Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03887715
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2019-03-21
Brief Title:
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
Sponsor:
LivaNova
Organization:
LivaNova
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVER
Brief Summary:
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
Detailed Description:
A prospective multi-center randomized controlled blinded trial of subjects implanted with VNS Therapy Active treatment and no stimulation control are randomized at least two weeks after implantation and observed for 12-months
After completing the 12 month endpoint in the RCT portion of the study all RECOVER subjects will transition into the prospective open-label longitudinal portion of the study Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint
After completion of enrollment in the RCT portion or meeting of interim success criterion whichever comes first up to 5800 new subjects may enroll directly into the open-labelprospective longitudinal study These subjects will participate in the study for approximately 5 years
The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development CED decision entitled Decision Memo for Vagus Nerve Stimulation VNS for Treatment Resistant Depression TRD CAG-00313R2
After completing the 12 month endpoint in the RCT portion of the study all RECOVER subjects will transition into the prospective open-label longitudinal portion of the study Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint
After completion of enrollment in the RCT portion or meeting of interim success criterion whichever comes first up to 5800 new subjects may enroll directly into the open-labelprospective longitudinal study These subjects will participate in the study for approximately 5 years
The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development CED decision entitled Decision Memo for Vagus Nerve Stimulation VNS for Treatment Resistant Depression TRD CAG-00313R2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None