Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cyberonics, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Treatment-Resistant Depression Registry
