LivaNova, Verily Begin Difficult-to-Treat Depression Study

LivaNova and Verily have enrolled the first patient in their collaborative UNCOVER study or “The RECOVER Sub-Study, Which Leverages Quantitative and Credible Research Tools from Verily, Will Provide Assessment Measures for Depressive Episodes.”
 
UNCOVER is an opt-in research study for patients in the ongoing LivaNova clinical study RECOVER or “A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy as Adjunctive Therapy Versus a No Stimulation Control in Subjects with Treatment-Resistant Depression.” The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate VNS Therapy’ real-word efficacy as an adjunctive treatment for difficult-to-treat depression (DTD).
 
UNCOVER sub-study patients will use two Verily-developed digital tools: a wearable, multi-sensor device (Verily Study Watch) and Android smartphone app (Verily Mood App). The tools measure passive and active data, such as the participant’s pulse rate, activity levels, and sleep quality. The Mood App also allows recording voice diaries to more accurately assess depressive episodes and their effect on daily living.
 
“After detailed planning with our colleagues at LivaNova, we are pleased to have launched the UNCOVER study and enrolled the first participant,” Dr. William Marks, Head of Clinical Science and Neurology at Verily, told the press. “These Verily tools will collect behavioral, environmental, and physiological data from study participants, with the goal of painting a clearer picture of depressive episodes and the impact depression has on individual’s lives over the course of the study.”
 
Quantitative data obtained from these Verily tools will supplement the clinical outcomes collected in the RECOVER study, providing clinicians a more comprehensive view of whether each patient’s depression is improving, staying the same, or worsening.
 
Depression continues to be an important health concern globally and an area in need of more effective treatments. Research shows the number of adults experiencing depression in the U.S. has tripled in recent times. Before the pandemic, 8.5 percent of U.S. adults reported being depressed, whereas that number has risen to 27.8 percent as the country deals with COVID-19.¹
 
“For as many as one in three patients, medication alone may not be enough to combat depression that is difficult to treat,”2 said Damien McDonald, CEO of LivaNova. “As we re-confirm the effectiveness of VNS Therapy in treating depression through the RECOVER study, we hope to learn even more through the UNCOVER sub-study about each patient’s journey and the daily improvements in their lives with the use of Verily tools so we can provide the most effective treatment for this disorder.”
 
Launched in September 2019, RECOVER is studying up to 1,000 people ages 18 or older with difficult-to-treat depression or bipolar depression. The double-blind, randomized, placebo-controlled study is assessing how VNS Therapy can offer patients relief from their DTD symptoms and improve quality of life. Symmetry, the LivaNova VNS Therapy System for depression, is the first and only FDA-approved implantable device specifically designed for DTD. RECOVER is being carried out at up to 100 leading hospitals and medical centers across the United States. RECOVER subjects from participating sites who own an Android smartphone are being offered the option to participate in the UNCOVER sub-study, with a maximum of 300 subjects to be enrolled. LivaNova and Verily announced their collaboration on UNCOVER in February 2020.
 
Reference
¹ Ettman, C, Abdalla, S, Cohen G, et al. Prevalence of Depression Symptoms in U.S. Adults Before and During the COVID-19 Pandemic. JAMA Network Open. 2020;3(9):e2019686. doi:10.1001/jamanetworkopen.2020.19686.
² STARD: Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905–1917.