At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Parallel-Group, Sham-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of the Neuronetics Model 2100 CRS Repetitive Transcranial Magnetic Stimulation (rTMS) System in Patients With Major Depression
In Brief
A Phase 3 clinical trial evaluating Repetitive Transcranial Magnetic Stimulation for Major Depressive Disorder. Completed, enrolled 286 participants across 13 sites.
Detailed Summary
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect. It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in both academic and private research centers. It is comprised of three major phases: pre-study screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to one of two rTMS treatment groups. One group will receive active rTMS treatment and one will receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on an outpatient basis. All trial related medical care is provided at no cost to the participant.