Major Depressive DisorderPhase 4NCT04679753
Brainsway DTMS for Treatment of MDD Using iTBS
A Phase 4 study testing Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) and Brainsway DTMS with High Frequency (HF) Stimulation in people with Major Depressive Disorder, run by Brainsway at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) and Brainsway DTMS with High Frequency (HF) Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 1 Jul 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- Diagnosis of Major Depression Disorder
Who cannot join
- Other significant Axis I psychiatric disorder with greater impairment than MDD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brainsway Deep TMS System for Treatment of Major Depressive Disorder (MDD) Using Intermittent Theta Burst Stimulation (iTBS) Protocol
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.
Read the detailed description
The purpose of the study is to evaluate the safety and efficacy of Brainsway Deep TMS for the treatment of Major Depressive Disorder using the iTBS stimulation protocol, by comparing it to clinical data collected in the Brainsway randomized, controlled Multicenter study (CTP-001-00), using the HF DTMS stimulation protocol used in support of the Brainsway DTMS device 510(k) K122288.
In the post-marketing study, patients will be treated with an intermittent theta burst (iTBS) protocol, using the same Brainsway DTMS device with the same H1-Coil. Furthermore, the treatment paradigm is the same, consisting of TMS sessions performed daily for 5 weeks (20 DTMS sessions). The iTBS stimulation protocol consists of bursts of 3 pulses at 50 Hz, 5 Hz bursts frequency, 2s on and 8s off, 600 pulses per session. The HF stimulation protocol was delivered at 18 Hz, 120% stimulation intensity of the resting MT, 55 trains of 2s duration, inter-train interval (ITI) of 20s, for 1980 pulses per session.
The clinical study design includes multiple measurements of safety and effectiveness parameters.
The primary outcome measure is the change from baseline in HDRS-21 scores at the 5 week visit (after 20 treatment sessions). The success criteria of the study is a non-inferiority margin of 3.0 points.
The secondary efficacy endpoints of the study include evaluation of the response and remission rates, based on HDRS-21 scores, at the 5 week visit, change in CGI-S score from baseline to 6 weeks and response and remission rates based on CGI-S scores at the 6 week visit.
Safety will be assessed at each treatment visit. Patients will be asked to report any adverse event since their previous visit.
- Conditions
- Major Depressive Disorder
- Being tested
- Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS), Brainsway DTMS with High Frequency (HF) Stimulation
- Keywords
- intermittent Theta Burst Stimulation, iTBS, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)Device
Brainsway DTMS with iTBS
Brainsway DTMS with High Frequency (HF) StimulationDevice
Brainsway DTMS with HF
| Study group | Role | What they receive |
|---|---|---|
| Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) | Active comparator | Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) Receives: 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) Receives: Device: Brainsway DTMS with High Frequency (HF) Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (3)
HDRS-21 Response and Remission rates
Evaluation of the response and remission rates based on HDRS-21 scores
Measured: 5 weeks
Change in CGI-S score from baseline at the 6 week visit
Clinical Global Improvement - Severity Scale (CGI-S), where minimum score is 1 and maximum score is 7, and where higher scores mean a worse outcome.
Measured: 6 weeks
CGI-S Response and Remission rates
Evaluation of the response and remission rates based on CGI-S scores
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jan 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Brainsway Deep TMS with intermittent Theta Burst Stimulation (iTBS)
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oluremi Adefolarin, MD, Principal investigator, SynapseTMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679753
- Sponsor's protocol ID
- CTP-0001-03
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brainsway Deep TMS System for Treatment of Major Depressive Disorder (MDD) Using Intermittent Theta Burst Stimulation (iTBS) Protocol
- ClinicalTrials.gov ID
- NCT04679753
- Acronym / sponsor ID
- CTP-0001-03
- Conditions
- Major Depressive Disorder
- Keywords
- intermittent Theta Burst Stimulation, iTBS, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to evaluate the safety and efficacy of Brainsway Deep TMS for the treatment of Major Depressive Disorder using the iTBS stimulation protocol, by comparing it to clinical data collected in the Brainsway randomized, controlled Multicenter study (CTP-001-00), using the HF DTMS stimulation protocol used in support of the Brainsway DTMS device 510(k) K122288.
In the post-marketing study, patients will be treated with an intermittent theta burst (iTBS) protocol, using the same Brainsway DTMS device with the same H1-Coil. Furthermore, the treatment paradigm is the same, consisting of TMS sessions performed daily for 5 weeks (20 DTMS sessions). The iTBS stimulation protocol consists of bursts of 3 pulses at 50 Hz, 5 Hz bursts frequency, 2s on and 8s off, 600 pulses per session. The HF stimulation protocol was delivered at 18 Hz, 120% stimulation intensity of the resting MT, 55 trains of 2s duration, inter-train interval (ITI) of 20s, for 1980 pulses per session.
The clinical study design includes multiple measurements of safety and effectiveness parameters.
The primary outcome measure is the change from baseline in HDRS-21 scores at the 5 week visit (after 20 treatment sessions). The success criteria of the study is a non-inferiority margin of 3.0 points.
The secondary efficacy endpoints of the study include evaluation of the response and remission rates, based on HDRS-21 scores, at the 5 week visit, change in CGI-S score from baseline to 6 weeks and response and remission rates based on CGI-S scores at the 6 week visit.
Safety will be assessed at each treatment visit. Patients will be asked to report any adverse event since their previous visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Brainsway Deep TMS with intermittent Theta Burst Stimulation (iTBS)
| Arm | Type | Receives |
|---|---|---|
| Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) | Active comparator | Device: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) |
| Brainsway DTMS with High Frequency Stimulation (HF) | Active comparator | Device: Brainsway DTMS with High Frequency (HF) StimulationBrainsway DTMS with High Frequency Stimulation (HF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients
- Diagnosis of Major Depression Disorder
Key exclusion criteria (1 listed)
- Other significant Axis I psychiatric disorder with greater impairment than MDD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)Brainsway DTMS with iTBS | Device | Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) |
| Brainsway DTMS with High Frequency (HF) StimulationBrainsway DTMS with HF | Device | Brainsway DTMS with High Frequency Stimulation (HF) |
Primary outcome
The primary outcome measure was the change from baseline in HDRS-21 scores at the 5 week visit.
Time frame: 5 weeks
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.
3 secondary outcomes
HDRS-21 Response and Remission rates
Time frame: 5 weeks
Change in CGI-S score from baseline at the 6 week visit
Time frame: 6 weeks
CGI-S Response and Remission rates
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oluremi Adefolarin, MD principal investigator
SynapseTMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) and Brainsway DTMS with High Frequency (HF) Stimulation in people with Major Depressive Disorder, run by Brainsway at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure was the change from baseline in HDRS-21 scores at the 5 week visit. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.