Major Depressive Disorder Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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