Back to resultsA 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 (RECOVER)
Primary Purpose
Treatment Resistant Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vagus Nerve Stimulation (VNS)
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression focused on measuring VNS, Depression, TRD
Eligibility Criteria
Inclusion Criteria:
The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.
The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.
The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.
Patients must maintain a stable medication regimen for at least four weeks before device implantation.
Exclusion Criteria:
Current or lifetime history of psychotic features in any MDE;
Current or lifetime history of schizophrenia or schizoaffective disorder;
Current or lifetime history of any other psychotic disorder;
Current or lifetime history of rapid cycling bipolar disorder;
Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;
Current suicidal intent; or
Treatment with another investigational device or investigational drugs.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- UAB Huntsville Regional Medical CenterRecruiting
- Access Multi Specialty Medical Clinic, Inc
- CMB Clinical Trials
- ATP Clinical Research, Inc.Recruiting
- Kaizen Brain CenterRecruiting
- Keck Hospital of USCRecruiting
- University of California San Diego
- SF-CARE, Inc.Recruiting
- Syrentis Clinical Research
- Sunrise Research Institute
- Mindful Behavioral HealthRecruiting
- Medycal Research, Inc
- Galiz Research LLCRecruiting
- Florida Behavioral PsychRecruiting
- Segal Trials Corporate
- Ocean Blue Medical Research Center
- Central Miami Medical Institute, LLC
- Clintex Research Group, Inc.
- Research Center Of Florida, Inc
- APG Research, LLCRecruiting
- Nova Psychiatry Inc.Recruiting
- Florida Center for TMSRecruiting
- Millenia Psychiatry & Research, Inc
- Quantum Laboratories Inc.
- Advanced Mental Health Care Inc.Recruiting
- Florida Center for TMSRecruiting
- Stedman Clinical TrialsRecruiting
- Psychiatric Specialty Center
- Emory UniversityRecruiting
- Medical College of Georgia, Augusta UniversityRecruiting
- PACT Atlanta LLC
- IACT Health
- Psych AtlantaRecruiting
- Pearl Health Clinic
- Rush University Medical CenterRecruiting
- Joliet Center For Clinical Research
- AMR- Baber Research, Inc.Recruiting
- Psychiatric Medicine Associates, LLCRecruiting
- Southern Illinois University School of MedicineRecruiting
- Neuroscience Research Institute
- Advanced Research Institute, Inc.
- Beacon Medical Group Behavioral HealthRecruiting
- University Of Kansas Cancer CenterRecruiting
- Sheppard Pratt Health System, Inc.Recruiting
- Clinical Insights
- Massachusetts General HospitalRecruiting
- Michigan Clinical Research Institute PC
- University of MinnesotaRecruiting
- Precise Research CentersRecruiting
- Andrew Bishop, MDRecruiting
- University of MissouriRecruiting
- Psychiatric Care and ResearchRecruiting
- Barnes-Jewish HospitalRecruiting
- PsychCare Consultants ResearchRecruiting
- Alivation Research, LLCRecruiting
- Healthy PerspectiveRecruiting
- Jersey Shore University Medical Center
- University of New Mexico - Psychiatric Center
- Dent Neurological InstituteRecruiting
- Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
- Trinity MedicalRecruiting
- Hapworth Research Inc.Recruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Richmond Behavioral Associates
- Stony Brook University HospitalRecruiting
- State University Of New York Upstate Medical UniversityRecruiting
- The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC HealthRecruiting
- Mindpath Care Centers
- Wake Forest University Health Science
- University Hospitals Case Medical Center
- The Ohio State UniversityRecruiting
- Signature Research Associates, Inc.Recruiting
- Charak Center for Health and WellnessRecruiting
- NPC Research
- Rivus Wellness & Research Institute
- University of Oklahoma School of Community MedicineRecruiting
- Scranton Medical InstitutesRecruiting
- University of PennsylvaniaRecruiting
- Medical University of South CarolinaRecruiting
- Neuroscience and TMS Treatment CenterRecruiting
- UT Health Austin, Mulva Clinic for the NeurosciencesRecruiting
- BioBehavioral Research of AustinRecruiting
- University of Texas SouthwesternRecruiting
- Texas Tech University Health Science CenterRecruiting
- The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood DisordersRecruiting
- Houston Clinical Trials
- Northpointe PsychiatryRecruiting
- Rise Clinical Research, LLC
- The University of UtahRecruiting
- Neuropsychiatric Associates, PlcRecruiting
- Carilion ClinicRecruiting
- Center For Anxiety and DepressionRecruiting
- Seattle Neuropsychiatric Treatment CenterRecruiting
- Marshall University Joan C. Edwards School of MedicineRecruiting
- West Virginia Clinical and Translational Science Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active
Control
Arm Description
Group will have VNS activated 2 weeks post implant.
