Vagus Nerve Stimulation for Treatment Resistant Depression

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

This study is testing if Vagus Nerve Stimulation can help adults with treatment-resistant depression feel better when combined with their current medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 23 sites (Angers and 22 other locations)
• Trial ID: NCT05952674 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Vagus Nerve Stimulation (VNS) as a treatment for patients suffering from Treatment Resistant Depression (TRD). The study aims to enroll adults who have not responded to multiple antidepressant treatments and may also include those with bipolar disorder. Participants will receive VNS in conjunction with the best medical treatment available. The goal is to assess the effectiveness of this combined approach in improving depressive symptoms and overall quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of recurrent depressive disorder or bipolar disorder who have not responded to at least four different antidepressant treatments.

Not a fit: Patients who are currently pregnant, breastfeeding, or have schizophrenia may not receive any benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with severe and persistent depression who have not benefited from traditional treatments.

How similar studies have performed: Previous studies have shown promise in using Vagus Nerve Stimulation for treatment-resistant depression, indicating that this approach may be effective.

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)

Where this trial is running

Angers and 22 other locations

• CHU Angers — Angers, France (ACTIVE_NOT_RECRUITING)
• Centre Hospitalier Charles Perrens — Bordeaux, France (RECRUITING)
• CHU Caen — Caen, France (NOT_YET_RECRUITING)
• CHU Clermont-Ferrand, Hôpital Gabriel Montpied — Clermont-Ferrand, France (RECRUITING)
• AP-HP. Nord - Université de Paris, Hôpital Louis Mourier — Colombes, France (WITHDRAWN)
• APHP. Hôpitaux Universitaires Henri Mondor, Hôpital Henri Mondor — Créteil, France (NOT_YET_RECRUITING)
• CHU Dijon, Hôpital Le Bocage — Dijon, France (RECRUITING)
• CHU Grenoble Alpes — Grenoble, France (RECRUITING)
• AP-HP. Centre - Université de Paris, Hôpital Corentin-Celton — Issy-les-Moulineaux, France (WITHDRAWN)
• AP-HP. Université Paris Saclay, Hôpital Bicêtre — Le Kremlin-Bicêtre, France (WITHDRAWN)
• CHU Lille — Lille, France (RECRUITING)
• Hospices Civils de Lyon, Hôpital Pierre Wertheimer — Lyon, France (NOT_YET_RECRUITING)
• Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception — Marseille, France (NOT_YET_RECRUITING)
• CHU de Nantes, Hôtel Dieu — Nantes, France (RECRUITING)
• CHU Nice, Hôpital Pasteur 1 — Nice, France (RECRUITING)
• AP-HP. Sorbonne Université, Hôpital La Pitié Salpetrière — Paris, France (ACTIVE_NOT_RECRUITING)
• GHU Paris Psychiatrie & Neuroscience, site Saint Anne — Paris, France (RECRUITING)
• Centre Hospitalier Henri Laborit — Poitiers, France (NOT_YET_RECRUITING)
• Centre Hospitalier Guillaume Regnier — Rennes, France (NOT_YET_RECRUITING)
• CHU Rouen, Centre Hospitalier du Rouvray — Rouen, France (RECRUITING)
• CHU Saint-Etienne — Saint-Etienne, France (RECRUITING)
• CHU Toulouse, Hôpital de Psychiatrie — Toulouse, France (RECRUITING)
• CHRU Tours, Clinique Psychiatrique Universitaire — Tours, France (RECRUITING)

Study contacts

• Study coordinator: Philippe DOMENECH, MD, MSc

Conditions: Treatment Resistant Depression, Vagus Nerve Stimulation, Best Medical Treatment