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

NCT ID: NCT04753385

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-23

Study Completion Date

2024-09-06

Brief Summary

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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

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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

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Treatment Resistant Depression

Keywords

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Depression TRD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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


Study Watch

1\. Subjects with known severe allergy to nickel or metal jewelry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LivaNova

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Conway, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Site Status

Keck Hospital of USC

Los Angeles, California, United States

Site Status

SF-Care, Inc.

San Rafael, California, United States

Site Status

Kind Research Group

Boca Raton, Florida, United States

Site Status

APG Research, LLC

Orlando, Florida, United States

Site Status

Nova Psychiatry Inc.

Orlando, Florida, United States

Site Status

Advanced Mental Health Care Inc.

Royal Palm Beach, Florida, United States

Site Status

Florida Center for TMS

Saint Augustine, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

Augusta University

Augusta, Georgia, United States

Site Status

AMR-Baber Research, Inc.

Naperville, Illinois, United States

Site Status

Psychiatric Medicine Associates, LLC

Skokie, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Beacon Medical Group Behavioral Health

South Bend, Indiana, United States

Site Status

Sheppard Pratt Health Systems

Baltimore, Maryland, United States

Site Status

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

Site Status

Psychiatric Care and Research

O'Fallon, Missouri, United States

Site Status

PsychCare Consultants Research

St Louis, Missouri, United States

Site Status

Alivation Research, LLC

Lincoln, Nebraska, United States

Site Status

Hapworth Research Inc.

New York, New York, United States

Site Status

Center for Neuropsychiatry and Brain Stimulation (CNBS)

Cary, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

OU-SOCM Dept of Psychiatry

Tulsa, Oklahoma, United States

Site Status

Scranton Medical Institutes

Moosic, Pennsylvania, United States

Site Status

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

UT Health Austin

Austin, Texas, United States

Site Status

UT Center of Excellence on Mood Disorders

Houston, Texas, United States

Site Status

North Pointe Psychiatry

Lewisville, Texas, United States

Site Status

Neuropsychiatric Associates, Plc

Woodstock, Vermont, United States

Site Status

Carilion Clinic

Roanoke, Virginia, United States

Site Status

Seattle Neuropsychiatric Treatment Center

Bellevue, Washington, United States

Site Status

Center for Anxiety and Depression

Mercer Island, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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LND300

Identifier Type: -

Identifier Source: org_study_id