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Repetitive Transcranial Magnetic Stimulation

Phase 3

Major Depressive Disorder | Unknown | Psychiatry |Neuronetics, Inc.|Last Updated: Sep 20, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment286

FDA Designations

No designations recorded

Clinical trial landscape

Repetitive Transcranial Magnetic Stimulation · 1 trial · 1 indication

Phase 3 1
NCT00104611Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive DisorderMajor Depressive Disorder
COMPLETED286 Analytics
PHASE3COMPLETED
Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

• Evaluate the antidepressant effect of a specified treatment course of rTMS compared to sham treatment given under the same experimental conditions
4 to 6 weeks

Secondary Endpoints

Safety and tolerability of rTMS
screening through 30 days past last day of participation
Change in depressive symptomatology with rTMS
acute phase
Short term durability of rTMS efficacy
during 3 week taper
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TMSACTIVE_COMPARATORRepetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 6 weeks
PlaceboPLACEBO_COMPARATORTreatment 5 days/week for up to 6 weeks

Interventions

NameTypeDescription
Repetitive Transcranial Magnetic StimulationDEVICE -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single or recurrent episode as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional stipulation of a duration for this episode of greater than or equal to 4 weeks and CGI...

Countries:United States
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Frequently asked questions about Repetitive Transcranial Magnetic Stimulation

What is Repetitive Transcranial Magnetic Stimulation used for?

Repetitive Transcranial Magnetic Stimulation (rTMS) is used for the treatment of Major Depressive Disorder. It is an investigational therapy being studied in a Phase 3 clinical trial. The treatment is delivered using a device developed by Neuronetics, Inc. for patients with this psychiatric condition.

Who makes Repetitive Transcranial Magnetic Stimulation?

Repetitive Transcranial Magnetic Stimulation is developed by Neuronetics, Inc., a company traded on the stock exchange under the ticker symbol STIM. The company is conducting clinical research to evaluate this treatment for Major Depressive Disorder.

What phase is Repetitive Transcranial Magnetic Stimulation in?

Repetitive Transcranial Magnetic Stimulation is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the treatment is being studied for Major Depressive Disorder.

What clinical trials is Repetitive Transcranial Magnetic Stimulation in?

Repetitive Transcranial Magnetic Stimulation has one completed Phase 3 clinical trial registered under NCT00104611. This study, titled 'Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder,' enrolled 286 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.

Is Repetitive Transcranial Magnetic Stimulation FDA approved?

Repetitive Transcranial Magnetic Stimulation is not FDA approved. It is an investigational therapy currently in Phase 3 clinical development for Major Depressive Disorder. The Phase 3 trial has been completed, but approval status has not been established.