Treatment-Resistant Depression Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00320372 |
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Recruitment Status :
Completed
First Posted : May 3, 2006
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
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| Condition or disease |
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| Major Depressive Disorder |
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.
| Study Type : | Observational |
| Actual Enrollment : | 795 participants |
| Time Perspective: | Prospective |
| 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. |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | May 2015 |
| Group/Cohort |
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1. 500 VNS Patients
VNS Patients - Treatment-resistant depression patients treated with VNS Therapy.
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2. 300 Non-VNS Patients
Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy.
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- Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline) [ Time Frame: 3-Month Through 60-Month (Post 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.
- Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 3-Month Through 60-Month (Post Baseline) ]
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 </= 9 at visit month assessment post-baseline. Duration of remission Computed as recorded date of the first recurrence/relapse (MADRS score >/= 20) minus the recorded date of first achieved remission (MADRS score </=9). Only a subpopulation that achieved remission will be included in the summary.
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.
- Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline) [ Time Frame: 3-Month Through 60-Month (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.
- Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation [ Time Frame: 1 Week Pre-Baseline ]
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.
- Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture [ Time Frame: Baseline ]
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.
- Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture [ Time Frame: Baseline ]
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.
- Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE [ Time Frame: Screening ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320372
Show 55 study locations
| Principal Investigator: | 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 | NorthShore University HealthSystem | |
| 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 | |
| Study Director: | Mark Bunker | Cyberonics, Inc. | |
| Principal Investigator: | 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cyberonics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00320372 |
| Obsolete Identifiers: | NCT00657215 |
| Other Study ID Numbers: |
TRD Registry |
| First Posted: | May 3, 2006 Key Record Dates |
| Results First Posted: | December 23, 2015 |
| Last Update Posted: | December 23, 2015 |
| Last Verified: | December 2015 |
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Major Depressive Disorder Treatment-resistant Depression |
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Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant |
Behavioral Symptoms Mood Disorders Mental Disorders |