LivaNova has announced that the 150th bipolar depression patient has been randomised in its RECOVER clinical study—a prospective, multicentre, double-blinded randomised controlled trial investigating the safety and effectiveness of the company’s vagus nerve stimulation (VNS) therapy system as an adjunct versus no-stimulation controls in subjects with treatment-resistant depression.
The RECOVER protocol allows for a minimum of 150 and a maximum of 500 bipolar depression patients to be randomised into the study. Now, having randomised the 150th bipolar patient, a series of interim analyses will be conducted by an independent Statistical Analysis Committee to assess if predictive probability of success has been reached for the bipolar cohort of the study.
“The RECOVER study is progressing well having completed enrolment for the unipolar patient cohort at 500 and now achieving a major milestone with 150 bipolar patients randomised in this ground-breaking depression study,” said Charles Conway (Washington University Resistant Mood Disorders Center, St Louis, USA), who serves as principal investigator for RECOVER. “As we move through the major milestones of this study, we are taking incremental steps toward offering another treatment option for this significantly impaired patient population.”
RECOVER is the largest clinical study of its kind, LivaNova claims, examining up to 1,000 patients aged 18 years or older who have unipolar or bipolar depression that is difficult to treat. The study is assessing how VNS therapy can offer patients relief from their depressive symptoms and improve quality of life.
“Through RECOVER, we are evaluating the effectiveness of VNS therapy as a treatment for patients who suffer from depression that is difficult to treat,” said William Kozy, interim chief executive officer and board chair of LivaNova. “We look forward to analysing each cohort in the study—bipolar and unipolar—once enrolment concludes, and patients complete their 12-month follow-up visit. From there, we will conduct a final analysis and publish study results for each cohort.”
Launched in September 2019, RECOVER is being carried out at up to 100 leading hospitals and medical centres across the USA. The trial, if successful, will be used to support a peer-reviewed article and reconsideration of reimbursement for VNS therapy by US Centers for Medicare & Medicaid Services (CMS) in the treatment of depression that is difficult to treat, according to LivaNova.
