"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.