Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
795 participants
OBSERVATIONAL
2006-01-31
2015-05-31
Brief Summary
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Detailed Description
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Please note that because this is a post-approval registry, Cyberonics does not cover the cost of VNS Therapy implantation.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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1. 500 VNS Patients
VNS Patients - Treatment-resistant depression patients treated with VNS Therapy.
No interventions assigned to this group
2. 300 Non-VNS Patients
Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* For D-21 patients only who have completed the D-21 dosing Study without any D-21 inclusion and exclusion protocol deviation.
* Patient has been in the current depressive episode for 2 years or longer, or has had at least 3 lifetime episodes including the current MDE.
* Patient has had an inadequate response to 4 or more adequate antidepressive treatments.
* The patient has a CGI severity of illness score of moderately ill (score of 4) or greater.
* The patient must be able to provide informed consent and complete all forms.
Exclusion Criteria
* Patient is currently enrolled in a double blind investigational study; patients who have completed the double-blind D-21 study will be allowed to enter the Registry for Long Term Follow-up
* Other than those patients who were enrolled in the D-21 study, patient has previously received VNS therapy.
* Patient has a history of rapid cycling bipolar disorder.
18 Years
ALL
No
Sponsors
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Cyberonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Martinez, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Arnold Mech, MD
Role: PRINCIPAL_INVESTIGATOR
The Mech Center
Joseph Simpson, MD
Role: PRINCIPAL_INVESTIGATOR
Alamo Superior Research
Adam K. Ashton, MD
Role: PRINCIPAL_INVESTIGATOR
Suburban Psychiatric Associates
Herbert Ward, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Thomas Schwartz, MD
Role: PRINCIPAL_INVESTIGATOR
SUNY UMU at Syracuse
Mark Zetin, MD
Role: PRINCIPAL_INVESTIGATOR
Private Practice
Darin D. Dougherty, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
George Keepers, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Mustafa M. Husain, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center at Dallas
Leighton Y. Huey, MD
Role: PRINCIPAL_INVESTIGATOR
UConn Health
James Kimball, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Peter J. Holland, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Atlantic University
Robert Howland, MD
Role: PRINCIPAL_INVESTIGATOR
Western Psychiatric Institute & Clinic (WPIC)
Anthony Rothschild, MD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Craig J Vine, MD
Role: PRINCIPAL_INVESTIGATOR
Psychiatric Recovery
Joel Young, MD
Role: PRINCIPAL_INVESTIGATOR
Rochester Center for Behavioral Science
Lawrence W Adler, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Insights
Harold Harsch, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Syed Ali, MD
Role: PRINCIPAL_INVESTIGATOR
Dupage Mental Health Services
Keming Gao, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Todd M. Antin, M.D., DFAPA
Role: PRINCIPAL_INVESTIGATOR
Pact Atlanta, LLC
Basanti Basu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Century Health
Dwight Bearden, MD
Role: PRINCIPAL_INVESTIGATOR
Private Practice
David L. Dunner, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Anxiety and Depression
Azfar Malik, MD
Role: PRINCIPAL_INVESTIGATOR
Psych Care Consultants Research
Joel Morgan, MD
Role: PRINCIPAL_INVESTIGATOR
Valdosta Psychiatric Associates LLC
Mark George, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Frederick W. Reimherr, MD
Role: PRINCIPAL_INVESTIGATOR
Psychiatric & Behavorial Solutions
John Zajecka, MD
Role: PRINCIPAL_INVESTIGATOR
Psychiatric Medicine Associates, LLC
Michael Banov, MD
Role: PRINCIPAL_INVESTIGATOR
Northwest Behavioral Research Center
Robert Lehman, MD
Role: PRINCIPAL_INVESTIGATOR
Pharmasite Research, Inc.
Scott Aaronson, MD
Role: PRINCIPAL_INVESTIGATOR
Sheppard Pratt Health Systems, Inc.
Jaishree Narayanan, MD
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Greg Seal, MD
Role: PRINCIPAL_INVESTIGATOR
Louisiana Clinical Research, LLC
Horacio Capote, MD
Role: PRINCIPAL_INVESTIGATOR
Dent Neurologic Institute
Charles Conway, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Michael Lesem, MD
Role: PRINCIPAL_INVESTIGATOR
Claghorn-Lesem Reserach Clinic, Ltd.
Miguel Martelli, MD
Role: PRINCIPAL_INVESTIGATOR
MG Martelli, MD, PC and Associates
Ananda Pandurangi, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Peter Thompson, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Theodore Goodman, MD
Role: PRINCIPAL_INVESTIGATOR
Sutter Institute for Medical Research
Francisco Moreno, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Martha Edelman, MD
Role: PRINCIPAL_INVESTIGATOR
Jamaica Hospital Medical Center
Peter Bulow, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Mark Bunker
Role: STUDY_DIRECTOR
Cyberonics, Inc.
