Treatment-Resistant Depression Registry

NCT00320372 | Completed Results

• 1 other identifier: TRD Registry
• Study Type: observational
• Target: 795
• Locations: 1 country
• Sites: 55

Brief 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

Major Depressive Disorder

Keywords

Major Depressive Disorder; Treatment-resistant Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline)

  Response Rate was computed and summarized as the proportion of patients that achieved ≥ 50% reduction from baseline in MADRS total score at each post-baseline visit. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen. A patient was considered a "Responder" (Yes = 1) if achieved ≥ 50% reduction from baseline in MADRS total score at visit month assessment post-baseline. A "Non-Responder" (No = 0) was any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at visit month assessment post-baseline. Total number of patients in each group may be lower than ITT in a case of missing assessment data.

  3-Month Through 60-Month (Post Baseline)

Secondary Outcomes (6)

• Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS)

  3-Month Through 60-Month (Post Baseline)

• Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline)

  3-Month Through 60-Month (Post Baseline)

• Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation

  1 Week Pre-Baseline

• Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture

  Baseline

• Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture

  Baseline

Study Arms (2)

1. 500 VNS Patients

VNS Patients - Treatment-resistant depression patients treated with VNS Therapy.

2. 300 Non-VNS Patients

Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic depression that is at least two years in duration or a recurrent depression that includes at least three lifetime episodes including the current major depressive episode (MDE); and an inadequate response to four or more adequate antidepressant treatments.

You may qualify if:

• Patient diagnosed with a current major depressive episode according to DSM-IV-TR criteria.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (55)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Hospital

Beverly Hills, California, United States

Location

Mark Zetin, MD - Private Practice

Garden Grove, California, 92840, United States

Location

Loma Linda University

Loma Linda, California, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Fair Oaks Psychiatric Associates

Sacramento, California, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030-1410, United States

Location

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

University of Florida

Gainesville, Florida, 32610-0256, United States

Location

MG Martelli, MD, PC and Associates

Brunswick, Georgia, 31520, United States

Location

Arthur Holt, Private Practice

Columbus, Georgia, United States

Location

Pact Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Private Practice

Macon, Georgia, 31201, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Valdosta Psychiatric Associates LLC

Valdosta, Georgia, 31602, United States

Location

Northshore University Health System

Evanston, Illinois, 60201, United States

Location

McGrath Clinic

Evergreen Park, Illinois, United States

Location

Alexian Brothers Behavioral Health Hospital

Hoffman Estates, Illinois, United States

Location

Psychiatric Medicine Associates, LLC

Skokie, Illinois, 60076, United States

Location

Dupage Mental Health Services

Wheaton, Illinois, 60187, United States

Location

3c Methodist Hospital

Indianapolis, Indiana, United States

Location

Clinical Research Institute

Wichita, Kansas, United States

Location

Louisiana Clinical Research, LLC

Shreveport, Louisiana, 71115, United States

Location

Pharmasite Research Inc.

Baltimore, Maryland, 21208, United States

Location

Sheppard Pratt Health Systems, Inc.

Baltimore, Maryland, 21285, United States

Location

Clinical Insights

Glen Burnie, Maryland, 21061, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Psychiatric Recovery

Saint Paul, Minnesota, 55114, United States

Location

Precise Research Centers

Flowood, Mississippi, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Psych Care Consultants Research

St Louis, Missouri, 63128, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Suburban Psychiatric Associates

Amherst, New York, 14228, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Columbia University

New York, New York, 10032, United States

Location

SUNY UMU at Syracuse

Syracuse, New York, 13210, United States

Location

Wake Forest University - Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Century Health

Findlay, Ohio, 45840, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Western Psychiatric Institute & Clinic (WPIC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8898, United States

Location

Claghorn-Lesem Reserach Clinic, Ltd.

Houston, Texas, 77008, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

The Mech Center

Plano, Texas, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Alamo Superior Research

San Antonio, Texas, United States

Location

Psychiatric & Behavioral Solutions

Salt Lake City, Utah, 84105, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Center for Anxiety and Depression

Mercer Island, Washington, 98040, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (6)

• 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.

  PMID: 16139581 BACKGROUND

• 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.

  PMID: 16139580 BACKGROUND

• 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.

  PMID: 16139582 BACKGROUND

• 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.

  PMID: 20473062 BACKGROUND

• 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.

  PMID: 32358769 DERIVED

• 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.

