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Deep Transcranial Magnetic Stimulation

Phase 2

Major Depressive Disorder | Unknown | Psychiatry |BrainsWay Ltd.|Last Updated: Jan 18, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Deep Transcranial Magnetic Stimulation · 1 trial · 1 indication

Phase 2 1
NCT01409304Effectiveness of Deep Transcranial Magnetic Stimulation in DepressionMajor Depressive Disorder
COMPLETED18 Analytics
PHASE2COMPLETED
Effectiveness of Deep Transcranial Magnetic Stimulation in Depression
Major Depressive DisorderUnlock trial analytics

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 to 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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Frequently asked questions about Deep Transcranial Magnetic Stimulation

What is Deep Transcranial Magnetic Stimulation used for?

Deep Transcranial Magnetic Stimulation is an investigational therapy being studied for the treatment of Major Depressive Disorder. It is a non-invasive psychiatric intervention that is currently in clinical development, with one completed Phase 2 trial evaluating its effectiveness in patients with this condition.

Who makes Deep Transcranial Magnetic Stimulation?

Deep Transcranial Magnetic Stimulation is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The company is conducting clinical research to evaluate the therapy's potential in treating Major Depressive Disorder.

What phase is Deep Transcranial Magnetic Stimulation in?

Deep Transcranial Magnetic Stimulation is in Phase 2 of clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied for safety and effectiveness in treating Major Depressive Disorder.

What clinical trials is Deep Transcranial Magnetic Stimulation in?

Deep Transcranial Magnetic Stimulation has one completed clinical trial, identified as NCT01409304, titled 'Effectiveness of Deep Transcranial Magnetic Stimulation in Depression.' This Phase 2 study enrolled 18 participants with Major Depressive Disorder and was conducted in Canada.

Is Deep Transcranial Magnetic Stimulation FDA approved?

Deep Transcranial Magnetic Stimulation is not FDA approved. It is an investigational therapy currently in Phase 2 clinical development for Major Depressive Disorder. The therapy has completed one clinical trial, but it has not yet received regulatory approval for commercial use.