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Repetitive Transcranial Magnetic Stimulation

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment286
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00104611Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive DisorderPHASE3 COMPLETED 286Jan 1, 2004Nov 1, 2005Sep 20, 201313 United States
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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 — 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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