St. Jude Medical Announces Clinical Study Of Deep Brain Stimulation For Depression
St. Paul, MN - St. Jude Medical, Inc. recently announced it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in a controlled, multi-site, blinded, clinical study of deep brain stimulation for major depressive disorder, a severe form of depression.
The BROADEN (BROdmann Area 25 DEep brain Neuromodulation) study will evaluate the safety and effectiveness of deep brain stimulation in patients with depression for whom currently-available treatments are not effective. The study will build upon the pioneering depression work of a research team from the University of Toronto, led by neurologist Helen S. Mayberg, M.D. (now with Emory University School of Medicine), and neurosurgeon Andres Lozano, M.D.
"Major depressive disorder is severely disabling," said Dr. Lozano. "Currently, there are no widely-accepted treatment options for patients with this condition once multiple medications, psychotherapy and electroconvulsive therapy have failed."
Drs. Mayberg and Lozano conducted the first study of deep brain stimulation (DBS) for depression in Toronto, Canada, in 2003 and published their findings in Neuron in March 2005. As reported in this journal article, imaging studies led them to an area of the brain thought to be involved in depression called Brodmann Area 25. This area appears to become overactive when people are profoundly sad and depressed.
St. Jude Medical owns the intellectual property rights and has various patents pending for the use of neurostimulation at Brodmann Area 25. The Libra® Deep Brain Stimulation System, which is being evaluated in this study, is designed to deliver mild electrical pulses from a device implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain.
In the U.S., more than 21 million adults suffer from some kind of depressive disorder, according to the National Institute of Mental Health. Of these, only about 80 percent can be effectively treated with currently available therapies, according to the National Advisory Mental Health Council. Unfortunately, that means approximately 4 million adult Americans live with depression that does not respond to medications, psychotherapy and, in certain cases, electroconvulsive therapy.
"St. Jude Medical is dedicated to researching and developing neuromodulation therapies for people who live with conditions such as severe depression," said Chris Chavez, president of St. Jude Medical's ANS Division. "We are hopeful that this trial will lead to the successful development of a sustainable therapy for those patients who have exhausted other treatment options."
To be eligible for the study, participants must:
- Currently be diagnosed with major depressive disorder
- Be between 21 and 70 years old, with onset of first episode before age 45
- Have tried at least four treatments in their current episode, such as different medications, various combinations of medications or electroconvulsive therapy
- Have been depressed for at least one year
For more information about this study, call toll-free 866-787-4332 or visit www.BROADENstudy.com.
About the ANS Division of St. Jude Medical
The ANS Division (Advanced Neuromodulation Systems) became a part of St. Jude Medical in 2005. The ANS Division is an innovative technology leader dedicated to the design, development, manufacturing and marketing of implantable neuromodulation systems to improve the quality of life for people suffering from disabling chronic pain and other nervous system disorders (www.ans-medical.com).
SOURCE: St. Jude Medical, Inc.