# 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

> **NCT03887715** · NA · RECRUITING · sponsor: **LivaNova** · enrollment: 6800 (estimated)

## Conditions studied

- Treatment Resistant Depression

## Interventions

- **DEVICE:** Vagus Nerve Stimulation (VNS)

## Key facts

- **NCT ID:** NCT03887715
- **Lead sponsor:** LivaNova
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2019-09-26
- **Primary completion:** 2028-02-28
- **Final completion:** 2030-12-31
- **Target enrollment:** 6800 (ESTIMATED)
- **Last updated:** 2026-01-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03887715

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03887715, "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". Retrieved via MORVS 2026-10-16 from https://api.morvs.ai/clinical/NCT03887715. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*