Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect.
It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in both academic and private research centers. It is comprised of three major phases: pre-study screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to one of two rTMS treatment groups. One group will receive active rTMS treatment and one will receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on an outpatient basis. All trial related medical care is provided at no cost to the participant.
Major Depressive Disorder
Device: Repetitive Transcranial Magnetic Stimulation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Parallel-Group, Sham-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of the Neuronetics Model 2100 CRS Repetitive Transcranial Magnetic Stimulation (rTMS) System in Patients With Major Depression|
- • Evaluate the antidepressant effect of a specified treatment course of rTMS compared to sham treatment given under the same experimental conditions [ Time Frame: 4 to 6 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability of rTMS [ Time Frame: screening through 30 days past last day of participation ] [ Designated as safety issue: Yes ]
- Change in depressive symptomatology with rTMS [ Time Frame: acute phase ] [ Designated as safety issue: No ]
- Short term durability of rTMS efficacy [ Time Frame: during 3 week taper ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Active Comparator: TMS
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 6 weeks
|Device: Repetitive Transcranial Magnetic Stimulation|
Placebo Comparator: Placebo
Treatment 5 days/week for up to 6 weeks
|Device: Repetitive Transcranial Magnetic Stimulation|
This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder.
Major depression is one of the most prevalent and profoundly debilitating diseases worldwide. In a recent report, it is estimated that by the year 2020, depression will be second only to heart disease in magnitude of disease burden as determined by disability-adjusted life years.
Despite major advances in the treatment of depression in the last three decades, further improvements are needed. For instance, with respect to antidepressant pharmacotherapy, only 1/3 of patients are estimated to have a nearly full resolution of their clinical symptoms with their first medication trial. Indeed, partial remission or lack of response to treatment is experienced by the majority of patients. Even with serial trials of antidepressant medication, at least 10 to 15% of patients with major depression are estimated to experience limited benefit and remain chronically depressed with significant psychosocial morbidity. Some patients cannot tolerate the dosage and duration of antidepressant treatments required for treatment trials to be considered adequate. In such patients, intolerance of somatic treatments for major depression leads to chronicity and impaired function, and likely hinders long-term compliance with treatments. For many patients with treatment resistant depression (TRD), more complex regimens of polypharmacotherapy, or the use of electroconvulsive therapy (ECT) are the only currently available treatment options.
Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative to treatments such as ECT or pharmacotherapy for patients presenting with MDD. An rTMS procedure is non-invasive, does not require anesthesia, and may be delivered in an appropriately staffed outpatient setting.
By creating a time-varying magnetic field that is unimpeded by the scalp and skull, TMS can focally and painlessly stimulate the cortex of awake individuals. Through the principle of magnetic induction, the localized pulsed magnetic field generated in the coil at the surface of the head induces an electrical current that depolarizes underlying superficial neurons. It is widely thought that rTMS produces its behavioral effects solely through the induction of current flow in cortex.
Several factors have driven the investigation of rTMS for the treatment of MDD. Early reports of changes in mood in normal participants, the non-invasive nature of rTMS, the favorable side effect profile compared to ECT, and the non-response of a number of MDD patients to pharmacotherapy and/or ECT, all have likely played a role. Since the initial studies, there has continued to be high interest in rTMS as an antidepressant treatment. Multiple trials have been conducted from researchers in diverse environments around the world. However, until now, there have been no rigorously conducted large, multicenter rTMS clinical trials in the treatment of patients with MDD. Because the published research has largely been conducted in single centers, the sample sizes in these antidepressant trials have been small. However, the majority of more than 20 reports have found modest to large antidepressant effects that increase over the trial period. By design, this trial will provide more robust information regarding the antidepressant effect of rTMS in the adult population of MDD patients.
|United States, California|
|Poway, California, United States, 92064|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Northwestern University School of Medicine|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|UVA Center for Psychiatric Clinical Research|
|Charlottesville, Virginia, United States, 22903|