Prognostic and Prescriptive Predictors of Treatment Response to Adjunctive VNS Therapy in Major Depressive Disorder: A RECOVER Trial Report.
Scott T Aaronson, Charles R Conway, Charles Gordon...
https://pubmed.ncbi.nlm.nih.gov/40673907Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03887715
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy4 System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Led by LivaNova · Updated on 2026-01-26
6800
Participants Needed
98
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment for people with treatment-resistant depression. The study aims to find out if active VNS therapy can reduce the severity of depression symptoms compared to no stimulation over a 12-month period. This is a randomized, controlled, and blinded trial involving subjects implanted with the VNS device. Participants are randomly assigned to one of two groups: one group will have the VNS device activated two weeks after implantation, while the other group will have the device implanted but not activated for the first 12 months. After 12 months, those in the control group may receive stimulation. After completing the 12-month randomized portion, all subjects can join an open-label, longer-term study lasting about 5 years to continue monitoring. During the study, participants will undergo assessments using several depression rating scales at regular intervals, including the Montgomery Åsberg Depression Rating Scale (MADRS), with evaluation of response, remission, and duration of effects. Additional measures include assessments of disability, health outcomes, clinical global impressions, and suicidality tracking. Safety and adverse events are also monitored from implantation through 12 months.
CONDITIONS
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of major depressive disorder (MDD) episode lasting at least two years or at least four episodes including the current one
- History of at least four failed treatments for depression at adequate doses and durations
- Experiencing a major depressive episode confirmed by a depression scale assessment on two visits within 45 days before VNS device implantation
- Stable medication regimen for at least four weeks before implantation
You will not qualify if you...
- Current or past history of psychotic features in any major depressive episode
- Current or past history of schizophrenia or schizoaffective disorder
- Current or past history of any other psychotic disorder
- Current or past history of rapid cycling bipolar disorder
- Current diagnosis of delirium, dementia, amnesia, or other cognitive disorder
- Current suicidal intent
- Treatment with another investigational device or investigational drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits to confirm diagnosis and stability of medication regimen before device implantation
Implementation
Duration - 1 day
Participants receive implantation of the Vagus Nerve Stimulation (VNS) device.
1 visit (in-person) for device implantation
Run-in Period
Duration - At least 2 weeks
Participants recover from implantation and device activation is delayed for at least 2 weeks.
No specific visits required during this period
Treatment
Duration - 12 months
Participants receive either active VNS stimulation starting at 2 weeks post-implant or no stimulation for the first 12 months as part of the randomized controlled trial.
Regular visits for monitoring and assessments during the 12-month treatment period
Post-treatment Follow-up
Duration - Up to 5 years
After the 12-month treatment period, participants in the control group may receive activation of the VNS device, and all participants continue in a long-term open-label study for up to approximately 5 years.
Visits occur periodically for long-term monitoring and assessments
Trial Site Locations
Total: 98 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
UAB Huntsville Regional Medical Center
Huntsville, Alabama, United States, 35801
Actively Recruiting
3
Access Multi Specialty Medical Clinic, Inc
Burlingame, California, United States, 94010
Terminated
4
CMB Clinical Trials
Colton, California, United States, 92324
Withdrawn
5
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
Actively Recruiting
6
Kaizen Brain Center
La Jolla, California, United States, 92037
Actively Recruiting
7
Keck Hospital of USC
Los Angeles, California, United States, 90033
Actively Recruiting
8
University of California San Diego
San Diego, California, United States, 92103
Active, Not Recruiting
9
SF-CARE, Inc.
San Rafael, California, United States, 94901
Terminated
10
Syrentis Clinical Research
Santa Ana, California, United States, 92705
Withdrawn
11
Sunrise Research Institute
Boca Raton, Florida, United States, 33325
Terminated
12
Mindful Behavioral Health
Boca Raton, Florida, United States, 33431
Actively Recruiting
13
Medycal Research, Inc
Brooksville, Florida, United States, 34609
Terminated
14
Galiz Research LLC
Hialeah, Florida, United States, 33016
Actively Recruiting
15
Florida Behavioral Psych
Largo, Florida, United States, 33770
Actively Recruiting
16
Segal Trials Corporate
Lauderhill, Florida, United States, 33319
Withdrawn
17
Central Miami Medical Institute, LLC
Miami, Florida, United States, 33125
Withdrawn
18
Clintex Research Group, Inc.
Miami, Florida, United States, 33135
Terminated
19
Research Center Of Florida, Inc
Miami, Florida, United States, 33135
Withdrawn
20
Ocean Blue Medical Research Center
Miami Springs, Florida, United States, 33166
Withdrawn
21
APG Research, LLC
Orlando, Florida, United States, 32803
Actively Recruiting
22
Nova Psychiatry Inc.
Orlando, Florida, United States, 32803
Actively Recruiting
23
Florida Center for TMS
Orlando, Florida, United States, 32806
Terminated
24
Millenia Psychiatry & Research, Inc
Orlando, Florida, United States, 32819
Withdrawn
25
Quantum Laboratories Inc.
Pompano Beach, Florida, United States, 33064
Terminated
26
Advanced Mental Health Care Inc.
