NCT03887715 (RECOVER) is a NA clinical trial of Vagus Nerve Stimulation (VNS) in Treatment Resistant Depression, sponsored by LivaNova.

Who is sponsoring NCT03887715?

NCT03887715 is sponsored by LivaNova.

What drugs are being tested in NCT03887715?

Interventions in NCT03887715: Vagus Nerve Stimulation (VNS).

What condition does NCT03887715 study?

NCT03887715 studies Treatment Resistant Depression.

Is NCT03887715 still recruiting?

NCT03887715 is currently recruiting now. Last updated 26 January 2026.

Last reviewed 2026-01-26 · How we verify

NCT03887715: RECOVER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now NA Last updated 26 January 2026

What this trial tests

NA trial testing Vagus Nerve Stimulation (VNS) in Treatment Resistant Depression in 6,800 participants. Currently enrolling.

Timeline

26 September 2019

Primary endpoint
28 February 2028

31 December 2030

Quick facts

Lead sponsor	LivaNova
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	6,800
Start date	26 September 2019
Primary completion	28 February 2028
Estimated completion	31 December 2030
Sites	98 locations across United States

Drugs / interventions tested

Vagus Nerve Stimulation (VNS)

Conditions studied

Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

LivaNova — full company profile →

Who can join

18 and older, any sex, with Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

A Comprehensive Review of Vagus Nerve Stimulation for Depression.
Austelle CW, O'Leary GH, Thompson S, Gruber E, et al · · 2022 · cited 121× · PMID 35396067 · DOI 10.1111/ner.13528
Device-Based Modulation of Neurocircuits as a Therapeutic for Psychiatric Disorders.
Deng ZD, Luber B, Balderston NL, Velez Afanador M, et al · · 2020 · cited 39× · PMID 31914895 · DOI 10.1146/annurev-pharmtox-010919-023253
The Future Is Noninvasive: A Brief Review of the Evolution and Clinical Utility of Vagus Nerve Stimulation.
Badran BW, Austelle CW. · · 2022 · cited 23× · PMID 35746934 · DOI 10.1176/appi.focus.20210023
Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study.
Young AH, Juruena MF, De Zwaef R, Demyttenaere K. · · 2020 · cited 16× · PMID 32993573 · DOI 10.1186/s12888-020-02869-6
Future directions in psychiatric neurosurgery: Proceedings of the 2022 American Society for Stereotactic and Functional Neurosurgery meeting on surgical neuromodulation for psychiatric disorders.
Hitti FL, Widge AS, Riva-Posse P, Malone DA, et al · · 2023 · cited 15× · PMID 37217075 · DOI 10.1016/j.brs.2023.05.011
The Long and Winding Road of Vagus Nerve Stimulation: Challenges in Developing an Intervention for Difficult-to-Treat Mood Disorders.
Sackeim HA, Dibué M, Bunker MT, Rush AJ. · · 2020 · cited 9× · PMID 33364761 · DOI 10.2147/ndt.s286977
Neurosurgical neuromodulation therapy for psychiatric disorders.
Ranjan M, Mahoney JJ, Rezai AR. · · 2024 · cited 8× · PMID 38688105 · DOI 10.1016/j.neurot.2024.e00366
Shaping plasticity with non-invasive brain stimulation in the treatment of psychiatric disorders: Present and future.
George MS, Caulfield KA, Wiley M. · · 2022 · cited 8× · PMID 35034757 · DOI 10.1016/b978-0-12-819410-2.00028-x

Verify or expand the search:

Other trials of Vagus Nerve Stimulation (VNS)

Trials testing the same drug.

NCT05952674 — Treatment Resistant Depression and Vagus Nerve Stimulation · NA · recruiting
NCT04359004 — A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation · NA · completed
NCT04088565 — VNS-induced Corticospinal Plasticity · NA · completed

Other recruiting trials for Treatment Resistant Depression

Currently open trials in the same condition.

NCT07183748 — Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression · Phase 2 · recruiting
NCT06938841 — Maintenance rTMS for Depression (Maitr-De) · NA · recruiting
NCT06236711 — Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) · NA · active not recruiting
NCT05774665 — Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression · Phase 2 · active not recruiting
NCT06895863 — COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression · NA · recruiting

Other LivaNova trials

Trials by the same sponsor.

NCT05975931 — IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes. · terminated
NCT04950894 — Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation · NA · active not recruiting
NCT04779814 — Non-interventional Study Describing Healthcare Resource Utilisation and Clinical Outcomes Associated With VNS Therapy in · terminated
NCT04753385 — The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment mea · terminated
NCT04282681 — XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU) · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03887715 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LivaNova
Last refreshed: 26 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03887715.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing