Brainsway DTMS for Treatment of MDD Using iTBS

NCT04679753 | Completed Phase 4

• 1 other identifier: CTP-0001-03
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

The safety and effectiveness of the BrainsWay deep transcranial magnetic stimulation (DTMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol will be evaluated in a non-inferiority study, comparing the iTBS treatment with the FDA cleared, (510(k) No. K122288) Brainsway DTMS device to the High Frequency (HF) protocol using the same device.

Conditions

Major Depressive Disorder

Keywords

intermittent Theta Burst Stimulation; iTBS; Depression

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure was the change from baseline in HDRS-21 scores at the 5 week visit.

  Hamilton Depression Rating Scale (HDRS-21 items), where minimum score is 0 and maximum score is 53, and where higher scores mean a worse outcome. The success criteria of the study was a non-inferiority margin of 3.0 points.

  5 weeks

Secondary Outcomes (3)

• HDRS-21 Response and Remission rates

  5 weeks

• Change in CGI-S score from baseline at the 6 week visit

  6 weeks

• CGI-S Response and Remission rates

  6 weeks

Study Arms (2)

Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

ACTIVE COMPARATOR

Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Device: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Brainsway DTMS with High Frequency Stimulation (HF)

ACTIVE COMPARATOR

Brainsway DTMS with High Frequency Stimulation (HF)

Device: Brainsway DTMS with High Frequency (HF) Stimulation

Interventions

Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) DEVICE

Brainsway DTMS with iTBS

Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Brainsway DTMS with High Frequency (HF) Stimulation DEVICE

Brainsway DTMS with HF

Brainsway DTMS with High Frequency Stimulation (HF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients
• Diagnosis of Major Depression Disorder

You may not qualify if:

• Other significant Axis I psychiatric disorder with greater impairment than MDD

Sponsors & Collaborators

• Brainsway: lead

Study Sites (1)

SynapseTMS

Yorkton, Saskatchewan, S3N 4C6, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Oluremi Adefolarin, MD

  SynapseTMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Brainsway Deep TMS with intermittent Theta Burst Stimulation (iTBS)

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)