NCT04753385

The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to collect both active and passive data using a wearable, multi-sensor device (Verily Study Watch) and phone application (Mood App) which aims to capture mental health status, in subjects participating in the RECOVER clinical trial (A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression).

Detailed description

A prospective, observational, exploratory study collecting passive and active behavioral, environmental and physiological data, via the use of an Android smartphone application and Study Watch. This sub-study is only open to sites participating in the RECOVER clinical study. All subjects participating in the RECOVER clinical trial at active UNCOVER sites will be offered participation in this sub-study. Subjects who opt-in to the Mood App portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the Mood App portion of the sub-study. Subjects who opt-in to the use of the Study Watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the Study Watch portion of the sub-study.

Conditions

• Treatment Resistant Depression

Timeline

• Start date: 2021-03-23
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2021-02-15
• Last updated: 2024-12-20

Locations

33 sites across 1 country: United States