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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Trial testing VNS Therapy for treatment-resistant depression safety and effectiveness.

Recruiting
18 years and older
All
Phase N/A

This study is about finding out if a special treatment called **VNS Therapy** helps people with **treatment-resistant depression**. VNS stands for Vagus Nerve Stimulation, which is a treatment that uses a small device implanted in the body to send electrical pulses to the brain. It's like a pacemaker for the brain! The study will compare people who get the VNS treatment to those who don't, to see who feels better after a year. People who have had depression for a long time or tried many treatments without success can join. They will be watched for 12 months and might continue in a longer study for up to 5 years. The study follows special rules to make sure it's safe and useful.

  • Participants will be part of the study for at least 12 months, with possible continuation for 5 years.
  • Participants must have tried at least four unsuccessful depression treatments before.
  • Participants cannot join if they have certain mental health conditions like schizophrenia.
Study details
    Treatment Resistant Depression

NCT03887715

LivaNova

2 August 2025

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