LND300

About this trial

Last updated 3 years ago

Study ID

LND300

Status

Recruiting

Type

Observational

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 7 months ago

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).

Inclusion Criteria

1. Current consented subject in the RECOVER clinical trial;

2. Adult (i.e. ≥ 18 years of age, unless a resident of any U.S. state where the age of majority is 19, in which case must be ≥ 19 years of age);

3. Able and willing to provide written informed consent for this sub-study;

4. Able and willing to comply with all study procedures;

5. Able to read and speak English. Phone Application

1. Have a personal Google user account or be willing to create and own a personal Google user account;

2. Owns a personal Android smartphone with a data plan and is the sole user of that smartphone;

3. Agrees to download and maintain the phone application onto personal Android smartphone for the duration of the sub-study; Study Watch

1. Willing to comply with Study Watch wearing and recharging requirements

Exclusion Criteria

1. Any condition or situation the Principal Investigator determines as inappropriate for study inclusion Phone Application No additional exclusion criteria for phone application Study Watch

1. Subjects with known severe allergy to nickel or metal jewelry