A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression. (RESTORE-LIFE)
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- STATUS
- Recruiting
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- End date
- Dec 1, 2025
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- participants needed
- 500
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- sponsor
- LivaNova
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.
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 maximum 5 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.
Details
| Condition | Treatment Resistant Depression |
|---|---|
| Treatment | Vagal Nerve Simulation (VNS) Therapy |
| Clinical Study Identifier | NCT03320304 |
| Sponsor | LivaNova |
| Last Modified on | 1 March 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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