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

NCT04753385 | Terminated

• 1 other identifier: LND300
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 33

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).

Conditions

Treatment Resistant Depression

Keywords

Depression; TRD

Outcome Measures

Primary Outcomes (4)

• Percentage of PHQ-8 tasks

  Percentage of PHQ-8 tasks completed over the duration of the study

  Through study completion; Average 2 years

• Percentage of Voice Diary tasks

  Percentage of Voice Diary tasks completed over the duration of the study

  Through study completion; Average 2 years

• Number of ping sensor recordings

  Number of ping sensor recordings over the duration of the study

  Through study completion; Average 2 years

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• \. Willing to comply with Study Watch wearing and recharging requirements

You may not qualify if:

• All Subjects
• Phone Application
• Study Watch
• \. Subjects with known severe allergy to nickel or metal jewelry

Sponsors & Collaborators

• LivaNova: lead

Study Sites (33)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

SF-Care, Inc.

San Rafael, California, 94901, United States

Location

Kind Research Group

Boca Raton, Florida, 33431, United States

Location

APG Research, LLC

Orlando, Florida, 32803, United States

Location

Nova Psychiatry Inc.

Orlando, Florida, 32803, United States

Location

Advanced Mental Health Care Inc.

Royal Palm Beach, Florida, 33411, United States

Location

Florida Center for TMS

Saint Augustine, Florida, 94901, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

AMR-Baber Research, Inc.

Naperville, Illinois, 60563, United States

Location

Psychiatric Medicine Associates, LLC

Skokie, Illinois, 60076, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Beacon Medical Group Behavioral Health

South Bend, Indiana, 46601, United States

Location

Sheppard Pratt Health Systems

Baltimore, Maryland, 21204, United States

Location

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, 48105, United States

Location

Psychiatric Care and Research

O'Fallon, Missouri, 633668, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Alivation Research, LLC

Lincoln, Nebraska, 68526, United States

Location

Hapworth Research Inc.

New York, New York, 10019, United States

Location

Center for Neuropsychiatry and Brain Stimulation (CNBS)

Cary, North Carolina, 27519, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

OU-SOCM Dept of Psychiatry

Tulsa, Oklahoma, 74135, United States

Location

Scranton Medical Institutes

Moosic, Pennsylvania, 18507, United States

Location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104-4283, United States

Location

UT Health Austin

Austin, Texas, 78712, United States

Location

UT Center of Excellence on Mood Disorders

Houston, Texas, 77054, United States

Location

North Pointe Psychiatry

Lewisville, Texas, 75057, United States

Location

Neuropsychiatric Associates, Plc

Woodstock, Vermont, 05091, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Seattle Neuropsychiatric Treatment Center

Bellevue, Washington, 98004, United States

Location

Center for Anxiety and Depression

Mercer Island, Washington, 98040, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Charles Conway, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: February 15, 2021
• Study Start: March 23, 2021
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (33)