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Search / Trial NCT00320372

Treatment-Resistant Depression Registry

Launched by CYBERONICS, INC. · May 1, 2006

Trial Information

Current as of April 29, 2025

Completed

Keywords

Major Depressive Disorder Treatment Resistant Depression

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.

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

0 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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