Treatment Resistant Depression and Vagus Nerve Stimulation (DepVNS)
Treatment Resistant Depression (TRD)
About this trial
This is an interventional treatment trial for Treatment Resistant Depression (TRD) focused on measuring Treatment Resistant Depression (TRD), Vagus Nerve Stimulation (VNS), Best Medical Treatment (BMT)
Eligibility Criteria
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 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 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Vagus Nerve Stimulation (VNS) + Best Medical Treatment (BMT)
Best Medical Treatment
Along with the Optimal Medical Treatment for resistant depression, the VNS + BMT arm will be implanted a medical device of VNS.
The BMT arm will only receive the Optimal Medical Treatment for resistant depression.