Nov. 22, 2004 CHICAGO -- Psychiatrists at Rush University Medical Center are testing a noninvasive technique that uses repeated short bursts of magnetic energy to stimulate nerve cells in the brain to treat major depression. The therapy is called Transcranial Magnetic Stimulation (TMS), and Rush is enrolling patients in a clinical trial to determine if TMS is safe and effective.
"We think that this is landmark research for a new antidepressant treatment," said Dr. Philip Janicak, Rush psychiatrist and the principal investigator for the study at Rush. "If proven effective, TMS could signal a radical shift in our approach to treating major depression." Depression is commonly treated with antidepressants and other pharmaceuticals, psychotherapy and electroconvulsive therapy (ECT) for severe cases when patients do not respond to other therapies.
This study focuses on patients who have not responded to antidepressant medication for their depression. Rush is one of 16 academic medical centers participating in this nationwide clinical trial. Smaller preliminary studies using TMS produced an antidepressant effect and led to the current research project. Information from this larger, more rigorous trial will be provided to the U.S. Food and Drug Administration to support regulatory clearance of the Neuronetics TMS System for use in treating depression.
The double-blind study will test the new treatment while controlling for this so-called "placebo effect." Janicak explained that this study, which includes a placebo (or sham) treatment, is needed because some patients improve simply due to the added attention they receive in a research study. Neither the doctor nor the patient will know which treatment, the active TMS or the placebo, is being used. After the initial treatment phase (four to six weeks), however, patients can be given the real TMS treatment if their symptoms have not improved.
Transcranial magnetic stimulation (TMS) produces pulses of magnetic energy that are aimed at a specific portion of the brain, the left prefrontal cortex. Researchers believe the left prefrontal cortex is involved in regulating mood.
TMS produces the same amount of magnetic energy as a standard MRI machine. However, instead of helping doctors look inside the body to diagnose disease, the pulses of magnetic energy produce an electric field that researchers believe causes positive changes in mood.
"The amount of energy delivered to the brain is very small and very focused," Janicak said. Patients remain fully awake during the 45-minute outpatient procedure and can go about their normal activity before and after the procedure. TMS is performed without anesthesia, and it does not cause memory loss as is sometimes found with the use of ECT. Patients who qualify for the trial will initially receive 30 sessions over a period of six weeks.
The National Institute of Mental Health reports that depression affects more than 18 million adults every year. Even with recent advances in antidepressant medications, a significant percentage of patients experience treatment-resistant or recurrent episodes of depression. Some patients cannot tolerate medications.
This new research study, which involves hundreds of patients nationwide, will be a pivotal trial. If the results of the study are positive and the TMS procedure is approved by the U.S. FDA, an entirely new treatment option for patients suffering from depression would be available.
Rush is inviting qualified patients to volunteer to participate in this study. To qualify, patients must be:
* between 18 and 70 years old. * suffering from a major depressive disorder. * able to provide written documentation that they have been unsuccessfully treated previously with antidepressant medication.
Patients who have been diagnosed with bipolar illness (manic depression) or obsessive-compulsive disorder are not eligible to participate in the trial.
For more information or to volunteer, call 1-800-345-8707.
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