Mahendra Bhati, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Ronald Warnell, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Robert Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Hospital
Janak Mehtani, MD
Role: PRINCIPAL_INVESTIGATOR
Fair Oaks Psychiatric Associates
Mounir Soliman, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Francisco Fernandez, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Arthur Holt, MD
Role: PRINCIPAL_INVESTIGATOR
Arthur Holt, Private Practice
Harold McGrath, MD
Role: PRINCIPAL_INVESTIGATOR
McGarth Clinic
Anthony D'Agostino, MD
Role: PRINCIPAL_INVESTIGATOR
Alexian Brothers Behavioral Health Hospital
Anne Gilbert, MD
Role: PRINCIPAL_INVESTIGATOR
3c Methodist Hospital
Michael Burke, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Institute
Ed Coffey, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health Services
Joseph Kwentus, MD
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
David Ginsberg, MD
Role: PRINCIPAL_INVESTIGATOR
New York University of Medical Center
Locations
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University of Arizona
Tucson, Arizona, United States
Cedars-Sinai Hospital
Beverly Hills, California, United States
Mark Zetin, MD - Private Practice
Garden Grove, California, United States
Loma Linda University
Loma Linda, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Fair Oaks Psychiatric Associates
Sacramento, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Florida Atlantic University
Boca Raton, Florida, United States
University of Florida
Gainesville, Florida, United States
MG Martelli, MD, PC and Associates
Brunswick, Georgia, United States
Arthur Holt, Private Practice
Columbus, Georgia, United States
Pact Atlanta, LLC
Decatur, Georgia, United States
Private Practice
Macon, Georgia, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Valdosta Psychiatric Associates LLC
Valdosta, Georgia, United States
Northshore University Health System
Evanston, Illinois, United States
McGrath Clinic
Evergreen Park, Illinois, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, United States
Dupage Mental Health Services
Wheaton, Illinois, United States
3c Methodist Hospital
Indianapolis, Indiana, United States
Clinical Research Institute
Wichita, Kansas, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, United States
Pharmasite Research Inc.
Baltimore, Maryland, United States
Sheppard Pratt Health Systems, Inc.
Baltimore, Maryland, United States
Clinical Insights
Glen Burnie, Maryland, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
Psychiatric Recovery
Saint Paul, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
Washington University in St. Louis
St Louis, Missouri, United States
Psych Care Consultants Research
St Louis, Missouri, United States
Dent Neurologic Institute
Amherst, New York, United States
Suburban Psychiatric Associates
Amherst, New York, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Columbia University
New York, New York, United States
SUNY UMU at Syracuse
Syracuse, New York, United States
Wake Forest University - Health Sciences
Winston-Salem, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Century Health
Findlay, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Western Psychiatric Institute & Clinic (WPIC)
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Claghorn-Lesem Reserach Clinic, Ltd.
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The Mech Center
Plano, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Alamo Superior Research
San Antonio, Texas, United States
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Center for Anxiety and Depression
Mercer Island, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Rush AJ, Sackeim HA, Marangell LB, George MS, Brannan SK, Davis SM, Lavori P, Howland R, Kling MA, Rittberg B, Carpenter L, Ninan P, Moreno F, Schwartz T, Conway C, Burke M, Barry JJ. Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: a naturalistic study. Biol Psychiatry. 2005 Sep 1;58(5):355-63. doi: 10.1016/j.biopsych.2005.05.024.
Rush AJ, Marangell LB, Sackeim HA, George MS, Brannan SK, Davis SM, Howland R, Kling MA, Rittberg BR, Burke WJ, Rapaport MH, Zajecka J, Nierenberg AA, Husain MM, Ginsberg D, Cooke RG. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry. 2005 Sep 1;58(5):347-54. doi: 10.1016/j.biopsych.2005.05.025.
George MS, Rush AJ, Marangell LB, Sackeim HA, Brannan SK, Davis SM, Howland R, Kling MA, Moreno F, Rittberg B, Dunner D, Schwartz T, Carpenter L, Burke M, Ninan P, Goodnick P. A one-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression. Biol Psychiatry. 2005 Sep 1;58(5):364-73. doi: 10.1016/j.biopsych.2005.07.028.
Bajbouj M, Merkl A, Schlaepfer TE, Frick C, Zobel A, Maier W, O'Keane V, Corcoran C, Adolfsson R, Trimble M, Rau H, Hoff HJ, Padberg F, Muller-Siecheneder F, Audenaert K, van den Abbeele D, Matthews K, Christmas D, Eljamel S, Heuser I. Two-year outcome of vagus nerve stimulation in treatment-resistant depression. J Clin Psychopharmacol. 2010 Jun;30(3):273-81. doi: 10.1097/JCP.0b013e3181db8831.
McAllister-Williams RH, Sousa S, Kumar A, Greco T, Bunker MT, Aaronson ST, Conway CR, Rush AJ. The effects of vagus nerve stimulation on the course and outcomes of patients with bipolar disorder in a treatment-resistant depressive episode: a 5-year prospective registry. Int J Bipolar Disord. 2020 May 2;8(1):13. doi: 10.1186/s40345-020-0178-4.
Aaronson ST, Sears P, Ruvuna F, Bunker M, Conway CR, Dougherty DD, Reimherr FW, Schwartz TL, Zajecka JM. A 5-Year Observational Study of Patients With Treatment-Resistant Depression Treated With Vagus Nerve Stimulation or Treatment as Usual: Comparison of Response, Remission, and Suicidality. Am J Psychiatry. 2017 Jul 1;174(7):640-648. doi: 10.1176/appi.ajp.2017.16010034. Epub 2017 Mar 31.
Other Identifiers
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TRD Registry
Identifier Type: -
Identifier Source: org_study_id
NCT00657215
Identifier Type: -
Identifier Source: nct_alias