Treatment-Resistant Depression Registry

Recruiting in Palo Alto (17 mi)

+54 other locations

Overseen by Herbert Ward, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cyberonics, Inc.

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Adam K. Ashton, MD

Principal Investigator

Suburban Psychiatric Associates

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

Principal Investigator

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

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

Harold McGrath, MD

Principal Investigator

McGarth Clinic

Herbert Ward, MD

Principal Investigator

University of Florida

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.

Treatment Details

Interventions

• VNS Therapy (Behavioural Intervention)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

McGrath Clinic Evergreen Park, IL

3c Methodist Hospital Indianapolis, IN

Sutter Institute for Medical Research Sacramento, CA

University of Massachusetts Medical School Worcester, MA

More Trial Locations

Who Is Running the Clinical Trial?

Cyberonics, Inc.

Lead Sponsor

Trials

23

Patients Recruited

3,100+