Treatment Resistant DepressionUNCOVERNCT04753385
The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
An observational study of Treatment Resistant Depression, run by LivaNova at 33 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression
- How many people
- 138 participants
- Where
- 33 sitesUnited States
- Study dates
- 23 Mar 2021to 6 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, 48105
Augusta University
Augusta, Georgia, 30912
UT Health Austin
Austin, Texas, 78712
Sheppard Pratt Health Systems
Baltimore, Maryland, 21204
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, 98004
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Kind Research Group
Boca Raton, Florida, 33431
Center for Neuropsychiatry and Brain Stimulation (CNBS)
Cary, North Carolina, 27519
Ohio State University
Columbus, Ohio, 43210
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
UT Center of Excellence on Mood Disorders
Houston, Texas, 77054
North Pointe Psychiatry
Lewisville, Texas, 75057
Alivation Research, LLC
Lincoln, Nebraska, 68526
Keck Hospital of USC
Los Angeles, California, 90033
Center for Anxiety and Depression
Mercer Island, Washington, 98040
Scranton Medical Institutes
Moosic, Pennsylvania, 18507
AMR-Baber Research, Inc.
Naperville, Illinois, 60563
Hapworth Research Inc.
New York, New York, 10019
Psychiatric Care and Research
O'Fallon, Missouri, 633668
APG Research, LLC
Orlando, Florida, 32803
Nova Psychiatry Inc.
Orlando, Florida, 32803
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104-4283
Carilion Clinic
Roanoke, Virginia, 24014
Advanced Mental Health Care Inc.
Royal Palm Beach, Florida, 33411
Florida Center for TMS
Saint Augustine, Florida, 94901
SF-Care, Inc.
San Rafael, California, 94901
Psychiatric Medicine Associates, LLC
Skokie, Illinois, 60076
Beacon Medical Group Behavioral Health
South Bend, Indiana, 46601
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
PsychCare Consultants Research
St Louis, Missouri, 63128
Stedman Clinical Trials
Tampa, Florida, 33613
OU-SOCM Dept of Psychiatry
Tulsa, Oklahoma, 74135
Neuropsychiatric Associates, Plc
Woodstock, Vermont, 05091
About this study
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).
Read the 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.
- Conditions
- Treatment Resistant Depression
- Keywords
- Depression, TRD
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of PHQ-8 tasks
Percentage of PHQ-8 tasks completed over the duration of the study
Measured: Through study completion; Average 2 years
Percentage of Voice Diary tasks
Percentage of Voice Diary tasks completed over the duration of the study
Measured: Through study completion; Average 2 years
Number of ping sensor recordings
Number of ping sensor recordings over the duration of the study
Measured: 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
Measured: Through study completion; Average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start23 Mar 2021
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Why it stopped: UNCOVER terminated early based on low enrollment and lack of device data collected making analysis unfeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Conway, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753385
- Sponsor's protocol ID
- LND300
- Acronym
- UNCOVER
- Status last verified
- Dec 2024
- First submitted
- 7 Jan 2021
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
- ClinicalTrials.gov ID
- NCT04753385
- Acronym / sponsor ID
- UNCOVER / LND300
- Conditions
- Treatment Resistant Depression
- Keywords
- Depression, TRD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: UNCOVER terminated early based on low enrollment and lack of device data collected making analysis unfeasible.
- Enrolment
- 138 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Number of ping sensor recordings
Time frame: Through study completion; Average 2 years
Number of ping sensor recordings over the duration of the study
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
Results and safety
The study was stopped early (reason given: UNCOVER terminated early based on low enrollment and lack of device data collected making analysis unfeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Conway, MD principal investigator
Washington University School of Medicine
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Resistant Depression, run by LivaNova at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: UNCOVER terminated early based on low enrollment and lack of device data collected making analysis unfeasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of PHQ-8 tasks (time frame: Through study completion; Average 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.