Treatment-Resistant Depression Registry

Major Depressive Disorder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320372
• Other study ID #: TRD Registry
• Status: Completed
• Phase: N/A
• First received: May 1, 2006
• Last updated: December 22, 2015
• Start date: January 2006
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Cyberonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Other known NCT identifiers

• NCT00657215

Recruitment information / eligibility

• Status: Completed
• Enrollment: 795
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York
United States	Suburban Psychiatric Associates	Amherst	New York
United States	Pharmasite Research Inc.	Baltimore	Maryland
United States	Sheppard Pratt Health Systems, Inc.	Baltimore	Maryland
United States	Cedars-Sinai Hospital	Beverly Hills	California
United States	Florida Atlantic University	Boca Raton	Florida
United States	MG Martelli, MD, PC and Associates	Brunswick	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Arthur Holt, Private Practice	Columbus	Georgia
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Pact Atlanta, LLC	Decatur	Georgia
United States	Northshore University Health System	Evanston	Illinois
United States	McGrath Clinic	Evergreen Park	Illinois
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Century Health	Findlay	Ohio
United States	Precise Research Centers	Flowood	Mississippi
United States	University of Florida	Gainesville	Florida
United States	Mark Zetin, MD - Private Practice	Garden Grove	California
United States	Clinical Insights	Glen Burnie	Maryland
United States	Alexian Brothers Behavioral Health Hospital	Hoffman Estates	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Claghorn-Lesem Reserach Clinic, Ltd.	Houston	Texas
United States	3c Methodist Hospital	Indianapolis	Indiana
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	Loma Linda University	Loma Linda	California
United States	Private Practice	Macon	Georgia
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	Center for Anxiety and Depression	Mercer Island	Washington
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Western Psychiatric Institute & Clinic (WPIC)	Pittsburgh	Pennsylvania
United States	The Mech Center	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Fair Oaks Psychiatric Associates	Sacramento	California
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Psychiatric & Behavioral Solutions	Salt Lake City	Utah
United States	Alamo Superior Research	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Louisiana Clinical Research, LLC	Shreveport	Louisiana
United States	Psychiatric Medicine Associates, LLC	Skokie	Illinois
United States	Psych Care Consultants Research	St. Louis	Missouri
United States	Washington University in St. Louis	St. Louis	Missouri
United States	Psychiatric Recovery	St. Paul	Minnesota
United States	SUNY UMU at Syracuse	Syracuse	New York
United States	University of Arizona	Tucson	Arizona
United States	Valdosta Psychiatric Associates LLC	Valdosta	Georgia
United States	Dupage Mental Health Services	Wheaton	Illinois
United States	Clinical Research Institute	Wichita	Kansas
United States	Wake Forest University - Health Sciences	Winston Salem	North Carolina
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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, Müller-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS)	Recurrence based on MADRS is defined as first time attained MADRS total score = 20 after achieving remission. Remission is a binary outcome response variable (Yes/No in-remission) defined as MADRS total score Time-to-event analyses were summarized using Kaplan-Meier curves. Patients who did not achieve recurrence at the end of the study were censored on the last visit date recorded. Additionally, patients who discontinued early were censored on last date of contact. Censored observations and confidence intervals for the estimated median times were calculated.	3-Month Through 60-Month (Post Baseline)	No
Secondary	Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score =9 at Visit Month Assessment Post-Baseline)	Remission is a binary outcome response variable (Yes/No Inremission) defined as MADRS total score < 9 at visit month assessment post-baseline. 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 and in general it is accepted that a score between 0-6 is indicative of a normal/symptom-free individual; 7-19 is indicative of a patient with mild depression; 20-34 is indicative of a patient with moderate depression; and >34 is indicative of a patient with severe depression. 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)	No
Secondary	Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation	This assessment was completed telephonically by a third party rater (Central Rater Group). The rating was based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones, which allowed a precise rating of severity. The rater decided whether the rating lied on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5) and then checked the appropriate selection on the MADRS Item 10 Suicidal Thoughts (Ideation).; Total number of patients analyzed may be lower than ITT in a case of missing assessment data.	1 Week Pre-Baseline	No
Secondary	Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture	This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's medical threat to life of their most recent suicidal gesture or attempt.; Total number of patients analyzed may be lower than ITT in a case of missing assessment data.	Baseline	No
Secondary	Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture	This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's intent of their most recent suicidal gesture or attempt.; Total number of patients analyzed may be lower than ITT in a case of missing assessment data.	Baseline	No
Secondary	Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE	This assessment was completed by the physician at the screening visit. The physician decided which DSM-IV Diagnosis (as shown in outcome measure data table) best characterized the patient's primary diagnosis of MDE.	Screening	No