Results Of Brodmann Area 25 Deep Brain Stimulation Pilot Study Offer Hope For Patients With Severe Depression
Results of the study, which were presented at the American Psychiatric Association (APA) meeting in Washington, D.C., found that 6 months after the procedure, 56 percent of the patients experienced at least a 40 percent decrease in depressive symptoms. Patient's symptoms were measured using a standardized test called the Hamilton Rating Scale for Depression.
Results were presented by Sidney Kennedy, M.D., psychiatrist-in-chief with the University Health Network in Toronto. "Severe depression destroys a person's ability to be productive and have a normal quality of life," said Dr. Kennedy. "The results from this study are very promising, and we are hopeful that our research will lead to a therapy that can help these patients."
Prior to beginning the study, all patients were classified as having severe depression after multiple treatments - such as medications, psychotherapy and electroconvulsive therapy - had failed to provide sustained relief from depression. Each study patient had tried a minimum of 12 depression medications over his or her lifetime.
DBS was targeted at an area of the brain known as Brodmann Area 25, which appears to become overactive when people are profoundly sad and depressed. Conducted at three leading Canadian academic medical centers, the study expands and supports the groundbreaking research of Helen Mayberg, M.D., and Andres Lozano, M.D., which was published in Neuron in March 2005.
On average, the 20 study participants had suffered from depression for more than 20 years; they were disabled and unable to work at the time of enrollment. The study also found that:
-- At their most recent psychiatric evaluation, 78 percent of the patients experienced at least a 40 percent decrease in depressive symptoms.
-- Three of the study patients are considered to be in remission.
-- Eight patients have re-engaged in life activities such as work, school, relationships and travel.
In the study, DBS was delivered through the St. Jude Medical Libra(R) Deep Brain Stimulation System, which delivers mild electrical current from a device implanted near the collarbone; the device is connected to small electrical leads placed at specific targets in the brain.
"These results are important as they help establish the body of evidence that will continue to move depression research forward," said Chris Chavez, president of the St. Jude Medical ANS Division. "We are committed to leading the development of products that can make life better for patients suffering from this debilitating condition."
Based on the results of this research, St. Jude Medical announced the BROADEN(TM) (BROdmann Area 25 DEep brain Neuromodulation) study in February 2008, to further investigate the use of DBS for major depressive disorder. A controlled, multi-center, blinded clinical study, BROADEN is being conducted in the U.S. under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).
St. Jude Medical owns the intellectual property rights and has various patents issued and pending for the use of neurostimulation at Brodmann Area 25. For more information about this clinical trial, call toll-free 866-787-4332 or visit http://www.BROADENstudy.com.
According to the National Advisory Mental Health Council, of the 21 million adult Americans who suffer from depression, approximately 4 million live with severe depression that does not respond to medications, psychotherapy and, in certain cases, electroconvulsive therapy.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,000 people worldwide. For more information, please visit http://www.sjm.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 (http://www.ans-medical.com).
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's Annual Report on Form 10-K filed on February 27, 2008 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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