Treatment-Resistant Depression Registry

Completed

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID: NCT00320372
Run by: Cyberonics, Inc.
People needed: 795
Starts: 2006-01-01
Expected to finish: 2015-05-01
Last updated by the study team: 2015-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

Cedars-Sinai Hospital — Beverly Hills, California, United States
Mark Zetin, MD - Private Practice — Garden Grove, California, United States
Loma Linda University — Loma Linda, California, United States
Sutter Institute for Medical Research — Sacramento, California, United States
Fair Oaks Psychiatric Associates — Sacramento, California, United States
University of Connecticut Health Center — Farmington, Connecticut, United States
Florida Atlantic University — Boca Raton, Florida, United States
University of Florida — Gainesville, Florida, United States
MG Martelli, MD, PC and Associates — Brunswick, Georgia, United States
Arthur Holt, Private Practice — Columbus, Georgia, United States
Pact Atlanta, LLC — Decatur, Georgia, United States
Private Practice — Macon, Georgia, United States
Northwest Behavioral Research Center — Marietta, Georgia, United States
Valdosta Psychiatric Associates LLC — Valdosta, Georgia, United States
Northshore University Health System — Evanston, Illinois, United States
McGrath Clinic — Evergreen Park, Illinois, United States
Alexian Brothers Behavioral Health Hospital — Hoffman Estates, Illinois, United States
Psychiatric Medicine Associates, LLC — Skokie, Illinois, United States
Dupage Mental Health Services — Wheaton, Illinois, United States
3c Methodist Hospital — Indianapolis, Indiana, United States
Clinical Research Institute — Wichita, Kansas, United States
Louisiana Clinical Research, LLC — Shreveport, Louisiana, United States
Pharmasite Research Inc. — Baltimore, Maryland, United States
Sheppard Pratt Health Systems, Inc. — Baltimore, Maryland, United States
University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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