NCT05541302

Retrospective TMS Therapy for Adults With MDD

A Retrospective Registry Study to Evaluate Extended NeuroStar® TMS Therapy for Adults With Major Depressive Disorder (MDD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,456 (actual)
• Sponsor: Neuronetics · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.

Detailed description

The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DEVICE	TMS	Transcranial Magnetic Stimulation

Timeline

• Start date: 2008-11-01
• Primary completion: 2022-08-30
• Completion: 2022-08-31
• First posted: 2022-09-15
• Last updated: 2022-09-15

Regulatory

• FDA-regulated device study