Group will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Outcomes
Primary Outcome Measures
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response
The rate of response defined as person months of response/total months of study participation where response is at least a 50% reduction from baseline in MADRS total score. Subjects discontinuing the study before the endpoint assessment will be considered as non-responders for each successive month after discontinuance.
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response
Time from randomization to the first observed MADRS response.
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission
Time from randomization to the first observed MADRS remission.
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response
Duration of MADRS response, defined as the number of consecutive months from first observed MADRS response to the first assessment of MADRS response relapse.
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission
The rate of remission is defined as total number of months in remission divided by total months of expected study participation. Subjects discontinuing the study before the endpoint assessment will be considered as non-in-remission for each successive month after discontinuance
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response
Maximum duration of MADRS response, defined as the maximum number of consecutive months in response (only for subjects experiencing MADRS response).
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission
Duration of MADRS remission, defined as the number of consecutive months from first observed MADRS remission to the first assessment of MADRS remission relapse (defined score > 20).
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission
Maximum duration of MADRS remission, defined as the maximum number of consecutive months in remission (only for subjects experiencing MADRS remission).
Assess all Adverse Events
All adverse events, with a focus on device or procedure-related serious adverse events.
WHO Disability Assessment Schedule (WHODAS) Changes in scores over time
Health Outcome Scale (EQ-5D-L) Changes in scores over time
Clinical Global Impressions Scale - Improvement (CGI-I) Response
A CGI-I score ≤ 2 at 12 months from randomization. Subjects discontinuing the study before the 12 months assessment will be considered as not in response for each successive month after discontinuance.
Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality
Suicide attempts as measured by items #10 & #12 in S-STS scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03887715
Brief Title
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
Acronym
RECOVER
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
February 28, 2028 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.
Detailed Description
A prospective, multi-center, randomized, controlled, blinded trial of subjects implanted with VNS Therapy. Active treatment and no stimulation control are randomized, at least two weeks after implantation and observed for 12-months.
After completing the 12 month endpoint in the RCT portion of the study, all RECOVER subjects will transition into the prospective, open-label, longitudinal portion of the study. Subjects in the control arm of RECOVER will be activated after completing the 12 month endpoint.
After completion of enrollment in the RCT portion or meeting of interim success criterion (whichever comes first), up to 5,800 new subjects may enroll directly into the open-label,prospective, longitudinal study. These subjects will participate in the study for approximately 5 years.
The study has been designed in accordance with The Centers for Medicare and Medicaid Services coverage with evidence development (CED) decision entitled "Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
VNS, Depression, TRD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization of active stimulation vs. no stimulation for 12 months post randomization.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Central Rater and sponsor are blinded in the RCT phase. Sites will need to have an unblinded programmer who is only programming the device and not collecting outcomes data.
Allocation
Randomized
Enrollment
6800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Group will have VNS activated 2 weeks post implant.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Group will be implanted with VNS but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation (VNS)
Other Intervention Name(s)
VNS
Intervention Description
VNS is an implantable device that delivers stimulation to the vagal nerve.
Primary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response
Description
The rate of response defined as person months of response/total months of study participation where response is at least a 50% reduction from baseline in MADRS total score. Subjects discontinuing the study before the endpoint assessment will be considered as non-responders for each successive month after discontinuance.
Time Frame
12 months post randomization
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response
Description
Time from randomization to the first observed MADRS response.
Time Frame
Baseline up to 12 Months
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission
Description
Time from randomization to the first observed MADRS remission.
