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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
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.
Rush University Medical Center
Chicago, Illinois, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
Premier Psychiatric Group, L.L.C.
Lincoln, Nebraska, United States
Butler Hospital
Providence, Rhode Island, United States
Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.
Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.
Time frame: 12 month evaluation
Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.
Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures.
Time frame: 12 Month evaluation
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Medical University of South Carolina
Charleston, South Carolina, United States
Center for Anxiety and Depression
Mercer Island, Washington, United States