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 (RECOVER)

STUDY OVERVIEW

This study sponsored by LivaNova is a prospective, multi-center trial involving subjects who have undergone implantation with VNS Therapy. Subjects are randomly assigned to either active treatment or no stimulation control, and observed for 12 months. Following this period, all subjects transition into a prospective, open-label, longitudinal study. Control subjects are activated after completing the 12-month endpoint. Additionally, up to 5,800 new subjects may enroll directly in the open-label study for approximately 5 years. The study aligns with Centers for Medicare and Medicaid Services coverage with evidence development decision for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD).

STUDY GOALS

This study is a prospective, multi-center trial involving subjects who have undergone implantation with VNS Therapy. Subjects are randomly assigned to either active treatment or no stimulation control, and observed for 12 months. Following this period, all subjects transition into a prospective, open-label, longitudinal study. Control subjects are activated after completing the 12-month endpoint. Additionally, up to 5,800 new subjects may enroll directly into the open-label study for approximately 5 years. The study aligns with Centers for Medicare and Medicaid Services coverage with evidence development decision for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD).

LOCATION

El Paso, Texas: Texas Tech University Health Sciences Center at El Paso

INCLUSION CRITERIA

  • Patients must have a diagnosis of major depressive disorder (MDD) lasting at least two years, or have had at least four episodes of MDD, including the current one.

  • Patients must have failed at least four prior treatments of adequate dose and duration for depression.

  • Patients must be experiencing a major depressive episode (MDE) as confirmed by depression assessment tools on two separate visits within 45 days before VNS device implantation.

  • Patients must maintain a stable medication regimen for at least four weeks before device implantation.

exclusion criteria

  • Patients with current or past psychotic features during any depressive episode.

  • Patients with current or past schizophrenia, schizoaffective disorder, or any other psychotic disorder.

  • Patients with current or past rapid cycling bipolar disorder.

  • Patients with current delirium, dementia, amnesia, or other cognitive disorders.

  • Patients with current suicidal intent.

  • Patients currently undergoing treatment with other investigational devices or drugs.

For more information, visit ClinicalTrials.gov.