Royal Palm Beach, Florida, United States, 33411
Actively Recruiting
27
Florida Center for TMS
Saint Augustine, Florida, United States, 94901
Actively Recruiting
28
Stedman Clinical Trials
Tampa, Florida, United States, 33613
Actively Recruiting
29
Psychiatric Specialty Center
West Palm Beach, Florida, United States, 33409
Terminated
30
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
31
Medical College of Georgia, Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
32
PACT Atlanta LLC
Decatur, Georgia, United States, 30030
Terminated
33
IACT Health
Grayson, Georgia, United States, 30017
Withdrawn
34
Psych Atlanta
Marietta, Georgia, United States, 30060
Actively Recruiting
35
Pearl Health Clinic
Ammon, Idaho, United States, 83406
Withdrawn
36
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
37
Joliet Center For Clinical Research
Joliet, Illinois, United States, 60435
Terminated
38
AMR- Baber Research, Inc.
Naperville, Illinois, United States, 60563
Actively Recruiting
39
Psychiatric Medicine Associates, LLC
Skokie, Illinois, United States, 60076
Actively Recruiting
40
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
Actively Recruiting
41
Neuroscience Research Institute
Winfield, Illinois, United States, 60910
Withdrawn
42
Advanced Research Institute, Inc.
Indianapolis, Indiana, United States, 56268
Terminated
43
Beacon Medical Group Behavioral Health
South Bend, Indiana, United States, 46601
Active, Not Recruiting
44
University Of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
45
Sheppard Pratt Health System, Inc.
Baltimore, Maryland, United States, 21204
Actively Recruiting
46
Clinical Insights
Glen Burnie, Maryland, United States, 21061
Withdrawn
47
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
48
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States, 48105
Active, Not Recruiting
49
University of Minnesota
Minneapolis, Minnesota, United States, 55416
Actively Recruiting
50
Precise Research Centers
Flowood, Mississippi, United States, 39232
Actively Recruiting
51
Andrew Bishop, MD
Jackson, Mississippi, United States, 39216
Terminated
52
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
53
Psychiatric Care and Research
O'Fallon, Missouri, United States, 633668
Actively Recruiting
54
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
55
PsychCare Consultants Research
St Louis, Missouri, United States, 63128
Actively Recruiting
56
Alivation Research, LLC
Lincoln, Nebraska, United States, 68526
Actively Recruiting
57
Healthy Perspective
Nashua, New Hampshire, United States, 03060
Actively Recruiting
58
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Withdrawn
59
University of New Mexico - Psychiatric Center
Albuquerque, New Mexico, United States, 87102
Withdrawn
60
Dent Neurological Institute
Amherst, New York, United States, 14226
Actively Recruiting
61
Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
Buffalo, New York, United States, 14215
Withdrawn
62
Trinity Medical
Lewiston, New York, United States, 14092
Actively Recruiting
63
Hapworth Research Inc.
New York, New York, United States, 10019
Actively Recruiting
64
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
65
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
Withdrawn
66
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Terminated
67
State University Of New York Upstate Medical University
Syracuse, New York, United States, 13210
Terminated
68
ManuMind Interventional Psychiatry
Woodbury, New York, United States, 11797
Actively Recruiting
69
The Center for Neuropsychiatry and Brain Stimulation (CNBS) ARC Health
Cary, North Carolina, United States, 27519
Terminated
70
Mindpath Care Centers
Raleigh, North Carolina, United States, 27606
Terminated
71
Wake Forest University Health Science
Winston-Salem, North Carolina, United States, 27103
Withdrawn
72
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Withdrawn
73
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
74
Signature Research Associates, Inc.
Fairlawn, Ohio, United States, 44333
Active, Not Recruiting
75
Charak Center for Health and Wellness
Garfield Heights, Ohio, United States, 44125
Actively Recruiting
76
NPC Research
Oklahoma City, Oklahoma, United States, 73109-3834
Withdrawn
77
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States, 73112
Terminated
78
University of Oklahoma School of Community Medicine
Tulsa, Oklahoma, United States, 74135
Actively Recruiting
79
Scranton Medical Institutes
Moosic, Pennsylvania, United States, 18507
Actively Recruiting
80
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
81
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
82
Neuroscience and TMS Treatment Center
Brentwood, Tennessee, United States, 37027
Actively Recruiting
83
UT Health Austin, Mulva Clinic for the Neurosciences
Austin, Texas, United States, 78712
Actively Recruiting
84
BioBehavioral Research of Austin
Austin, Texas, United States, 78759
Terminated
85
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
86
Texas Tech University Health Science Center
El Paso, Texas, United States, 79905
Actively Recruiting
87
The University Of Texas Medical School At Houston - UT Center Of Excellence On Mood Disorders
Houston, Texas, United States, 77054
Actively Recruiting
88
Houston Clinical Trials
Houston, Texas, United States, 77401
Terminated
89
Northpointe Psychiatry
Lewisville, Texas, United States, 75057
Actively Recruiting
90
Rise Clinical Research, LLC
Missouri City, Texas, United States, 77459
Terminated
91
The University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
92
Neuropsychiatric Associates, Plc
Woodstock, Vermont, United States, 05091
Terminated
93
Carilion Clinic
Roanoke, Virginia, United States, 24014
Actively Recruiting
94
Center For Anxiety and Depression
Mercer Island, Washington, United States, 98040
Actively Recruiting
95
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, United States, 98104
Actively Recruiting
96
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, United States, 25701
Actively Recruiting
97
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, United States, 26506
Withdrawn
98
University of Wisconsin
Madison, Wisconsin, United States, 53719
Actively Recruiting
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Research Team
L
Laura Yates, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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