Vagus Nerve Stimulation for Treatment Resistant Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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)

Where it's running

• Centre Hospitalier Charles Perrens
  Bordeaux, France, France Recruiting
• CHU Clermont-Ferrand, Hôpital Gabriel Montpied
  Clermont-Ferrand, France, France Recruiting
• APHP. Hôpitaux Universitaires Henri Mondor, Hôpital Henri Mondor
  Créteil, France, France Recruiting
• CHU Dijon, Hôpital Le Bocage
  Dijon, France, France Recruiting
• CHU Grenoble Alpes
  Grenoble, France, France Recruiting
• CHU Lille
  Lille, France, France Recruiting

Study contacts

• Study coordinator: Philippe DOMENECH, MD, MSc
• Email: philippe.domenech@ghu-paris.fr
• Phone: (0) 1 45 65 76 65

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

  This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.

  Recruiting at 10 sites Fondation FondaMental · Besançon and 16 other locations · NCT07881016

• DHEA add-on to standard antidepressants for treatment-resistant depression

  This trial tests whether adding 100 mg/day of DHEA to patients’ current antidepressant treatment helps people with treatment-resistant depression feel better.

  Recruiting at 9 sites Phase 3 Charite University, Berlin, Germany · Berlin, State of Berlin and 8 other locations · NCT07843927

• One-Day cTBS Over the Precuneus and iTBS Over the Left PFC for Treatment-Resistant Depression

  This study tests whether a one-day accelerated TMS session targeting the precuneus or the left dorsolateral prefrontal cortex can reduce depressive symptoms in adults with treatment-resistant depression, compared with sham stimulation.

  Recruiting Mclean Hospital · Belmont, Massachusetts · NCT07758010

• Predicting Treatment Response in Psychiatric Disorders Using Biological Markers

  This study tests whether biological markers can predict which patients with psychiatric conditions will respond to treatment.

  Recruiting Centre Hospitalier St Anne · Paris · NCT07741981

• Cannabidiol Oil as an Add-on for Treatment-Resistant Major Depression

  This study tests whether full-spectrum CBD oil added to standard antidepressants can help adults with treatment-resistant major depression.

  Recruiting Phase 1/2 Universidade do Sul de Santa Catarina · Tubarão, Santa Catarina · NCT07696871

• Biomarker-guided antidepressant choice to see if rTMS or ketamine works best for you

  This study tests whether brain and behavior markers can help match people with major depression to either rTMS or ketamine to see which works better for them.

  Recruiting at 2 sites Phase 4 Weill Medical College of Cornell University · New York, New York and 1 other locations · NCT07680140

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.