Time Frame
Baseline up to 12 Months
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Response
Description
Duration of MADRS response, defined as the number of consecutive months from first observed MADRS response to the first assessment of MADRS response relapse.
Time Frame
Baseline up to 12 Months
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Remission
Description
The rate of remission is defined as total number of months in remission divided by total months of expected study participation. Subjects discontinuing the study before the endpoint assessment will be considered as non-in-remission for each successive month after discontinuance
Time Frame
Baseline up to 12 Months
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Response
Description
Maximum duration of MADRS response, defined as the maximum number of consecutive months in response (only for subjects experiencing MADRS response).
Time Frame
Baseline up to 12 Months
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Duration of Remission
Description
Duration of MADRS remission, defined as the number of consecutive months from first observed MADRS remission to the first assessment of MADRS remission relapse (defined score > 20).
Time Frame
Baseline up to 12 Months
Title
Montgomery Åsberg Depression Rating Scale (MADRS) Maximum duration of Remission
Description
Maximum duration of MADRS remission, defined as the maximum number of consecutive months in remission (only for subjects experiencing MADRS remission).
Time Frame
Baseline up to 12 Months
Title
Assess all Adverse Events
Description
All adverse events, with a focus on device or procedure-related serious adverse events.
Time Frame
Implant to 12 Months
Title
WHO Disability Assessment Schedule (WHODAS) Changes in scores over time
Time Frame
Baseline to 12 Months
Title
Health Outcome Scale (EQ-5D-L) Changes in scores over time
Time Frame
Baseline to 12 Months
Title
Clinical Global Impressions Scale - Improvement (CGI-I) Response
Description
A CGI-I score ≤ 2 at 12 months from randomization. Subjects discontinuing the study before the 12 months assessment will be considered as not in response for each successive month after discontinuance.
Time Frame
12 months post randomization
Title
Sheehan Suicidality Tracking Scale (S-STS) Changes in Suicidality
Description
Suicide attempts as measured by items #10 & #12 in S-STS scale
Time Frame
Implant to 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode.
The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.
The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.
Patients must maintain a stable medication regimen for at least four weeks before device implantation.
Exclusion Criteria:
Current or lifetime history of psychotic features in any MDE;
Current or lifetime history of schizophrenia or schizoaffective disorder;
Current or lifetime history of any other psychotic disorder;
Current or lifetime history of rapid cycling bipolar disorder;
Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;
Current suicidal intent; or
Treatment with another investigational device or investigational drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Yates, BSN
Phone
281-228-7200
Email
laura.yates@livanova.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Way, BS
Phone
281-228-7200
Email
jeffrey.way@livanova.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Conway, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candace Green
Phone
205-976-0068
Email
candacegreen@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Matthew Macaluso, DO
Facility Name
UAB Huntsville Regional Medical Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Howell
Phone
256-551-4431
Email
hsvpsychresearch@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Richard Shelton
Facility Name
Access Multi Specialty Medical Clinic, Inc
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Individual Site Status
Terminated
Facility Name
CMB Clinical Trials
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Individual Site Status
Withdrawn
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobby Shih
Phone
714-277-4472
Email
bshih@atpcr.com
First Name & Middle Initial & Last Name & Degree
Gustavo Alva, MD
Facility Name
Kaizen Brain Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Escamirosa
Phone
866-277-2659
Email
melissa@kaizenbraincenter.com
First Name & Middle Initial & Last Name & Degree
Mohammed Ahmed, MD
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Durkin
Phone
213-631-8487
Email
zoe.durkin@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Ashraf Elmashat, MD
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SF-CARE, Inc.
