Clinical trial NCT04753385: The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
Official title: The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Treatment Resistant Depression
Keywords: Depression
TRD
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of PHQ-8 tasks
timeFrame: Through study completion; Average 2 years
measure: Percentage of Voice Diary tasks
timeFrame: Through study completion; Average 2 years
measure: Number of ping sensor recordings
timeFrame: Through study completion; Average 2 years
measure: Number of hours of watch wear time
timeFrame: Through study completion; Average 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: San Rafael
country: United States
facility: SF-Care, Inc.
state: California
city: Boca Raton
country: United States
facility: Kind Research Group
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC
state: Florida
city: Orlando
country: United States
facility: Nova Psychiatry Inc.
state: Florida
city: Royal Palm Beach
country: United States
facility: Advanced Mental Health Care Inc.
state: Florida
city: Saint Augustine
country: United States
facility: Florida Center for TMS
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Naperville
country: United States
facility: AMR-Baber Research, Inc.
state: Illinois
city: Skokie
country: United States
facility: Psychiatric Medicine Associates, LLC
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: South Bend
country: United States
facility: Beacon Medical Group Behavioral Health
state: Indiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health Systems
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute PC
state: Michigan
city: O'Fallon
country: United States
facility: Psychiatric Care and Research
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: New York
country: United States
facility: Hapworth Research Inc.
state: New York
city: Cary
country: United States
facility: Center for Neuropsychiatry and Brain Stimulation (CNBS)
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Tulsa
country: United States
facility: OU-SOCM Dept of Psychiatry
state: Oklahoma
city: Moosic
country: United States
facility: Scranton Medical Institutes
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
city: Austin
country: United States
facility: UT Health Austin
state: Texas
city: Houston
country: United States
facility: UT Center of Excellence on Mood Disorders
state: Texas
city: Lewisville
country: United States
facility: North Pointe Psychiatry
state: Texas
city: Woodstock
country: United States
facility: Neuropsychiatric Associates, Plc
state: Vermont
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Bellevue
country: United States
facility: Seattle Neuropsychiatric Treatment Center
state: Washington
city: Mercer Island
country: United States
facility: Center for Anxiety and Depression
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Charles Conway, MD
role: PRINCIPAL_INVESTIGATOR
References: