LivaNova, a market-leading medical technology, and innovation company, and Verily, a subsidiary of Alphabet focused on life sciences and healthcare, announced that the first patient has been enrolled 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 taking part 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 the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression (DTD).
Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device (Verily Study Watch) along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels, and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living, LivaNova said in a news release.
“After detailed planning with our colleagues at LivaNova, we are pleased to have launched the UNCOVER study and enrolled the first participant,” said Dr. William Marks, Head of Clinical Science and Neurology at Verily. “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 with 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% of U.S. adults reported being depressed, whereas that number has risen to 27.8% as the country deals with COVID-19.
“For as many as one in three patients, medication alone may not be enough to combat depression that is difficult to treat,” said Damien McDonald, Chief Executive Officer 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 who have depression or bipolar depression that has been difficult to treat. 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.