NCT04753385Terminated
The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
Source: ClinicalTrials.gov · Last updated 20 Dec 2024
Reason given: UNCOVER terminated early based on low enrollment and lack of device data collected making analysis unfeasible.
Brief summary (registry, in English)
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).
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 138 (actual)
- First submitted
- 7 Jan 2021
- Start date
- 23 Mar 2021
- Primary completion date
- 6 Sept 2024
- Lead sponsor
- LivaNova
- Diseases
- Depression
- NCT number
- NCT04753385
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition or situation the Principal Investigator determines as inappropriate for study inclusion
- Phone Application
- No additional exclusion criteria for phone application
- Study Watch
- Subjects with known severe allergy to nickel or metal jewelry
Other
- All Subjects
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michigan Clinical Research Institute PC | Ann Arbor | United States | Unknown status |
| Augusta University | Augusta | United States | Unknown status |
| UT Health Austin | Austin | United States | Unknown status |
| Sheppard Pratt Health Systems | Baltimore | United States | Unknown status |
| Seattle Neuropsychiatric Treatment Center | Bellevue | United States | Unknown status |
| University of Alabama at Birmingham | Birmingham | United States | Unknown status |
| Kind Research Group | Boca Raton | United States | Unknown status |
| Center for Neuropsychiatry and Brain Stimulation (CNBS) | Cary | United States | Unknown status |
| Ohio State University | Columbus | United States | Unknown status |
| ATP Clinical Research, Inc. | Costa Mesa | United States | Unknown status |
| UT Center of Excellence on Mood Disorders | Houston | United States | Unknown status |
| North Pointe Psychiatry | Lewisville | United States | Unknown status |
| Alivation Research, LLC | Lincoln | United States | Unknown status |
| Keck Hospital of USC | Los Angeles | United States | Unknown status |
| Center For Anxiety and Depression | Mercer Island | United States | Unknown status |
| Scranton Medical Institutes | Moosic | United States | Unknown status |
| AMR-Baber Research Inc | Naperville | United States | Unknown status |
| Hapworth Research Inc. | New York | United States | Unknown status |
| Psychiatric Care and Research | O'Fallon | United States | Unknown status |
| APG Research, LLC | Orlando | United States | Unknown status |
| Nova Psychiatry Inc. | Orlando | United States | Unknown status |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | United States | Unknown status |
| Carilion Clinic | Roanoke | United States | Unknown status |
| Advanced Mental Health Care Inc. | Royal Palm Beach | United States | Unknown status |
| Florida Center for TMS | Saint Augustine | United States | Unknown status |
| SF-CARE, Inc. | San Rafael | United States | Unknown status |
| Psychiatric Medicine Associates, LLC | Skokie | United States | Unknown status |
| Beacon Medical Group Behavioral Health | South Bend | United States | Unknown status |
| Southern Illinois University School of Medicine | Springfield | United States | Unknown status |
| PsychCare Consultants Research | St Louis | United States | Unknown status |
| Stedman Clinical Trials | Tampa | United States | Unknown status |
| OU-SOCM Dept of Psychiatry | Tulsa | United States | Unknown status |
| Neuropsychiatric Associates, Plc | Woodstock | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.