(photo credit: Courtesy)
Newswise — ST. PAUL, Minn., – Nov. 18, 2011 – 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.
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.
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
“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.”This article was first published at: www.newswise.com