Treatment-Resistant Depression Registry
Launched by CYBERONICS, INC. · May 1, 2006
Trial Information
Current as of April 29, 2025
Completed
Keywords
ClinConnect Summary
Enrollment of TRD patients treated with VNS Therapy will consist of patients originally enrolled in the registry as well as patients who have completed the D-21 Dosing Study and are enrolled in the Registry for Long-Term Follow-up. Sites will maintain a screening log of all patients who have been screened for original TRD Registry patients.
Please note that because this is a post-approval registry, Cyberonics does not cover the cost of VNS Therapy implantation.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patient diagnosed with a current major depressive episode according to DSM-IV-TR 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 has a history of schizophrenia, schizoaffective disorder, any other psychotic disorder, or a current major depressive episode that includes psychotic features; or is currently psychotic.
- • 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.
About Cyberonics, Inc.
Cyberonics, Inc. is a pioneering medical device company specializing in innovative therapies for neurological disorders. With a strong focus on developing advanced neuromodulation technologies, Cyberonics is dedicated to improving the quality of life for patients suffering from epilepsy and treatment-resistant depression. The company's flagship product, the Vagus Nerve Stimulator (VNS), exemplifies its commitment to research and clinical excellence. Cyberonics collaborates with healthcare professionals and research institutions to conduct clinical trials that validate the safety and efficacy of its therapies, driving forward the field of neuromodulation and expanding treatment options for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Sacramento, California, United States
Philadelphia, Pennsylvania, United States
New York, New York, United States
Milwaukee, Wisconsin, United States
San Antonio, Texas, United States
Tucson, Arizona, United States
Charleston, South Carolina, United States
Worcester, Massachusetts, United States
Portland, Oregon, United States
Richmond, Virginia, United States
St. Louis, Missouri, United States
Amherst, New York, United States
Jamaica, New York, United States
Glen Burnie, Maryland, United States
Loma Linda, California, United States
Cleveland, Ohio, United States
Evanston, Illinois, United States
Boca Raton, Florida, United States
St. Louis, Missouri, United States
Marietta, Georgia, United States
Baltimore, Maryland, United States
Charlestown, Massachusetts, United States
St. Paul, Minnesota, United States
Mercer Island, Washington, United States
Beverly Hills, California, United States
Garden Grove, California, United States
Sacramento, California, United States
Farmington, Connecticut, United States
Gainesville, Florida, United States
Brunswick, Georgia, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Valdosta, Georgia, United States
Evergreen Park, Illinois, United States
Hoffman Estates, Illinois, United States
Skokie, Illinois, United States
Wheaton, Illinois, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Rochester Hills, Michigan, United States
Flowood, Mississippi, United States
Amherst, New York, United States
Syracuse, New York, United States
Winston Salem, North Carolina, United States
Findlay, Ohio, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Patients applied
Trial Officials
Adam K. Ashton, MD
Principal Investigator
Suburban Psychiatric Associates
Herbert Ward, MD
Principal Investigator
University of Florida
Thomas Schwartz, MD
Principal Investigator
SUNY UMU at Syracuse
Mark Zetin, MD
Principal Investigator
Private Practice
Darin D. Dougherty, MD
Principal Investigator
Massachusetts General Hospital
George Keepers, MD
Principal Investigator
Oregon Health and Science University
Mustafa M. Husain, MD
Principal Investigator
UT Southwestern Medical Center at Dallas
Leighton Y. Huey, MD
Principal Investigator
UConn Health
James Kimball, MD
Principal Investigator
Wake Forest University Health Sciences
Peter J. Holland, MD
Principal Investigator
Florida Atlantic University
Robert Howland, MD
Principal Investigator
Western Psychiatric Institute & Clinic (WPIC)
Anthony Rothschild, MD
Principal Investigator
University of Massachusetts, Worcester
Craig J Vine, MD
Principal Investigator
Psychiatric Recovery
Joel Young, MD
Principal Investigator
Rochester Center for Behavioral Science
Lawrence W Adler, MD
Principal Investigator
Clinical Insights
Harold Harsch, MD
Principal Investigator
Medical College of Wisconsin
Syed Ali, MD
Principal Investigator
Dupage Mental Health Services
Keming Gao, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Todd M. Antin, M.D., DFAPA
Principal Investigator
Pact Atlanta, LLC
Basanti Basu, M.D.
Principal Investigator
Century Health
Dwight Bearden, MD
Principal Investigator
Private Practice
David L. Dunner, MD
Principal Investigator
Center for Anxiety and Depression
Azfar Malik, MD
Principal Investigator
Psych Care Consultants Research
Joel Morgan, MD
Principal Investigator
Valdosta Psychiatric Associates LLC
Mark George, MD
Principal Investigator
Medical University of South Carolina
Frederick W. Reimherr, MD
Principal Investigator
Psychiatric & Behavorial Solutions
John Zajecka, MD
Principal Investigator
Psychiatric Medicine Associates, LLC
Michael Banov, MD
Principal Investigator
Northwest Behavioral Research Center
Robert Lehman, MD
Principal Investigator
Pharmasite Research, Inc.
Scott Aaronson, MD
Principal Investigator
Sheppard Pratt Health Systems, Inc.
Jaishree Narayanan, MD
Principal Investigator
Endeavor Health
Greg Seal, MD
Principal Investigator
Louisiana Clinical Research, LLC
Horacio Capote, MD
Principal Investigator
Dent Neurologic Institute
Charles Conway, MD
Principal Investigator
Washington University School of Medicine
Michael Lesem, MD
Principal Investigator
Claghorn-Lesem Reserach Clinic, Ltd.
Miguel Martelli, MD
Principal Investigator
MG Martelli, MD, PC and Associates
Ananda Pandurangi, MD
Principal Investigator
Virginia Commonwealth University
Peter Thompson, MD
Principal Investigator
The University of Texas Health Science Center at San Antonio
Theodore Goodman, MD
Principal Investigator
Sutter Institute for Medical Research
Francisco Moreno, MD
Principal Investigator
University of Arizona
Martha Edelman, MD
Principal Investigator
Jamaica Hospital Medical Center
Peter Bulow, MD
Principal Investigator
Columbia University
Mark Bunker
Study Director
Cyberonics, Inc.
Mahendra Bhati, MD
Principal Investigator
University of Pennsylvania
Ronald Warnell, MD
Principal Investigator
Loma Linda University
Robert Cohen, MD
Principal Investigator
Cedars-Sinai Hospital
Janak Mehtani, MD
Principal Investigator
Fair Oaks Psychiatric Associates
Mounir Soliman, MD
Principal Investigator
University of California, San Diego
Francisco Fernandez, MD
Principal Investigator
University of South Florida
Arthur Holt, MD
Principal Investigator
Arthur Holt, Private Practice
Harold McGrath, MD
Principal Investigator
McGarth Clinic
Anthony D'Agostino, MD
Principal Investigator
Alexian Brothers Behavioral Health Hospital
Anne Gilbert, MD
Principal Investigator
3c Methodist Hospital
Michael Burke, MD
Principal Investigator
Clinical Research Institute
Ed Coffey, MD
Principal Investigator
Henry Ford Health Services
Joseph Kwentus, MD
Principal Investigator
University of Mississippi Medical Center
David Ginsberg, MD
Principal Investigator
New York University of Medical Center
Melissa Martinez, MD
Principal Investigator
Baylor College of Medicine
Arnold Mech, MD
Principal Investigator
The Mech Center
Joseph Simpson, MD
Principal Investigator
Alamo Superior Research
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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