A Long-term, Prospective, Observational, Multi-center Patient Outcome Registry to Collect Data in Patients With Treatment-resistant Depression (TRD) Who Are Currently in a Major Depressive Episode.
Sponsor study identifier
observational
795
1 country
55
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
May 1, 2006
Actual (reported)May 3, 2006
Actual (reported)March 2015
Actual (reported)May 2015
Actual (reported)December 23, 2015
Actual (reported)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)
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
VNS Patients - Treatment-resistant depression patients treated with VNS Therapy.
Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy.
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.
University of Arizona
Tucson, Arizona, 85724, United States
Cedars-Sinai Hospital
Beverly Hills, California, United States
Mark Zetin, MD - Private Practice
Garden Grove, California, 92840, United States
Loma Linda University
Loma Linda, California, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
Fair Oaks Psychiatric Associates
Sacramento, California, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030-1410, United States
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.
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.
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
795 participants (actual enrollment reported by the registry).
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Continuation Ketamine in Major Depression
Contact the study team to confirm eligibility.
Florida Atlantic University
Boca Raton, Florida, 33431, United States
University of Florida
Gainesville, Florida, 32610-0256, United States
MG Martelli, MD, PC and Associates
Brunswick, Georgia, 31520, United States
Arthur Holt, Private Practice
Columbus, Georgia, United States
Pact Atlanta, LLC
Decatur, Georgia, 30030, United States
Private Practice
Macon, Georgia, 31201, United States
Northwest Behavioral Research Center
Marietta, Georgia, 30060, United States
Valdosta Psychiatric Associates LLC
Valdosta, Georgia, 31602, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
McGrath Clinic
Evergreen Park, Illinois, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, 60076, United States
Dupage Mental Health Services
Wheaton, Illinois, 60187, United States
3c Methodist Hospital
Indianapolis, Indiana, United States
Clinical Research Institute
Wichita, Kansas, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71115, United States
Pharmasite Research Inc.
Baltimore, Maryland, 21208, United States
Sheppard Pratt Health Systems, Inc.
Baltimore, Maryland, 21285, United States
Clinical Insights
Glen Burnie, Maryland, 21061, United States
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01605, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
Psychiatric Recovery
Saint Paul, Minnesota, 55114, United States
Precise Research Centers
Flowood, Mississippi, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Psych Care Consultants Research
St Louis, Missouri, 63128, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Suburban Psychiatric Associates
Amherst, New York, 14228, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Columbia University
New York, New York, 10032, United States
SUNY UMU at Syracuse
Syracuse, New York, 13210, United States
Wake Forest University - Health Sciences
Winston-Salem, North Carolina, 27157, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Century Health
Findlay, Ohio, 45840, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Western Psychiatric Institute & Clinic (WPIC)
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8898, United States
Claghorn-Lesem Reserach Clinic, Ltd.
Houston, Texas, 77008, United States
Baylor College of Medicine
Houston, Texas, United States
The Mech Center
Plano, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Alamo Superior Research
San Antonio, Texas, United States
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, 84105, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Center for Anxiety and Depression
Mercer Island, Washington, 98040, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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.
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.
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.
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.
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
Primary Completion
March 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
December 23, 2015
Results First Posted
December 23, 2015
Record last verified: 2015-12
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