Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03320304
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2017-10-05
Brief Title:
A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression
Sponsor:
LivaNova
Organization:
LivaNova
Study Overview
Official Title:
A Global PRospective Multi-cEnter ObServational Post-markeT Study tO Assess shoRt Mid and Long-term Effectiveness and Efficiency of VNS Therapy as Adjunctive Therapy in reaL-world patIents With diFficult to Treat dEpression
Status:
RECRUITING
Status Verified Date:
2024-01
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:
RESTORE-LIFE
Brief Summary:
The primary objective of this study is to assess short mid and long-term clinical outcomes in patients with difficult to treat depression such as patients with treatment resistant depression treated with Vagus Nerve Stimulation VNS Therapy as adjunctive therapy
Detailed Description:
The population under study comprises a real-world patient population with difficult to treat depression patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management
The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview MINI
A minimum of five hundred 500 patients will be implanted with a VNS Therapy System and up to eighty 80 sites may participate in this study
Enrollment will take 8 years based on competitive enrollment For each subject a baseline visit will occur between 1 and 6 weeks before implant
Once implanted with the device subjects will be followed-up for a minimum of 36 months and a maximum of 60 months The study may stop when the last subject has reached the 36 months follow-up
The diagnosis of depression and comorbid disorders will be determined based on the Mini International Neuropsychiatric Interview MINI
A minimum of five hundred 500 patients will be implanted with a VNS Therapy System and up to eighty 80 sites may participate in this study
Enrollment will take 8 years based on competitive enrollment For each subject a baseline visit will occur between 1 and 6 weeks before implant
Once implanted with the device subjects will be followed-up for a minimum of 36 months and a maximum of 60 months The study may stop when the last subject has reached the 36 months follow-up
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?:
None
Is an FDA AA801 Violation?:
None