Status:
COMPLETED
Treatment-Resistant Depression Registry
Lead Sponsor:
Cyberonics, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
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 on...
Detailed 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 Re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
795 Patients enrolled
Trial Details
Trial ID
NCT00320372
Start Date
January 1 2006
End Date
May 1 2015
Last Update
December 23 2015
Active Locations (55)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Cedars-Sinai Hospital
Beverly Hills, California, United States
3
Mark Zetin, MD - Private Practice
Garden Grove, California, United States, 92840
4
Loma Linda University
Loma Linda, California, United States