The RECOVER sUb-study, Which Leverages quaNtitative and Credible Research tOols From Verily, Will providE Assessment measuRes for Depressive Episodes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
LivaNova
Study ID
NCT04753385
Status
Terminated

Conditions

  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Feb 15, 2021
Start date
Mar 23, 2021
Status verified
Dec 2024
Primary completion
Sep 6, 2024
Completion
Sep 6, 2024

Study Design

Enrollment
138 participants (actual)

Primary Outcome Measure

Percentage of PHQ-8 tasks [ Time Frame: Through study completion; Average 2 years ]

Locations (33)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
ATP Clinical Research, Inc.Costa MesaCalifornia92626-
Keck Hospital of USCLos AngelesCalifornia90033-
SF-Care, Inc.San RafaelCalifornia94901-
Kind Research GroupBoca RatonFlorida33431-
APG Research, LLCOrlandoFlorida32803-
Nova Psychiatry Inc.OrlandoFlorida32803-
Advanced Mental Health Care Inc.Royal Palm BeachFlorida33411-
Florida Center for TMSSaint AugustineFlorida94901-
Stedman Clinical TrialsTampaFlorida33613-
Augusta UniversityAugustaGeorgia30912-
AMR-Baber Research, Inc.NapervilleIllinois60563-
Psychiatric Medicine Associates, LLCSkokieIllinois60076-
Southern Illinois University School of MedicineSpringfieldIllinois62794-
Beacon Medical Group Behavioral HealthSouth BendIndiana46601-
Sheppard Pratt Health SystemsBaltimoreMaryland21204-
Michigan Clinical Research Institute PCAnn ArborMichigan48105-
Psychiatric Care and ResearchO'FallonMissouri633668-
PsychCare Consultants ResearchSt LouisMissouri63128-
Alivation Research, LLCLincolnNebraska68526-
Hapworth Research Inc.New YorkNew York10019-
Center for Neuropsychiatry and Brain Stimulation (CNBS)CaryNorth Carolina27519-
Ohio State UniversityColumbusOhio43210-
OU-SOCM Dept of PsychiatryTulsaOklahoma74135-
Scranton Medical InstitutesMoosicPennsylvania18507-
University of Pennsylvania Perelman School of MedicinePhiladelphiaPennsylvania19104-4283-
UT Health AustinAustinTexas78712-
UT Center of Excellence on Mood DisordersHoustonTexas77054-
North Pointe PsychiatryLewisvilleTexas75057-
Neuropsychiatric Associates, PlcWoodstockVermont05091-
Carilion ClinicRoanokeVirginia24014-
Seattle Neuropsychiatric Treatment CenterBellevueWashington98004-
Center for Anxiety and DepressionMercer IslandWashington98040-

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