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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

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Michigan Clinical Research Institute PCAnn ArborUnited StatesUnknown status
Augusta UniversityAugustaUnited StatesUnknown status
UT Health AustinAustinUnited StatesUnknown status
Sheppard Pratt Health SystemsBaltimoreUnited StatesUnknown status
Seattle Neuropsychiatric Treatment CenterBellevueUnited StatesUnknown status
University of Alabama at BirminghamBirminghamUnited StatesUnknown status
Kind Research GroupBoca RatonUnited StatesUnknown status
Center for Neuropsychiatry and Brain Stimulation (CNBS)CaryUnited StatesUnknown status
Ohio State UniversityColumbusUnited StatesUnknown status
ATP Clinical Research, Inc.Costa MesaUnited StatesUnknown status
UT Center of Excellence on Mood DisordersHoustonUnited StatesUnknown status
North Pointe PsychiatryLewisvilleUnited StatesUnknown status
Alivation Research, LLCLincolnUnited StatesUnknown status
Keck Hospital of USCLos AngelesUnited StatesUnknown status
Center For Anxiety and DepressionMercer IslandUnited StatesUnknown status
Scranton Medical InstitutesMoosicUnited StatesUnknown status
AMR-Baber Research IncNapervilleUnited StatesUnknown status
Hapworth Research Inc.New YorkUnited StatesUnknown status
Psychiatric Care and ResearchO'FallonUnited StatesUnknown status
APG Research, LLCOrlandoUnited StatesUnknown status
Nova Psychiatry Inc.OrlandoUnited StatesUnknown status
University of Pennsylvania Perelman School of MedicinePhiladelphiaUnited StatesUnknown status
Carilion ClinicRoanokeUnited StatesUnknown status
Advanced Mental Health Care Inc.Royal Palm BeachUnited StatesUnknown status
Florida Center for TMSSaint AugustineUnited StatesUnknown status
SF-CARE, Inc.San RafaelUnited StatesUnknown status
Psychiatric Medicine Associates, LLCSkokieUnited StatesUnknown status
Beacon Medical Group Behavioral HealthSouth BendUnited StatesUnknown status
Southern Illinois University School of MedicineSpringfieldUnited StatesUnknown status
PsychCare Consultants ResearchSt LouisUnited StatesUnknown status
Stedman Clinical TrialsTampaUnited StatesUnknown status
OU-SOCM Dept of PsychiatryTulsaUnited StatesUnknown status
Neuropsychiatric Associates, PlcWoodstockUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.