Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104611
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2005-03-02
Brief Title:
Study of a Repetitive Transcranial Magnetic Stimulation rTMS Device for the Treatment of Major Depressive Disorder
Sponsor:
Neuronetics
Organization:
Neuronetics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 13 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 andor 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
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 13 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None