Expanded use warranted?
The intervention proved very safe. Side effects, including headaches, were minimal, and there were “virtually no cognitive effects,” said Dr. Sackeim.
Dr. Sackeim believes TMS, as it has evolved, “is an outstanding option for treatment-resistant depression, and it has a very bright future” and should not be reserved for patients with established treatment-resistant depression (TRD), which is the current U.S. Food and Drug Administration indication.
“Restricting it to TRD in my mind is probably a mistake. Why shouldn’t the patient who is just starting on their course of treatment for depression have this as a nonpharmacological option?” he said.
Limitations of the study included its open-label design and the fact that only patients’ age, gender, outcome scores, and TMS treatment parameters were recorded in the registry. Other clinical characteristics, including medication use, were unknown.
However, it’s presumed that most patients had TRD, because insurance reimbursement for TMS typically requires an extensive history of failed antidepressant treatment.
Commenting on the study for an interview, Mark George, MD, professor, and Layton McCurdy, endowed chair in psychiatry, the Medical University of South Carolina, Charleston, called the remission and response rates “remarkable.”
Dr. Mark George
The study included a “huge sample size” of Americans suffering from depression “who have not responded to talking therapy or medications,” noted Dr. George.
“This real-world study shows how effective, safe, and important TMS is for depressed patients who do not respond to medications,” he said.
Neuronetics supported the NeuroStar Advanced Therapy System Clinical Outcomes Registry, analysis of the registry data, and the drafting of this manuscript. Dr. Sackeim serves as a scientific adviser to LivaNova PLC, MECTA Corporation, and Neuronetics. He receives honoraria and royalties from Elsevier and Oxford University Press. He is the inventor on nonremunerative U.S. patents for Focal Electrically Administered Seizure Therapy (FEAST), titration in the current domain in ECT, and the adjustment of current in ECT devices; each patent is held by the MECTA Corporation. He is also the originator of magnetic seizure therapy.
A version of this article first appeared on Medscape.com.