol - You are under compulsory psychiatric treatment orders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVagus Nerve Stimulation (VNS)

The surgical intervention for the implantation of the VNS medical device is performed by a neurosurgeon under general anesthesia and lasts about an hour. Two incisions are made on the left: one incision to implant an electrode wrapped around the vagus nerve, the other incision to implant the stimulator. The electrode and the stimulator are connected by a cable tunneled. The cardiac tolerance is usually tested at the end of the surgery by turning on the neurostimulator for a few minutes. The stimulator is turned on about two weeks after the implantation, and after the neurosurgeon has checked the quality of healing. The settings used in first intention are standardized and derived from the parameters usually used for the treatment of epilepsies: a pulse width of 250μs, a stimulation frequency of 30Hz, and a 30sec stimulation cycle (ON) every 5min (OFF). Intensity is progressively increased by steps of 0.25mA to reach the 1.5-2mA range, depending on stimulation-induced side effects.

OTHERBest Medical Treatment

Best Medical Treatment for resistant depression.


Locations(23)

CHU Angers

Angers, France

Centre Hospitalier Charles Perrens

Bordeaux, France

CHU Caen

Caen, France

CHU Clermont-Ferrand, Hôpital Gabriel Montpied

Clermont-Ferrand, France

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

Colombes, France

APHP. Hôpitaux Universitaires Henri Mondor, Hôpital Henri Mondor

Créteil, France

CHU Dijon, Hôpital Le Bocage

Dijon, France

CHU Grenoble Alpes

Grenoble, France

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

Issy-les-Moulineaux, France

AP-HP. Université Paris Saclay, Hôpital Bicêtre

Le Kremlin-Bicêtre, France

CHU Lille

Lille, France

Hospices Civils de Lyon, Hôpital Pierre Wertheimer

Lyon, France

Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception

Marseille, France

CHU de Nantes, Hôtel Dieu

Nantes, France

CHU Nice, Hôpital Pasteur 1

Nice, France

AP-HP. Sorbonne Université, Hôpital La Pitié Salpetrière

Paris, France

GHU Paris Psychiatrie & Neuroscience, site Saint Anne

Paris, France

Centre Hospitalier Henri Laborit

Poitiers, France

Centre Hospitalier Guillaume Regnier

Rennes, France

CHU Rouen, Centre Hospitalier du Rouvray

Rouen, France

CHU Saint-Etienne

Saint-Etienne, France

CHU Toulouse, Hôpital de Psychiatrie

Toulouse, France

CHRU Tours, Clinique Psychiatrique Universitaire

Tours, France

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NCT05952674


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