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

Last updated: December 17, 2024
Sponsor: LivaNova
Overall Status: Terminated

Phase

N/A

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT04753385
LND300
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

All Subjects

  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 ofmajority 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 personalGoogle user account;

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

  3. Agrees to download and maintain the phone application onto personal Androidsmartphone for the duration of the sub-study;

Study Watch

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

Exclusion

Exclusion Criteria:

All Subjects

  1. Any condition or situation the Principal Investigator determines as inappropriatefor study inclusion

Phone Application

No additional exclusion criteria for phone application

Study Watch

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

Study Design

Total Participants: 138
Study Start date:
March 23, 2021
Estimated Completion Date:
September 06, 2024

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • ATP Clinical Research, Inc.

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Keck Hospital of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • SF-Care, Inc.

    San Rafael, California 94901
    United States

    Site Not Available

  • Kind Research Group

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Mindful Behavioral Health

    Boca Raton, Florida 33431
    United States

    Active - Recruiting

  • Segal Trials Corporate

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • Central Miami Medical Institute, LLC

    Miami, Florida 33125
    United States

    Site Not Available

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • Nova Psychiatry Inc.

    Orlando, Florida 32803
    United States

    Site Not Available

  • Advanced Mental Health Care Inc.

    Royal Palm Beach, Florida 33411
    United States

    Site Not Available

  • Florida Center for TMS

    Saint Augustine, Florida 94901
    United States

    Site Not Available

  • Stedman Clinical Trials

    Tampa, Florida 33613
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • AMR-Baber Research, Inc.

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Psychiatric Medicine Associates, LLC

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62794
    United States

    Site Not Available

  • Beacon Medical Group Behavioral Health

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Aaronson

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • Sheppard Pratt Health Systems

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Psychiatric Care and Research

    O'Fallon, Missouri 633668
    United States

    Site Not Available

  • PsychCare Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Alivation Research, LLC

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate

    Buffalo, New York 14215
    United States

    Site Not Available

  • Hapworth Research Inc.

    New York, New York 10019
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Center for Neuropsychiatry and Brain Stimulation (CNBS)

    Cary, North Carolina 27519
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Rivus Wellness & Research Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • OU-SOCM Dept of Psychiatry

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Scranton Medical Institutes

    Moosic, Pennsylvania 18507
    United States

    Site Not Available

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania 19104-4283
    United States

    Site Not Available

  • BioBehavioral Research of Austin

    Austin, Texas 78759
    United States

    Active - Recruiting

  • UT Health Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • UT Center of Excellence on Mood Disorders

    Houston, Texas 77054
    United States

    Site Not Available

  • North Pointe Psychiatry

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Neuropsychiatric Associates, Plc

    Woodstock, Vermont 05091
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Seattle Neuropsychiatric Treatment Center

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Center for Anxiety and Depression

    Mercer Island, Washington 98040
    United States

    Site Not Available

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