RECOVER Study for Treatment Resistant Depression
Protocol: SITE00000124
Full Title
RECOVER: A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy System as AdjunctivETherapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Description
This study enrolls adults ages 18+ with treatment resistant depression. The purpose of this study is to learn about how well active Vagus Nerve Stimulation (VNS) Therapy works for helping people with treatment resistant depression.

You will be in this study for about 5 years and have about 22 visits to our office during that time. You will have a VNS Therapy implanted during the study. You will be randomized (like flipping a coin) to one of two study groups. You will not know which group you are in. One group will get active VNS Therapy and the other group will have the device implanted, but will receive no stimulation from it. You can think of this as one group will have the device turned on and the other group will have it turned off. After 1 year, the group receiving no stimulation will start to receive active VNS Therapy for the remainder of the study (4 years). Study takes place at ECMC (Erie County Medical Center, 462 Grider Street, Buffalo, NY 14215).

Technical Description

(CSR#190956031900) The objective of this study is to determine whether active VNS Therapy treatment improves health outcomes for Treatment Resistant Depression (TRD) subjects compared to a no stimulation control in depressive symptoms.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
-Adults ages 18+.
-Have been diagnosed with a major depressive episode where the antidepressant treatment did not adequately benefit them.
-Please contact the research team to learn about other eligibility criteria for this study.
Age Group: Adults
Principal Investigator: BISWARUP GHOSH
Contact(s)
SEVIE KANDEFER
sk293@buffalo.edu
+1 716-898-4038
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.