Treatment-Resistant Depression Registry

Cyberonics

Status: Completed

Conditions: Major Depressive Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT00320372

TRD Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 795 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

795 participants in 2 patient groups

1. 500 VNS Patients

Description:

VNS Patients - Treatment-resistant depression patients treated with VNS Therapy.

2. 300 Non-VNS Patients

Description:

Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy.