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Deep Transcranial Magnetic Stimulation

Phase 2

Major Depressive Disorder | Unknown | Psychiatry |BrainsWay Ltd.|Last Updated: Jan 18, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01409304Effectiveness of Deep Transcranial Magnetic Stimulation in DepressionPHASE2 COMPLETED 18Oct 1, 2011Dec 1, 2012Jan 18, 20131 Canada
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Study Endpoints
Primary Endpoints
21-item Hamilton Depression Rating Scale (HAM-D21)
week 5

Response to treatment is defined as a ≥ 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score ≤ 9.

Secondary Endpoints
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
week 5
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Deep Transcranial Magnetic Stimulation (DTMS)DEVICEDTMS will be administered according to the following parameters: 18 Hz in 84 trains of 2 seconds duration, with 20 seconds inter-train interval (3,024 pulses per session) at 120% of the resting motor threshold.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 1 but ≤ 5 adequate antidepressant trial(s) in the current episode * Baseline score ≥ 15 on the QIDS-C * Stable medication regimen (\> 4 weeks) Exclusion Criteria: * Psy...

Countries:Canada
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