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.
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.
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.
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Time Perspective: Prospective
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