City
San Rafael
State/Province
California
ZIP/Postal Code
94901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seema Bangalore
Phone
415-747-8474
Email
seema@sf-care.com
First Name & Middle Initial & Last Name & Degree
Jason Bermak, MD
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sunrise Research Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33325
Country
United States
Individual Site Status
Terminated
Facility Name
Mindful Behavioral Health
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Stepler
Phone
561-499-6933
Email
astepler@gminstitutes.com
First Name & Middle Initial & Last Name & Degree
Ivan Cichowicz, MD
Facility Name
Medycal Research, Inc
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Individual Site Status
Terminated
Facility Name
Galiz Research LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohana Lima
Phone
305-805-0921
Email
yohana@galizresearch.com
First Name & Middle Initial & Last Name & Degree
Jose Gamez, MD
Facility Name
Florida Behavioral Psych
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Bussey
Phone
727-510-9773
Email
cbussey@vantagetrials.com
First Name & Middle Initial & Last Name & Degree
Ashok Patel, MD
Facility Name
Segal Trials Corporate
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ocean Blue Medical Research Center
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Withdrawn
Facility Name
Central Miami Medical Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clintex Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Terminated
Facility Name
Research Center Of Florida, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Withdrawn
Facility Name
APG Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kailee Kenworthy
Phone
407-808-1875
Email
kkenworthyapg@gmail.com
First Name & Middle Initial & Last Name & Degree
Morteza Nadjafi, MD
Facility Name
Nova Psychiatry Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Torres
Phone
401-883-9303
Email
novapsychiatryinc@gmail.com
First Name & Middle Initial & Last Name & Degree
David Medina, MD
Facility Name
Florida Center for TMS
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Fritz
Phone
833-651-1990
Email
contact@floridacenterfortms.com
First Name & Middle Initial & Last Name & Degree
Todd Broder, MD
Facility Name
Millenia Psychiatry & Research, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Withdrawn
Facility Name
Quantum Laboratories Inc.
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Terminated
Facility Name
Advanced Mental Health Care Inc.
City
Royal Palm Beach
State/Province
Florida
ZIP/Postal Code
33411
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyssa Sisko
Phone
561-333-8884
Email
Amhc.phones@gmail.com
First Name & Middle Initial & Last Name & Degree
Aron Tendler, MD
Facility Name
Florida Center for TMS
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
94901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason R Fritz
Phone
850-212-6262
Email
jfritz01@gmail.com
First Name & Middle Initial & Last Name & Degree
Heather Luing, MD
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Fowler
Phone
813-971-8311
Email
susan_fowler@stedmanclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Mary L Stedman, MD
Facility Name
Psychiatric Specialty Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Individual Site Status
Terminated
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinéad Quinn
Phone
404-727-9228
Email
scquinn@emory.edu
First Name & Middle Initial & Last Name & Degree
Patricio Riva Posse, MD
Facility Name
Medical College of Georgia, Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laryssa McCloud
Phone
706-721-7968
Email
lmccloud@augusta.edu
First Name & Middle Initial & Last Name & Degree
Peter Rosenquist, MD
Facility Name
PACT Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Terminated
Facility Name
IACT Health
City
Grayson
State/Province
Georgia
ZIP/Postal Code
30017
Country
United States
Individual Site Status
Withdrawn
Facility Name
Psych Atlanta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Kane
Phone
770-422-2846
Email
jenniferk@nbmedicine.com
First Name & Middle Initial & Last Name & Degree
Michael Banov, MD
Facility Name
Pearl Health Clinic
City
Ammon
State/Province
Idaho
ZIP/Postal Code
83406
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Skaggs
Phone
312-942-6597
Email
linda_skaggs@rush.edu
First Name & Middle Initial & Last Name & Degree
John Zajecka
Facility Name
Joliet Center For Clinical Research
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Individual Site Status
Terminated
Facility Name
AMR- Baber Research, Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freeda Baber
Phone
630-272-4844
Email
freeda@baberresearchgroup.com
First Name & Middle Initial & Last Name & Degree
Riaz Baber, MD
Facility Name
Psychiatric Medicine Associates, LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda White
Phone
847-679-8000
Ext
12
Email
awhite.pma@gmail.com
First Name & Middle Initial & Last Name & Degree
John Zajecka, MD
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oladele Owasoyo, PhD
Phone
217-545-7321
Email
Oowasoyo94@siumed.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Bennett, MD
Facility Name
