The Centers for Medicare and Medicaid Services accepted the London-based company’s protocol for a clinical trial to study the safety and effectiveness of adding VNS to traditional depression treatment in patients with treatment-resistant depression.
Approval of the multi-center, randomized, controlled, blinded trial follows a CMS decision in February to cover Medicare patients enrolled in the study. Separate from the trial, CMS is also covering device replacement for patients with a VNS therapy device for treatment-resistant depression.
“Now that the RECOVER study protocol has been finalized, we are ready to activate sites that will enroll patients in this important study,” said LivaNova CEO Damien McDonald in a news release. “Those who suffer from depression that is difficult to treat may gain access through this study to a potentially life-altering treatment option. We worked with CMS and leading experts in psychiatry to develop the study protocol in accordance with the agency’s NCD (national coverage determination). With depression as the leading cause of disability in the U.S., Medicare coverage is vital for these patients.”
RECOVER is a placebo-controlled study with a follow-up duration of at least one year. The Medicare coverage decision also includes the possibility to extend the study to a prospective longitudinal study. Enrollment is expected to begin in late 2019 and will include up to 500 unipolar and up to 500 bipolar patients at a maximum of 100 sites in the United States.
“In previous studies, we have seen VNS Therapy for TRD (treatment-resistant depression) be highly effective and significantly improve response and remission rates when used as an adjunctive therapy,” said principal investigator Dr. Charles Conway, director of the Washington University Center for Advancement of Research in Resistant Mood and Affective Disorders. “I am eager to help facilitate this study to learn more about the effectiveness of VNS for TRD, and to begin helping more patients who desperately need better treatment. While the enrollment and study itself will take time, we have already created positive momentum that will have tremendous impact.”
More information about the protocol will be available at ClinicalTrials.gov.
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