  PMID: 28359201 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Mark Bunker, PharmD, Sr. Director, Global Medical Affairs
• Organization: Cyberonics, Inc

mark.bunker@cyberonics.com

281-228-7223

Study Officials

• Adam K. Ashton, MD

  Suburban Psychiatric Associates

  PRINCIPAL INVESTIGATOR

• Herbert Ward, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Thomas Schwartz, MD

  SUNY UMU at Syracuse

  PRINCIPAL INVESTIGATOR

• Mark Zetin, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

• Darin D. Dougherty, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• George Keepers, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Mustafa M. Husain, MD

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Leighton Y. Huey, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

• James Kimball, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Peter J. Holland, MD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

• Robert Howland, MD

  Western Psychiatric Institute & Clinic (WPIC)

  PRINCIPAL INVESTIGATOR

• Anthony Rothschild, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Craig J Vine, MD

  Psychiatric Recovery

  PRINCIPAL INVESTIGATOR

• Joel Young, MD

  Rochester Center for Behavioral Science

  PRINCIPAL INVESTIGATOR

• Lawrence W Adler, MD

  Clinical Insights

  PRINCIPAL INVESTIGATOR

• Harold Harsch, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Syed Ali, MD

  Dupage Mental Health Services

  PRINCIPAL INVESTIGATOR

• Keming Gao, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Todd M. Antin, M.D., DFAPA

  Pact Atlanta, LLC

  PRINCIPAL INVESTIGATOR

• Basanti Basu, M.D.

  Century Health

  PRINCIPAL INVESTIGATOR

• Dwight Bearden, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

• David L. Dunner, MD

  Center for Anxiety and Depression

  PRINCIPAL INVESTIGATOR

• Azfar Malik, MD

  Psych Care Consultants Research

  PRINCIPAL INVESTIGATOR

• Joel Morgan, MD

  Valdosta Psychiatric Associates LLC

  PRINCIPAL INVESTIGATOR

• Mark George, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Frederick W. Reimherr, MD

  Psychiatric & Behavorial Solutions

  PRINCIPAL INVESTIGATOR

• John Zajecka, MD

  Psychiatric Medicine Associates, LLC

  PRINCIPAL INVESTIGATOR

• Michael Banov, MD

  Northwest Behavioral Research Center

  PRINCIPAL INVESTIGATOR

• Robert Lehman, MD

  Pharmasite Research, Inc.

  PRINCIPAL INVESTIGATOR

• Scott Aaronson, MD

  Sheppard Pratt Health Systems, Inc.

  PRINCIPAL INVESTIGATOR

• Jaishree Narayanan, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

• Greg Seal, MD

  Louisiana Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

• Horacio Capote, MD

  Dent Neurologic Institute

  PRINCIPAL INVESTIGATOR

• Charles Conway, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Michael Lesem, MD

  Claghorn-Lesem Reserach Clinic, Ltd.

  PRINCIPAL INVESTIGATOR

• Miguel Martelli, MD

  MG Martelli, MD, PC and Associates

  PRINCIPAL INVESTIGATOR

• Ananda Pandurangi, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Peter Thompson, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Theodore Goodman, MD

  Sutter Institute for Medical Research

  PRINCIPAL INVESTIGATOR

• Francisco Moreno, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Martha Edelman, MD

  Jamaica Hospital Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Bulow, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Mark Bunker

  Cyberonics, Inc.

  STUDY DIRECTOR

• Mahendra Bhati, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Ronald Warnell, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

• Robert Cohen, MD

  Cedars-Sinai Hospital

  PRINCIPAL INVESTIGATOR

• Janak Mehtani, MD

  Fair Oaks Psychiatric Associates

  PRINCIPAL INVESTIGATOR

• Mounir Soliman, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Francisco Fernandez, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Arthur Holt, MD

  Arthur Holt, Private Practice

  PRINCIPAL INVESTIGATOR

• Harold McGrath, MD

  McGarth Clinic

  PRINCIPAL INVESTIGATOR

• Anthony D'Agostino, MD

  Alexian Brothers Behavioral Health Hospital

  PRINCIPAL INVESTIGATOR

• Anne Gilbert, MD

  3c Methodist Hospital

  PRINCIPAL INVESTIGATOR

• Michael Burke, MD

  Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Ed Coffey, MD

  Henry Ford Health Services

  PRINCIPAL INVESTIGATOR

• Joseph Kwentus, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

• David Ginsberg, MD

  New York University of Medical Center

  PRINCIPAL INVESTIGATOR

• Melissa Martinez, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Arnold Mech, MD

  The Mech Center

  PRINCIPAL INVESTIGATOR

• Joseph Simpson, MD

  Alamo Superior Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: January 1, 2006
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 23, 2015
• Results First Posted: December 23, 2015

Record last verified: 2015-12

Locations

US (55)