NCT01415154

Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Neuronetics · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic worsening in patients who have shown a clinical response to acute TMS treatment.

Detailed description

This is a 12-month maintenance treatment study for patients who have responded to a 6 week course of acute TMS treatment for major depressive disorder (MDD). The study will seek to assess the change in depressive symptomatology across the duration of maintenance treatment using observer and self-administered efficacy measures. Describe the efficacy of TMS re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by maintenance TMS treatment for up to 12 months.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	NeuroStar TMS	NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-09-01
• Completion: 2014-07-01
• First posted: 2011-08-11
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study