Deep brain stimulation improves symptoms of patients with depression
10 June 2009
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.
Results of the study results were presented at the American
Psychiatric Association (APA) meeting last month.
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% of the patients experienced
at least a 40% decrease in symptoms of depression as measured by a
standardized test called the Hamilton Rating Scale for Depression.
Of these patients, 92% maintained this improvement at their last
follow-up visit (typically at one year). Additionally, 71% of all
patients in the study exhibited at least a 40% 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, MD, 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, MD, and Andres
Lozano, MD.
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 US Food and Drug Administration
(FDA) Investigational Device Exemption (IDE).
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 US for Parkinson’s disease
and essential tremor. More than 45,000 patients in 35 countries have
been implanted with St Jude Medical neurostimulation systems.
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