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

March 23, 2022 updated by: LivaNova
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).

Study Overview

Status

Recruiting

Conditions

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 that currently own an Android smartphone 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 also 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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • Recruiting
        • ATP Clinical Research, Inc.
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Recruiting
        • Mindful Behavioral Health
      • Lauderhill, Florida, United States, 33319
        • Recruiting
        • Segal Trials Corporate
        • Contact:
      • Miami, Florida, United States, 33125
        • Recruiting
        • Central Miami Medical Institute, LLC
      • Orlando, Florida, United States, 32803
        • Recruiting
        • APG Research, LLC
      • Royal Palm Beach, Florida, United States, 33411
        • Recruiting
        • Advanced Mental Health Care Inc.
      • Saint Augustine, Florida, United States, 94901
        • Recruiting
        • Florida Center for TMS
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Stedman Clinical Trials
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Psychiatric Medicine Associates, LLC
      • Springfield, Illinois, United States, 62794
        • Recruiting
        • Southern Illinois University School of Medicine
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Recruiting
        • Beacon Medical Group Behavioral Health
    • Maryland
      • Baltimore, Maryland, United States, 21204
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • Michigan Clinical Research Institute PC
        • Contact:
        • Principal Investigator:
          • Rajaprabhakaran Rajarethinam, MD
    • Missouri
      • O'Fallon, Missouri, United States, 633668
        • Recruiting
        • Psychiatric Care and Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Alivation Research, LLC
    • New York
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
        • Contact:
        • Principal Investigator:
          • Biswarup Ghosh, MD
      • New York, New York, United States, 10019
        • Recruiting
        • Hapworth Research Inc.
      • Syracuse, New York, United States, 13210
        • Withdrawn
        • SUNY Upstate Medical University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Rivus Wellness & Research Institute
    • Pennsylvania
      • Moosic, Pennsylvania, United States, 18507
        • Recruiting
        • Scranton Medical Institutes
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • BioBehavioral Research of Austin
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • North Pointe Psychiatry
        • Contact:
        • Principal Investigator:
          • Asad Islam, MD
    • Vermont
      • Woodstock, Vermont, United States, 05091
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic
    • Washington
      • Mercer Island, Washington, United States, 98040
        • Recruiting
        • Center For Anxiety and Depression
        • Contact:
        • Principal Investigator:
          • David Dunner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This sub-study is only open to sites participating in the RECOVER clinical study.

Every subject that currently owns an Android smartphone will be offered to opt-in to the sub-study.

Description

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 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:

All Subjects

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of PHQ-8 tasks
Time Frame: Through study completion; Average 2 years
Percentage of PHQ-8 tasks completed over the duration of the study
Through study completion; Average 2 years
Percentage of Voice Diary tasks
Time Frame: Through study completion; Average 2 years
Percentage of Voice Diary tasks completed over the duration of the study
Through study completion; Average 2 years
Number of ping sensor recordings
Time Frame: Through study completion; Average 2 years
Number of ping sensor recordings over the duration of the study
Through study completion; Average 2 years
Number of hours of watch wear time
Time Frame: Through study completion; Average 2 years
Number of hours of watch wear time over the duration of the study
Through study completion; Average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2021

Primary Completion (ANTICIPATED)

October 1, 2024

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (ACTUAL)

February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LND300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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