Study Comparing Outcomes for Patients With Treatment Resistant Depression Who Receive VNS Therapy at Different Doses

Completed · Phase 4

Conditions studied: Depression

In brief

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).

Key facts

Study ID

NCT00305565

Run by

Cyberonics, Inc.

People needed

331

Starts

2006-01-01

Expected to finish

2010-02-01

Last updated by the study team

2014-01-07

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• Patient has had a bilateral or left cervical vagotomy.
• Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
• A VNS Therapy System implant would pose an unacceptable surgical or medical risk for the patient.
• Patient is expected to require full body magnetic resonance imaging during the clinical study.
• Patient is acutely suicidal.
• Patient has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression).
• Patient has a history of rapid cycling bipolar disorder or a current diagnosis of bipolar disorder mixed phase.
• Patient has a history of borderline personality disorder.
• Patient has a history of drug or alcohol dependence within the 12 months prior to the baseline visit or currently takes a narcotic drug five or more days per week.
• Patient is currently enrolled in another investigational study.
• Patient has had a prior VNS Therapy System implant.
• Note: Some IRBs may require additional conditions for enrollment.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• Northwest Behavioral Research Center — Marietta, Georgia, United States
• Evanston Northwestern Hospital — Evanston, Illinois, United States
• Clinical Research Institute — Wichita, Kansas, United States
• Brentwood Research Institute — Shreveport, Louisiana, United States
• Sheppard Pratt Hospital — Baltimore, Maryland, United States
• Pharmasite Research Inc. — Baltimore, Maryland, United States
• Massachusetts General Hospital — Charlestown, Massachusetts, United States
• Psychiatric Recovery — Saint Paul, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Dent Neurologic Institute — Amherst, New York, United States
• Eastside Comprehensive Medical Center — New York, New York, United States
• New York State Psychiatric Institute — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Butler Hospital — Providence, Rhode Island, United States
• Community Clinical Research, Inc. — Austin, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Claghorn-Lesem Research Clinic, LTD — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.