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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