Treatment-Resistant Depression Registry

NCT00320372 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 795

Last updated 2015-12-23

Study results available
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Summary

This registry will collect information about patients with treatment-resistant depression (TRD) who are currently in a major depressive episode. For the purposes of this study, TRD is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3 times, to include the current episode, during the patient's lifetime AND has not adequately responded to 4 or more adequate antidepressive treatments. The registry will follow the clinical course and outcomes for patients with TRD who are treated with and without adjunctive (used along with other treatments for depression) vagus nerve stimulation (VNS) therapy.

Conditions

Sponsors & Collaborators

  • Cyberonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Adam K. Ashton, MD · Suburban Psychiatric Associates

  • Herbert Ward, MD · University of Florida

  • Thomas Schwartz, MD · SUNY UMU at Syracuse

  • Mark Zetin, MD · Private Practice

  • Darin D. Dougherty, MD · Massachusetts General Hospital

  • George Keepers, MD · Oregon Health and Science University

  • Mustafa M. Husain, MD · UT Southwestern Medical Center at Dallas

  • Leighton Y. Huey, MD · UConn Health

  • James Kimball, MD · Wake Forest University Health Sciences

  • Peter J. Holland, MD · Florida Atlantic University

  • Robert Howland, MD · Western Psychiatric Institute & Clinic (WPIC)

  • Anthony Rothschild, MD · University of Massachusetts, Worcester

  • Craig J Vine, MD · Psychiatric Recovery

  • Joel Young, MD · Rochester Center for Behavioral Science

  • Lawrence W Adler, MD · Clinical Insights

  • Harold Harsch, MD · Medical College of Wisconsin

  • Syed Ali, MD · Dupage Mental Health Services

  • Keming Gao, MD · University Hospitals Cleveland Medical Center

  • Todd M. Antin, M.D., DFAPA · Pact Atlanta, LLC

  • Basanti Basu, M.D. · Century Health

  • Dwight Bearden, MD · Private Practice

  • David L. Dunner, MD · Center for Anxiety and Depression

  • Azfar Malik, MD · Psych Care Consultants Research

  • Joel Morgan, MD · Valdosta Psychiatric Associates LLC

  • Mark George, MD · Medical University of South Carolina

  • Frederick W. Reimherr, MD · Psychiatric & Behavorial Solutions

  • John Zajecka, MD · Psychiatric Medicine Associates, LLC

  • Michael Banov, MD · Northwest Behavioral Research Center

  • Robert Lehman, MD · Pharmasite Research, Inc.

  • Scott Aaronson, MD · Sheppard Pratt Health Systems, Inc.

  • Jaishree Narayanan, MD · Endeavor Health

  • Greg Seal, MD · Louisiana Clinical Research, LLC

  • Horacio Capote, MD · Dent Neurologic Institute

  • Charles Conway, MD · Washington University School of Medicine

  • Michael Lesem, MD · Claghorn-Lesem Reserach Clinic, Ltd.

  • Miguel Martelli, MD · MG Martelli, MD, PC and Associates

  • Ananda Pandurangi, MD · Virginia Commonwealth University

  • Peter Thompson, MD · The University of Texas Health Science Center at San Antonio

  • Theodore Goodman, MD · Sutter Institute for Medical Research

  • Francisco Moreno, MD · University of Arizona

  • Martha Edelman, MD · Jamaica Hospital Medical Center

  • Peter Bulow, MD · Columbia University

  • Mark Bunker · Cyberonics, Inc.

  • Mahendra Bhati, MD · University of Pennsylvania

  • Ronald Warnell, MD · Loma Linda University

  • Robert Cohen, MD · Cedars-Sinai Hospital

  • Janak Mehtani, MD · Fair Oaks Psychiatric Associates

  • Mounir Soliman, MD · University of California, San Diego

  • Francisco Fernandez, MD · University of South Florida

  • Arthur Holt, MD · Arthur Holt, Private Practice

  • Harold McGrath, MD · McGarth Clinic

  • Anthony D'Agostino, MD · Alexian Brothers Behavioral Health Hospital

  • Anne Gilbert, MD · 3c Methodist Hospital

  • Michael Burke, MD · Clinical Research Institute

  • Ed Coffey, MD · Henry Ford Health Services

  • Joseph Kwentus, MD · University of Mississippi Medical Center

  • David Ginsberg, MD · New York University of Medical Center

  • Melissa Martinez, MD · Baylor College of Medicine

  • Arnold Mech, MD · The Mech Center

  • Joseph Simpson, MD · Alamo Superior Research

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00320372 on ClinicalTrials.gov