Patients in St. Jude Medical Deep Brain Stimulation for Depression Pilot Study Demonstrate Sustained Improvement in Depressio...
May 18 2009 - 6:00PM
Business Wire
According to the latest data in a clinical study supported by
St. Jude Medical, Inc. (NYSE:STJ), deep brain stimulation (DBS)
therapy for depression may provide sustainable improvement in
depression symptoms among patients with major depressive disorder.
Study results will be presented today at the American Psychiatric
Association (APA) meeting in San Francisco.
This study profiles 21 patients with DBS therapy in the area of
the brain known as Brodmann Area 25, most of whom have completed
one year of post-surgery evaluation. At six months, 62 percent of
the patients experienced at least a 40-percent decrease in symptoms
of depression as measured by a standardized test called the
Hamilton Rating Scale for Depression. Of these patients, 92 percent
maintained this improvement at their last follow-up visit
(typically at one year). Additionally, 71 percent of all patients
in the study exhibited at least a 40-percent decrease in symptoms
of depression as measured by the Hamilton scale.
�Typically these patients do not maintain responses to
traditional approaches such as medications and electroconvulsive
therapy,� said Peter Giacobbe, M.D., psychiatrist with the
University Health Network in Toronto and presenter of the study
results. �We are encouraged that this data indicates DBS therapy
may provide sustainable improvement in the quality of life for
these patients.�
Ongoing at three leading Canadian academic medical centers, the
study utilizes the St. Jude Medical Libra� Deep Brain Stimulation
System to deliver stimulation to an area of the brain known as
Brodmann Area 25, which appears to become overactive in severely
depressed people. The pilot study builds upon the research of Helen
Mayberg, M.D., and Andres Lozano, M.D.
Patients in the study had suffered from depression for an
average of 20 years, had tried in excess of 12 depression
medications and were considered disabled or unable to work at the
time of enrollment. At the 12-month evaluation point, eight of the
study patients had returned to daily life activities such as
school, work and sustaining relationships with family and friends,
and two patients were considered to be in remission.
�These results are important as they contribute to the growing
body of research about the potential benefits deep brain
stimulation may provide this patient population,� said Chris
Chavez, president of the St. Jude Medical Neuromodulation Division.
�We are committed to expanding our research into the field of
depression and to completing�the BROADEN� study to determine
whether stimulation of Brodmann Area 25 is clinically significant
in�treating severely depressed patients who have exhausted other
treatment options."
The early results of the Brodmann Area 25 pilot study led to the
establishment of the BROADEN (BROdmann Area 25
DEep brain Neuromodulation) study, a larger
controlled, blinded pivotal study. The BROADEN study is being
conducted under a U.S. Food and Drug Administration (FDA)
Investigational Device Exemption (IDE). For more information about
this clinical study, call toll-free 866-787-4332 or visit
www.BROADENstudy.com.
An estimated 21 million adult Americans suffer from depression
according to the National Mental Health Advisory Council. Of these,
approximately 4 million live with severe depression that does not
respond to medications, psychotherapy and, in certain cases,
electroconvulsive therapy.
The Libra Deep Brain Stimulation System is currently approved in
Europe for the symptomatic treatment of Parkinson�s disease. St.
Jude Medical has clinical studies underway in the U.S. for
Parkinson�s disease and essential tremor. More than 45,000 patients
in 35 countries have been implanted with St. Jude Medical
neurostimulation systems. For more information about St. Jude
Medical pain therapies, visit www.PowerOverYourPain.com.
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. Headquartered in St. Paul, Minn., St.
Jude Medical employs approximately 14,000 people worldwide and has
four major focus areas that include: cardiac rhythm management,
atrial fibrillation, cardiovascular and neuromodulation. For more
information, please visit www.sjm.com.
Forward-Looking Statements
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 Risk Factors and Cautionary Statements sections of the
Company�s Quarterly Report on Form 10-Q for the fiscal quarter
ended April 4, 2009. 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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