Purpose

This is a postmarket medical device study. The objective of this study is to compare the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy administered at different amounts of electrical charge for the treatment of patients with treatment-resistant depression (TRD).

Type of Study: Clinical Trial
Setting of Study: outpatient
Clinical Trials.gov number: NCT00305565
Providing Clinical Treatment?: Yes
No Cost Treatment?: No

Study Activities

Filling Out Forms
Provides Payment: Reimbursement for transportation
Provides Payment: Compensation for study related procedures

Eligibility

Ages Eligible for Study: 18 Years - 90 Years
Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.

Criteria

Inclusion Criteria:
* Patient has a diagnosis of chronic or recurrent depression and is currently experiencing a major depressive episode.
* Patient has not had an adequate response to four or more adequate antidepressant treatments from at least two different antidepressant treatment categories.
* Patient has (in the investigator’s judgment) sufficient impairment from his/her depression and/or depression treatment that the potential benefits/risks of VNS Therapy are warranted.
* Patient must currently be receiving at least one antidepressant treatment; the patient must be receiving all current antidepressant treatments in a stable regimen.
* If the patient has a current diagnosis of bipolar disorder, the patient must be receiving a mood stabilizer.
* Patient must be 18 years of age or older and of legal age of consent.
* Patient must be able to complete the evaluations specified in the study procedures flow chart.
* Patient must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Location: Division of Brain Stimulation and Therapeutic Modulation Brain Behavior Clinic New York State Psychiatric Institute 1051 Riverside Drive, Unit 21 New York, NY 10032
Clinic: Novel Treatments for Depression Service
Division: Neuroscience

Study chairs or principal investigators:
Sarah Hollingsworth Lisanby MD, Principal Investigator

Co-investigators:
Antonio Mantovani,
Alexandra Sporn,