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

Comparison Format:

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 2021
Overall Status:	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 4, 2021
Last Update Posted:	May 5, 2021 [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


Central Contact Person:	Shannon L Majewski Telephone: (817) 771-9195 Email: shannon.majewski@livanova.com
Central Contact Backup:	Jeff Way Telephone: (281) 228-7394 Email: jeffrey.way@livanova.com
Study Officials:	Charles Conway, MD Principal Investigator Washington University School of Medicine
Locations:	United States, California
	ATP Clinical Research, Inc. [Recruiting] Costa Mesa, California, United States, 92626 Contact:Contact: Bobby Shih 714-277-4472 bshih@atpcr.com Contact:Principal Investigator: Gustavo Alva, MD
	United States, Florida
	APG Research, LLC [Recruiting] Orlando, Florida, United States, 32803 Contact:Contact: Matt Bubal 407-808-1875 apgresearch.bubalo@gmail.com Contact:Principal Investigator: Morteza Nadjafi, MD
	Stedman Clinical Trials [Recruiting] Tampa, Florida, United States, 33613 Contact:Contact: Susan Fowler 813-971-8311 susan_fowler@stedmanclinicaltrials.com Contact:Principal Investigator: Mary L Stedman, MD
	United States, Illinois
	Psychiatric Medicine Associates, LLC [Recruiting] Skokie, Illinois, United States, 60076 Contact:Contact: Amanda White 847-679-8000 Ext. 12 awhite.pma@gmail.com Contact:Principal Investigator: John Zajecka, MD
	United States, Indiana
	Beacon Medical Group Behavioral Health [Recruiting] South Bend, Indiana, United States, 46601 Contact:Contact: Vanessa DePue, RN 574-647-6584 Vdepue@beaconhealthsystem.org Contact:Principal Investigator: Ahmed Elmaadawi, MD
	United States, Michigan
	Michigan Clinical Research Institute PC [Recruiting] Ann Arbor, Michigan, United States, 48105 Contact:Contact: Amanda Szczesniak 734-834-8954 Ext. 2 amandas@earlytreatment.org Contact:Principal Investigator: Rajaprabhakaran Rajarethinam, MD
	United States, Nebraska
	Alivation Research, LLC [Recruiting] Lincoln, Nebraska, United States, 68526 Contact:Contact: Kelly Espenschade 402-817-2235 KEspenschade@alivation.com Contact:Principal Investigator: Walter Duffy, MD
	United States, New York
	Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate [Recruiting] Buffalo, New York, United States, 14215 Contact:Contact: Sevie Kandefer 716-898-4038 sk293@buffalo.edu Contact:Principal Investigator: Biswarup Ghosh, MD
	Hapworth Research Inc. [Recruiting] New York, New York, United States, 10019 Contact:Contact: Mariah Garcia 212-956-2000 mgarcia@treatmentonline.com Contact:Principal Investigator: William Hapworth, MD
	United States, Oklahoma
	Rivus Wellness & Research Institute [Recruiting] Oklahoma City, Oklahoma, United States, 73112 Contact:Contact: Marvin Peyton (PI), MD 405-753-4994 drpeyton@rivusinstitute.com
	United States, Texas
	BioBehavioral Research of Austin [Recruiting] Austin, Texas, United States, 78759 Contact:Contact: Candice Peel 512-382-6661 candice@bbraustin.com Contact:Principal Investigator: Charles Sweet, MD
	North Pointe Psychiatry [Recruiting] Lewisville, Texas, United States, 75057 Contact:Contact: Sahar Ashraf 469-444-2244 sahar_ashraf07@yahoo.com Contact:Principal Investigator: Asad Islam, MD
	United States, Vermont
	Neuropsychiatric Associates, Plc [Recruiting] Woodstock, Vermont, United States, 05091 Contact:Contact: Susan Shaw 802-457-4904 sshaw@woodstockresearch.org Contact:Principal Investigator: Susan Smiga, MD
	United States, Washington
	Center for Anxiety and Depression [Recruiting] Mercer Island, Washington, United States, 98040 Contact:Contact: Heidi Brandli 206-230-0330 hbrandli@comcast.net Contact:Principal Investigator: David Dunner, MD

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