The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes
Stopped early
Conditions studied: Treatment Resistant Depression
In brief
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).
Key facts
- Study ID
- NCT04753385
- Run by
- LivaNova
- People needed
- 138
- Starts
- 2021-03-23
- Expected to finish
- 2024-09-06
- Last updated by the study team
- 2024-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- ATP Clinical Research, Inc. — Costa Mesa, California, United States
- Keck Hospital of USC — Los Angeles, California, United States
- SF-Care, Inc. — San Rafael, California, United States
- Kind Research Group — Boca Raton, Florida, United States
- APG Research, LLC — Orlando, Florida, United States
- Nova Psychiatry Inc. — Orlando, Florida, United States
- Advanced Mental Health Care Inc. — Royal Palm Beach, Florida, United States
- Florida Center for TMS — Saint Augustine, Florida, United States
- Stedman Clinical Trials — Tampa, Florida, United States
- Augusta University — Augusta, Georgia, United States
- AMR-Baber Research, Inc. — Naperville, Illinois, United States
- Psychiatric Medicine Associates, LLC — Skokie, Illinois, United States
- Southern Illinois University School of Medicine — Springfield, Illinois, United States
- Beacon Medical Group Behavioral Health — South Bend, Indiana, United States
- Sheppard Pratt Health Systems — Baltimore, Maryland, United States
- Michigan Clinical Research Institute PC — Ann Arbor, Michigan, United States
- Psychiatric Care and Research — O'Fallon, Missouri, United States
- PsychCare Consultants Research — St Louis, Missouri, United States
- Alivation Research, LLC — Lincoln, Nebraska, United States
- Hapworth Research Inc. — New York, New York, United States
- Center for Neuropsychiatry and Brain Stimulation (CNBS) — Cary, North Carolina, United States
- Ohio State University — Columbus, Ohio, United States
- OU-SOCM Dept of Psychiatry — Tulsa, Oklahoma, United States
- Scranton Medical Institutes — Moosic, Pennsylvania, United States
Full record on ClinicalTrials.gov
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