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

Treatment Resistant Depression Clinical Trial

— UNCOVER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04753385
• Other study ID #: LND300
• Status: Active, not recruiting
• Start date: March 23, 2021
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Locations

Country	Name	City	State
United States	Michigan Clinical Research Institute PC	Ann Arbor	Michigan
United States	Augusta University	Augusta	Georgia
United States	UT Health Austin	Austin	Texas
United States	Sheppard Pratt Health Systems	Baltimore	Maryland
United States	Seattle Neuropsychiatric Treatment Center	Bellevue	Washington
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Kind Research Group	Boca Raton	Florida
United States	Center for Neuropsychiatry and Brain Stimulation (CNBS)	Cary	North Carolina
United States	Ohio State University	Columbus	Ohio
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	UT Center of Excellence on Mood Disorders	Houston	Texas
United States	North Pointe Psychiatry	Lewisville	Texas
United States	Alivation Research, LLC	Lincoln	Nebraska
United States	Keck Hospital of USC	Los Angeles	California
United States	Center for Anxiety and Depression	Mercer Island	Washington
United States	Scranton Medical Institutes	Moosic	Pennsylvania
United States	AMR-Baber Research, Inc.	Naperville	Illinois
United States	Hapworth Research Inc.	New York	New York
United States	Psychiatric Care and Research	O'Fallon	Missouri
United States	APG Research, LLC	Orlando	Florida
United States	Nova Psychiatry Inc.	Orlando	Florida
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania
United States	Carilion Clinic	Roanoke	Virginia
United States	Advanced Mental Health Care Inc.	Royal Palm Beach	Florida
United States	Florida Center for TMS	Saint Augustine	Florida
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	SF-Care, Inc.	San Rafael	California
United States	Psychiatric Medicine Associates, LLC	Skokie	Illinois
United States	Beacon Medical Group Behavioral Health	South Bend	Indiana
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Stedman Clinical Trials	Tampa	Florida
United States	OU-SOCM Dept of Psychiatry	Tulsa	Oklahoma
United States	Neuropsychiatric Associates, Plc	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of PHQ-8 tasks	Percentage of PHQ-8 tasks completed over the duration of the study	Through study completion; Average 2 years
Primary	Percentage of Voice Diary tasks	Percentage of Voice Diary tasks completed over the duration of the study	Through study completion; Average 2 years
Primary	Number of ping sensor recordings	Number of ping sensor recordings over the duration of the study	Through study completion; Average 2 years
Primary	Number of hours of watch wear time	Number of hours of watch wear time over the duration of the study	Through study completion; Average 2 years