NCT00320372

Treatment-Resistant Depression Registry

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 795 (actual)
• Sponsor: Cyberonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Major Depressive Disorder

Timeline

• Start date: 2006-01-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2006-05-03
• Last updated: 2015-12-23
• Results posted: 2015-12-23

Locations

55 sites across 1 country: United States