The Recover clinical will gather quantitative data on patient behavior using Verily’s technology and analytics. The data could help the researchers understand depressive episodes and the patient’s response to treatment.
Study participants will be offered the Verily Study Watch, which is designed to capture physiological and environmental data for clinical research, along with a Verily mobile phone app to help investigators better understand the impact of depression and its treatment.
LivaNova enrolled its first patient in the Recover study in September 2019. At the time, the company planned to enroll up to 500 unipolar and up to 500 bipolar patients across as many as 100 sites in the U.S. for the double-blinded, randomized, placebo-controlled study. Recover has a follow-up duration slated for 1 year and a possibility to extend to a prospective longitudinal study.
“The goal of the Recover study is to assess how VNS therapy can offer patients with DTD relief from their symptoms and improve their quality of life,” LivaNova CEO Damien McDonald said in a news release. “Through this collaboration with Verily, we can build on our work to study depression and better understand the complex elements that contribute to the disorder, enhancing our ability to treat the patients who battle it.”
Recover patients with an Android device can opt-in to a sub-study to use the Verily Study Watch and a mobile phone app designed to measure passive and interactive data. The companies said the data collected there will offer a more comprehensive view of the condition of a patient’s depression.
The Verily Study Watch is capable of measuring heart rate, activity level, sleep quality and other functions. It also collects patient-recorded voice logs to accurately assess depression and its effect on daily life.
“Finding new solutions to help those who suffer from [DTD] promises to truly transform patients’ lives,” Verily head of clinical science & neurology Dr. William Marks said. “We look forward to working with LivaNova to gather additional data and evidence on VNS Therapy for [DTD] with the potential for collaboration on other areas of research in the future.”