Neuroscience Research Institute
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60910
Country
United States
Individual Site Status
Withdrawn
Facility Name
Advanced Research Institute, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
56268
Country
United States
Individual Site Status
Terminated
Facility Name
Beacon Medical Group Behavioral Health
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa DePue, RN
Phone
574-647-6584
Email
Vdepue@beaconhealthsystem.org
First Name & Middle Initial & Last Name & Degree
Suhayl Nasr, MD
Facility Name
University Of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christa Wessel
Phone
913-588-1300
Email
cwessel@kumc.edu
First Name & Middle Initial & Last Name & Degree
Tyler Kjorvestad, MD
Facility Name
Sheppard Pratt Health System, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryce Lund
Phone
410-938-3126
Email
Bryce.lund1@sheppardpratt.org
First Name & Middle Initial & Last Name & Degree
Scott Aaronson, MD
Facility Name
Clinical Insights
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Individual Site Status
Withdrawn
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doga Cetinkaya
Phone
617-726-2938
Email
dcetinkaya@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Isabella Henneman
Phone
617-724-2322
Email
ihenneman@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Cristina Cusin, MD
Facility Name
Michigan Clinical Research Institute PC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Shah Din
Phone
952-525-4505
Email
ipl@umn.edu
First Name & Middle Initial & Last Name & Degree
Ziad Nahas, MD
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Fickert
Phone
601-420-5810
Email
kfickert@precise-research.com
First Name & Middle Initial & Last Name & Degree
Joseph Kwentus, MD
Facility Name
Andrew Bishop, MD
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Dougay
Phone
601-981-1010
Ext
16
Email
haleydougay@gmail.com
First Name & Middle Initial & Last Name & Degree
Andrew Bishop, MD
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Schmidt
Phone
573-882-5688
Email
schmidtmw@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Muaid Ithman, MD
Facility Name
Psychiatric Care and Research
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
633668
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Beth Haug
Phone
636-244-3593
Email
mhaug@pcrc-stl.com
First Name & Middle Initial & Last Name & Degree
John Canale, MD
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Brouk
Phone
314-362-5113
Email
abrouk@wustl.edu
First Name & Middle Initial & Last Name & Degree
Donald Bohnenkamp, MD
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Broeker
Phone
314-849-1853
Ext
203
Email
anita.broeker@pccresearch.org
First Name & Middle Initial & Last Name & Degree
Mohd Malik, MD
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Espenschade
Phone
402-817-2235
Email
KEspenschade@alivation.com
First Name & Middle Initial & Last Name & Degree
Walter Duffy, MD
Facility Name
Healthy Perspective
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Gilbert, APRN
Phone
603-880-9880
Email
ngilbert@hp-imhs.com
First Name & Middle Initial & Last Name & Degree
Hisham Hafez, MD
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of New Mexico - Psychiatric Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Withdrawn
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Rainka, PharmD
Phone
716-250-2038
Email
mrainka@dentinstitute.com
First Name & Middle Initial & Last Name & Degree
Horacio Capote, MD
Facility Name
Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Trinity Medical
City
Lewiston
State/Province
New York
ZIP/Postal Code
14092
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Jimenez-Knight
Phone
716-862-2426
Email
tjimenezknight@chsbuffalo.org
First Name & Middle Initial & Last Name & Degree
Alfred Belen, MD
Facility Name
Hapworth Research Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariah Garcia
Phone
212-956-2000
Email
mgarcia@treatmentonline.com
First Name & Middle Initial & Last Name & Degree
William Hapworth, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Meyer, MD
Phone
212-585-4640
Email
emma.meyer@mssm.edu
First Name & Middle Initial & Last Name & Degree
James M Murrough, MD
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan M. Fiore
Phone
631-444-9425
Email
Susan.Fiore@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Lucian Manu, MD
Facility Name
State University Of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schwartz (PI), MD
Phone
315-464-3166
Email
schwartt@upstate.edu
Facility Name
The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vania Wadlington
Phone
919-728-1954
Ext
3002
Email
Vania.Wadlington@centerforbrainstim.com
First Name & Middle Initial & Last Name & Degree
Sandeep Vaishnavi
Facility Name
Mindpath Care Centers
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27606
Country
United States
Individual Site Status
Terminated
Facility Name
Wake Forest University Health Science
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Duchemin
Phone
614-293-5517
Email
anne-marie.duchemin@osumc.edu
First Name & Middle Initial & Last Name & Degree
Kevin Reeves, MD
Facility Name
Signature Research Associates, Inc.
