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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Depression

Trial Information

Treatment-Resistant Depression Registry

Depression is a mood disorder that can have profound personal, social, and financial implications. Depression is recurrent for most patients and chronic for many others. Vagus Nerve Stimulation (VNS) Therapy is FDA approved for the treatment of chronic or recurrent depression for patients who have not had an adequate response to four or more standard antidepressant treatments.

Patients that have been offered VNS therapy qualify to participate in this observational registry. The registry will collect information about subjects with treatment-resistant depression, including response to treatments, quality of life, and use of healthcare services. Those subjects who plan to be treated with VNS Therapy will provide the date of surgical evaluation and/or surgical implantation and will be followed for 5 years from that date. Subjects who decide not to go through with the procedure will be randomly assigned to be followed for either 2 or 5 years as controls. An initial evaluation will be preformed using questionnaires concerning the subject's medical and psychiatric history. Once enrolled in the study, subjects will be tracked for 2-5 years. Follow up visits or phone calls will require subjects to answer questions concerning health, depression, and treatment for depression 4 times for the first year and 2 times a year for the next 1-4 years.

Subjects will be paid $50 for each completed registry visit and telephone call for a total of $700 for completion of the entire study. It is important to note that Cedars-Sinai does not provide VNS therapy nor does it provide funding to subjects wishing to receive this treatment.

Patient Inclusion Criteria:

• Subject experiencing current major depressive episode
• Subject has been in their current depressive episode for two years or longer, or has had at least three lifetime episodes including current episode
• Subject has had inadequate response to four or more adequate antidepressant treatments
• Subject is 18 years of age or older

Patient Exclusion Criteria:

• Subject has history of schizophrenia, schizoaffective disorder, and other psychotic disorder, or a current major depressive episode that includes psychotic features
• Subject currently enrolled in a double-blind investigational study
• Subject has already received VNS Therapy
• Subject has history of rapid cycling bipolar disorder

Lindsay Crist, Study Coordinator
Cedars-Sinai Medical Center
8730 Alden Dr. Room E123
Los Angeles, CA 90048
Phone: 310-423-6515
Fax: 310-423-0888
EMail: Lindsay.Crist@cshs.org

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