St. Jude Medical Study Results Confirm Benefit of Treating Patients Suffering from Severe Depression with Deep Brain Stimulat...
November 18 2011 - 10:30AM
Business Wire
Results from the first multi-center pilot study of deep brain
stimulation (DBS) for major depressive disorder were published
online today by the Journal of Neurosurgery. The study, conducted
at three research facilities in Canada, was designed to replicate
and build upon an earlier study by Dr. Andres Lozano and Dr. Helen
Mayberg which was published in the journal Neuron in 2005.
Sponsored by St. Jude Medical, Inc. (NYSE:STJ), the study
demonstrates significant improvement in depression symptoms among
patients who are highly treatment resistant.
The results of the study showed that DBS therapy targeted to an
area of the brain known as Brodmann Area 25 provided noticeable
improvement in depression symptoms and increased overall quality of
life in patients who typically don’t respond to treatment. The
study enrolled 21 patients who on average had suffered from
depression for 20 years, had tried in excess of 16 depression
medications and were considered disabled or unable to work at the
time of enrollment.
At one year, 62 percent of all patients in the study had a
40-percent reduction in symptoms and 29 percent experienced a
50-percent reduction in symptoms as measured against their baseline
which was established using the Hamilton Rating Scale for
Depression.
“The reduction in depression scores is clinically significant as
these patients had previously tried multiple medications,
psychotherapy and/or electroconvulsive therapy (ECT) without
success,” said Dr. Andres Lozano, neurosurgeon at Toronto Western
Hospital, author of the paper and a primary investigator in the
study. “To see 62 percent of the patients in this study respond at
one year gives us hope that this research may lead to a therapy for
this hard-to-treat patient population.”
Patients in the study were also evaluated using a Clinical
Global Impression of Severity (CGI-S) rating scale that measures
the severity of their illness. Before DBS, 70 percent of the
patients were categorized as severely or extremely ill. After 12
months of DBS, over 80 percent of the patients experienced
improvement and none of the patients were rated as severely or
extremely ill.
Additionally, study results announced earlier at the American
Psychiatric Association annual meeting reported that eight of the
study patients returned to daily life activities such as work,
school and sustaining relationships with family and friends, and
two patients were considered to be in remission.
Participants in the St. Jude Medical-sponsored study featured in
the Journal of Neurosurgery were implanted with the Libra™ DBS
system which delivers mild pulses of current from a device
implanted near the collarbone to small electrical leads placed in
the subcallosal cingulate (SCC) area of the brain, a structure
within Brodmann Area 25.
“These findings are significant as they confirm the basis on
which we established the BROADEN pivotal study,” said Rohan Hoare,
president of St. Jude Medical Neuromodulation Division. “These
results add to the growing evidence suggesting that DBS therapy may
help patients who currently don’t have an adequate treatment option
in managing severe depression.”
St. Jude Medical is currently conducting a large multi-center
pivotal study at up to 20 facilities in the U.S. and
internationally under a U.S. Food and Drug Administration (FDA)
Investigational Device Exemption. To be eligible for the BROADEN™
study, participants must:
- Have been diagnosed with major
depressive disorder
- Be between 21 and 70 years old
- Have had first depressive episode
before age 45
- Have tried at least four treatments in
their current episode (for example, different medications,
different combinations of medications, and/or ECT)
To locate participating centers, please visit
www.BROADENstudy.com or call toll-free 866-787-4332.
According to the Journal of Neurosurgery article, the most
frequently occurring serious adverse events related to DBS were
skin erosion and lead extension malfunction.
Depression affects millions of patients worldwide with more than
21 million adults in the U.S. suffering from some kind of
depressive disorder, according to the National Institute of Mental
Health. Of these, approximately 4 million live with severe
depression that does not respond to traditional treatments such as
medications, psychotherapy and ECT.
Three Decades of Leading-Edge Neurostimulation
Technology
For more than 30 years, St. Jude Medical Neuromodulation
Division has developed new technologies to treat chronic pain and
other neurological disorders. Today more than 75,000 patients in 40
countries have been implanted with St. Jude Medical
neurostimulation systems. Focused on research, St. Jude Medical is
developing new technologies to address a growing list of
neurological disorders. Clinical studies are currently underway for
Parkinson’s disease, essential tremor, migraine headache, and
others.
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. St. Jude Medical is headquartered in
St. Paul, Minn., and has four major focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit 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 Annual Report on Form 10-K for the fiscal year ended
January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 2, 2011. 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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