Non-Invasive Treatment For Depression - Rush University Medical Center Psychiatrist Led Clinical Trials Of Transcranial Magnetic Stimulation

Main Category: Depression
Also Included In: Regulatory Affairs / Drug Approvals;  Psychology / Psychiatry
Article Date: 10 Oct 2008 - 2:00 PDT

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Transcranial Magnetic Stimulation (TMS) therapy has received clearance from the U.S. Food and Drug Administration (FDA) and is now an entirely new treatment option for patients suffering from depression.

Dr. Phil Janicak, a professor of psychiatry at Rush University Medical Center, was the principal investigator for the clinical trials of TMS, which is a system that uses repeated short bursts of magnetic energy introduced through the scalp to stimulate nerve cells in the brain to alleviate major depression.

TMS therapy, which is developed by Neuronetics, Inc., is an effective, non-drug treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from antidepressant medication.

"In the randomized, controlled trial conducted for FDA clearance, TMS Therapy demonstrated statistically and clinically significant treatment effects," said Dr. Janicak. "It's particularly noteworthy that these outcomes were achieved without systemic side effects, such as weight gain and sexual dysfunction."

TMS therapy was evaluated for efficacy, safety and tolerability in the acute treatment of major depression in patients who had failed to receive benefit from prior antidepressant medications. Throughout the study, more than 10,000 active TMS treatment sessions were safely performed. There were no systemic side effects such as weight gain, sexual dysfunction, sedation, nausea or dry mouth. There were no adverse memory effects, seizures or device-drug interactions. Overall, less than five percent of patients discontinued the study due to adverse events. Also, during the six-month follow-up period, there were no new safety issues compared with those seen during the acute treatment phase.

Patients treated with TMS therapy do not require anesthesia or sedation and remain awake and alert. It is a 40-minute outpatient procedure that is prescribed by a psychiatrist and performed in an outpatient setting. The treatment is typically administered daily for four-to-six-weeks.

Depression affects at least 14 million American adults each year. Researchers estimate that by the year 2020, depression will be the second leading cause of disability worldwide. About two-thirds of those who experience an episode of depression will have at least one other episode in their lives. Depression is a debilitating illness, and existing treatment options are frequently ineffective or intolerable due to side effects. Current antidepressant therapies are not beneficial for at least a third of depressed individuals, leaving many with a lack of adequate treatment options.

"Before now, few options have been available for them other than complex and often unproven combinations of medications," said Dr. Janicak. "Now, with the FDA clearance of NeuroStar TMS Therapy, there is new hope."

RUSH