History of Changes for Study: NCT04753385

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

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Study Record Versions

Version	Submitted Date	Changes
1	February 10, 2021	None (earliest Version on record)
2	April 2, 2021	Recruitment Status, Study Status and Contacts/Locations
3	May 4, 2021	Study Status and Contacts/Locations
4	June 3, 2021	Study Status and Contacts/Locations
5	August 10, 2021	Study Status and Contacts/Locations
6	September 16, 2021	Study Status and Contacts/Locations
7	March 23, 2022	Contacts/Locations and Study Status
8	May 14, 2024	Recruitment Status, Contacts/Locations and Study Status

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Merged
Side-by-Side

Study Identification


Unique Protocol ID:	LND300
Brief Title:	The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes (UNCOVER)
Official Title:	The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
Secondary IDs:

Study Status


Record Verification:	May 2024
Overall Status:	Active, not recruiting
Study Start:	March 23, 2021
Primary Completion:	October 2024 [Anticipated]
Study Completion:	October 2024 [Anticipated]

First Submitted:	January 7, 2021
First Submitted that Met QC Criteria:	February 10, 2021
First Posted:	February 15, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	May 14, 2024
Last Update Posted:	May 16, 2024 [Actual]

Sponsor/Collaborators


Sponsor:	LivaNova
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief 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 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.

Conditions


Conditions:	Treatment Resistant Depression
Keywords:	Depression TRD

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	300 [Anticipated]
Number of Groups/Cohorts	0

Groups and Interventions

Outcome Measures


Primary Outcome Measures:
1.	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
2.	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
3.	Number of ping sensor recordings [ Time Frame: Through study completion; Average 2 years ] Number of ping sensor recordings over the duration of the study
4.	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

Eligibility


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.
Sampling Method:	Non-Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: All Subjects Current consented subject in the RECOVER clinical trial; 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); Able and willing to provide written informed consent for this sub-study; Able and willing to comply with all study procedures; Able to read and speak English. Phone Application Have a personal Google user account or be willing to create and own a personal Google user account; Owns a personal Android smartphone with a data plan and is the sole user of that smartphone; 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

Contacts/Locations


Study Officials:	Charles Conway, MD Principal Investigator Washington University School of Medicine
Locations:	United States, Alabama
	University of Alabama at Birmingham Birmingham, Alabama, United States, 35294
	United States, California
	ATP Clinical Research, Inc. Costa Mesa, California, United States, 92626
	Keck Hospital of USC Los Angeles, California, United States, 90033
	SF-Care, Inc. San Rafael, California, United States, 94901
	United States, Florida
	Kind Research Group Boca Raton, Florida, United States, 33431
	APG Research, LLC Orlando, Florida, United States, 32803
	Nova Psychiatry Inc. Orlando, Florida, United States, 32803
	Advanced Mental Health Care Inc. Royal Palm Beach, Florida, United States, 33411
	Florida Center for TMS Saint Augustine, Florida, United States, 94901
	Stedman Clinical Trials Tampa, Florida, United States, 33613
	United States, Georgia
	Augusta University Augusta, Georgia, United States, 30912
	United States, Illinois
	AMR-Baber Research, Inc. Naperville, Illinois, United States, 60563
	Psychiatric Medicine Associates, LLC Skokie, Illinois, United States, 60076
	Southern Illinois University School of Medicine Springfield, Illinois, United States, 62794
	United States, Indiana
	Beacon Medical Group Behavioral Health South Bend, Indiana, United States, 46601
	United States, Maryland
	Sheppard Pratt Health Systems Baltimore, Maryland, United States, 21204
	United States, Michigan
	Michigan Clinical Research Institute PC Ann Arbor, Michigan, United States, 48105
	United States, Missouri
	Psychiatric Care and Research O'Fallon, Missouri, United States, 633668
	PsychCare Consultants Research Saint Louis, Missouri, United States, 63128
	United States, Nebraska
	Alivation Research, LLC Lincoln, Nebraska, United States, 68526
	United States, New York
	Hapworth Research Inc. New York, New York, United States, 10019
	United States, North Carolina
	Center for Neuropsychiatry and Brain Stimulation (CNBS) Cary, North Carolina, United States, 27519
	United States, Ohio
	Ohio State University Columbus, Ohio, United States, 43210
	United States, Oklahoma
	OU-SOCM Dept of Psychiatry Tulsa, Oklahoma, United States, 74135
	United States, Pennsylvania
	Scranton Medical Institutes Moosic, Pennsylvania, United States, 18507
	University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania, United States, 19104-4283
	United States, Texas
	UT Health Austin Austin, Texas, United States, 78712
	UT Center of Excellence on Mood Disorders Houston, Texas, United States, 77054
	North Pointe Psychiatry Lewisville, Texas, United States, 75057
	United States, Vermont
	Neuropsychiatric Associates, Plc Woodstock, Vermont, United States, 05091
	United States, Virginia
	Carilion Clinic Roanoke, Virginia, United States, 24014
	United States, Washington
	Seattle Neuropsychiatric Treatment Center Bellevue, Washington, United States, 98004
	Center for Anxiety and Depression Mercer Island, Washington, United States, 98040

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