City
Fairlawn
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Faust
Phone
330-835-4000
Email
faust.carl@yahoo.com
First Name & Middle Initial & Last Name & Degree
Anand Chaturvedi
Facility Name
Charak Center for Health and Wellness
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenzie Miller
Phone
216-280-6374
Email
kmiller@charakcenter.com
First Name & Middle Initial & Last Name & Degree
Rakesh Ranjan, MD
Facility Name
NPC Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109-3834
Country
United States
Individual Site Status
Withdrawn
Facility Name
Rivus Wellness & Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Terminated
Facility Name
University of Oklahoma School of Community Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Matukewicz, MHR
Phone
918-660-3118
Email
Michelle-matukewicz@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Ondria Gleason, MD
Facility Name
Scranton Medical Institutes
City
Moosic
State/Province
Pennsylvania
ZIP/Postal Code
18507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Terranella
Phone
570-346-3686
Ext
172
Email
sterranella@gminstitutes.com
First Name & Middle Initial & Last Name & Degree
Zoha Babar
Phone
570-346-3686
Ext
311
Email
zbabar@gminstitutes.com
First Name & Middle Initial & Last Name & Degree
Matthew Berger, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessia Seroff
Phone
215-746-3513
Email
alessia.seroff@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Yvett Sheline, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgan Dancy
Phone
843-876-5141
Email
maddoxm@musc.edu
First Name & Middle Initial & Last Name & Degree
Mark George, MD
Facility Name
Neuroscience and TMS Treatment Center
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Raines Guidry
Phone
615-973-9243
Email
anna.guidry@hopeforyourbrain.com
First Name & Middle Initial & Last Name & Degree
Jonathan Becker, MD
Facility Name
UT Health Austin, Mulva Clinic for the Neurosciences
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Bernal
Phone
833-882-2737
Email
nicole.bernal@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Julie Farmington, MD
Facility Name
BioBehavioral Research of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Vasquez
Phone
512-382-6661
Email
michael.vasquez@qcromaha.com
First Name & Middle Initial & Last Name & Degree
Charles Sweet, MD
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hila Abush Segev, PhD
Phone
214-648-0401
Email
Hila.abushsegev@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Kala Bailey, MD
Facility Name
Texas Tech University Health Science Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Thompson (PI), MD
Phone
915-215-5850
Email
pm.thompson@ttuhsc.edu
Facility Name
The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bashar Asir, MD
Phone
713-486-2567
Email
Bashar.l.asir@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Joao De Quevedo, MD, PhD
Facility Name
Houston Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Terminated
Facility Name
Northpointe Psychiatry
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asad Islam (PI), MD
Phone
214-799-8277
Email
northpointe.research@gmail.com
Facility Name
Rise Clinical Research, LLC
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Individual Site Status
Terminated
Facility Name
The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Mickey (PI), MD, PhD
Phone
801-587-3297
First Name & Middle Initial & Last Name & Degree
Sarah Kwon
Phone
(801) 829-7382
Email
sarah.kwon@hsc.utah.edu
Facility Name
Neuropsychiatric Associates, Plc
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Balenger
Phone
802-457-4904
Email
bbalenger@woodstockresearch.org
First Name & Middle Initial & Last Name & Degree
Susan Smiga, MD
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryce Lewis
Phone
540-494-8285
Email
brlewis@carilionclinic.org
First Name & Middle Initial & Last Name & Degree
Anita Kablinger, MD
Facility Name
Center For Anxiety and Depression
City
Mercer Island
State/Province
Washington
ZIP/Postal Code
98040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David L Dunner (PI), MD
Phone
206-230-0330
Email
dldunner@comcast.net
Facility Name
Seattle Neuropsychiatric Treatment Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libby Kell
Phone
206-467-6300
Email
research@seattlentc.com
First Name & Middle Initial & Last Name & Degree
Rebecca Allen, MD
Facility Name
Marshall University Joan C. Edwards School of Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Holroyd, MD
Phone
304-691-1836
Email
holroyds@marshall.edu
First Name & Middle Initial & Last Name & Degree
Suzanne Holroyd, MD
Facility Name
West Virginia Clinical and Translational Science Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=292
Description
CMS Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression
Learn more about this 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
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