AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Treatment Resistant Depression and Vagus Nerve Stimulation

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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/(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 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 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.) * 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)
💊

What it tests

  • Vagus Nerve Stimulation (VNS)
  • Best Medical Treatment
📍

Where

24 sites
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

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy