NCT02586688

Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Neuronetics · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).

Detailed description

To evaluate the antidepressant effects of daily, active TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode. Secondary: To evaluate the acute and long term safety of TMS treatment in adolescent MDD subjects. To evaluate the durability of benefit of TMS treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) . To evaluate the benefit of daily, active, open-label TMS in Phase I subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) .

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Active NeuroStar® Transcranial Magnetic Stimulation (TMS)	Compare active NeuroStar® coil with sham NeuroStar® coil.
DEVICE	Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)	Compare active NeuroStar® coil with sham NeuroStar® coil.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-01-01
• Completion: 2018-12-01
• First posted: 2015-10-26
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

13 sites across 1 country: United States