NeuroStar® Advanced Therapy System is an effective acute treatment for patients with major depressive disorder (MDD). To further understand the efficacy of the NeuroStar in a clinical setting, Neuronetics has established the largest patient treatment and outcomes registry for Major Depressive Disorder (MDD) to collect and analyze the efficacy of transcranial magnetic stimulation (TMS) on patients receiving NeuroStar treatment.

Individual NeuroStar providers are invited to participate in the registry and over 100 clinical practice sites have agreed to provide their de-identified patient treatment data. An integrated electronic data management system (TrakStar) allows for large-scale data collection to be automated. The data collected for the registry include Demographic Elements (age, gender), Treatment Parameters, and Clinical Ratings. Clinical assessments performed at baseline and the end of acute treatment are the Patient Health Questionnaire 9-item (PHQ-9) and the Clinician Global Impression - Severity of Illness (CGI-S). De-identified patient data is uploaded to a Registry server; an independent statistical service then creates final data reports.

Over 3300 evaluable patients have entered the NeuroStar Outcomes Registry since September 2016. The population is 64% female with a mean patient age of 47.8 (SD±16.9); Mean baseline PHQ-9 is 19.0 (SD±5.0). Response & remission rate on PHQ-9 is 63% & 33%, and on CGI-S was 76% & 54%, respectively.

For the over 3300 patients in the Outcomes Registry, approximately 2/3 patients achieve response and 1/3 patients achieve remission with an acute course of NeuroStar TMS. These treatment outcomes are consistent with previous open-label study data (Carpenter et al., 2012) using the NeuroStar system. The NeuroStar Outcomes Registry is ongoing and has surpassed Star*D dataset (Rush et al., 2006) with over 3300 evaluable patients from more than 100 clinical sites in 3 years.

Funding: Neuronetics, Inc.