Major Depressive DisorderNCT06357832
New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD)
A study testing Brainsway Deep TMS System in people with Major Depressive Disorder, run by Brainsway at 9 sites in 3 countries.
Trial summary
The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Brainsway Deep TMS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 29 Apr 2024to 5 Mar 2026
- Phase
- Interventional
- 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 22 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients.
- Men and women 22-68 years of age.
- Primary Diagnostic and Statistical Manual (DSM-V) diagnosis of Major Depression, single or recurrent episode confirmed by the Quick Structured Clinical Interview for the DSM-5 Disorders (QuickSCID-5), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
- Current depressive episode is less than 5 years in duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-V definition of major depressive episode);
- Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit;
- The patient did not respond to at least one antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials, of adequate dose and duration (defined as a minimum level of 3 on the Antidepressant Treatment History Form - Short Form (ATHF-SF)) in the current episode; or Patients who have not completed antidepressant trials of adequate dose and duration (defined as a level of 1-2 on the ATHF-SF) due to intolerance to therapy, if they have demonstrated intolerance to 2 or more antidepressant medications in the current episode.
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- Capable and willing to provide informed consent
- Able to adhere to the treatment schedule.
- Patient is stable on medication for 2 month and is not expected to change medication during the study period.
- Satisfactory safety screening questionnaire for transcranial magnetic stimulation.
Who cannot join
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption);
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- Depression secondary to a general medical condition, or substance-induced;
- Substance abuse disorder within the past 3 months (except nicotine and caffeine). Note that use of cannabis for medical reasons in a stable regimen is permitted as long as the investigator excludes abuse of the substance.
- Any psychotic disorder (lifetime), including schizoaffective disorder or major depression with psychotic features or Bipolar disorder.
- Post-traumatic stress disorder (current or within the past year)
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- Current (within 12 months of baseline) generalized anxiety disorder, panic disorder or social anxiety disorder as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- Presence (within 12 months of baseline) of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- Individuals with a significant neurological disorder or insult including (but not limited to):
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- Any history of seizure EXCEPT those therapeutically induced by Electroconvulsive T Therapy (ECT) or febrile seizures
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Individuals with a first-degree relative family history of seizure.
- ECT treatment within 3 months prior to the screening visit
- History of treatment with Vagus Nerve Stimulation (VNS)
- History of treatment with Deep Brain Stimulation (DBS)
- Use of any investigational drug within 4 weeks of the baseline visit
- Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4, or significant suicide risk as assessed using the Scale for Suicide Ideation (SSI), or a history of attempted suicide in the last year.
- Any self-inflicted harm in the past 3 months not in the context of suicidal ideation.
- Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head (excluding the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, shrapnel, surgical clips, fragments from welding or metal work).
- Individuals who have cardiac pacemakers or active implantable electrodes/neurostimulators within 30 cm of the treatment coil.
- If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial
- Clinically significant medical condition in the opinion of the Investigator.
- Known or suspected pregnancy
- Women who are breast-feeding
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
Complete Mind Care of PA
Abington, Pennsylvania, 19001
Fermata Health
Brooklyn, New York, 11249
DTMS Center LLC
Palm Beach, Florida, 33401
Inland Psychiatric Medical Group, Inc.
Redlands, California, 92373
ClearPath Psychiatry
Seattle, Washington, 98105
PsyCare
South Charleston, West Virginia, 25303
Novus Neurology
Tuscaloosa, Alabama, 35401
Israel1 site
Be'er Ya'aqov-Ness Ziona Mental Health Center
Be’er Ya‘aqov, 70350
About this study
Official title: A Prospective, Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS) With a New Stimulation Protocol in Subjects With Major Depression Disorder (MDD)
The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study.
- Conditions
- Major Depressive Disorder
- Being tested
- Brainsway Deep TMS System
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainsway Deep TMS SystemDevice
Also called Brainsway Deep TMS Device
The BrainsWay Deep TMS device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency.
| Study group | Role | What they receive |
|---|---|---|
| Investigational stimulation group | Experimental | The experimental group will receive the new investigational deep TMS protocol Receives: Device: Brainsway Deep TMS System |
| Standard-of-care stimulation group | Active comparator | The control group will receive the currently FDA-cleared standard-of-care deep TMS protocol. Receives: Device: Brainsway Deep TMS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group
Change in Hamilton Depression Rating Scale (HDRS)-21 scores from baseline to the 6 week follow up
Measured: 6 weeks
Secondary outcomes (4)
Response rate in the investigational group
The percentage of patients in the treatment group who had a reduction of ≥50% in HDRS-21 score from baseline to the 6 week follow up
Measured: 6 weeks
Remission rate in the investigational group
The percentage of patients in the investigational group with an HDRS-21 score < 10 at 6 weeks
Measured: 6 weeks
Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group
Change in Clinical Global Impression-Severity (CGI-S) scores from baseline to the 6 week follow up
Measured: 6 week
Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group
Change in Clinical Global Impression Improvement (CGI-I) scores from baseline to the 6 week follow up
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start29 Apr 2024
- Primary completion26 Feb 2025
- Study completion5 Mar 2026
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357832
- Sponsor's protocol ID
- CTP-ACCiTBS-00
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS) With a New Stimulation Protocol in Subjects With Major Depression Disorder (MDD)
- ClinicalTrials.gov ID
- NCT06357832
- Acronym / sponsor ID
- CTP-ACCiTBS-00
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 10 Apr 2024 (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 BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational stimulation group | Experimental | Device: Brainsway Deep TMS SystemThe experimental group will receive the new investigational deep TMS protocol |
| Standard-of-care stimulation group | Active comparator | Device: Brainsway Deep TMS SystemThe control group will receive the currently FDA-cleared standard-of-care deep TMS protocol. |
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Outpatients.
- Men and women 22-68 years of age.
- Primary Diagnostic and Statistical Manual (DSM-V) diagnosis of Major Depression, single or recurrent episode confirmed by the Quick Structured Clinical Interview for the DSM-5 Disorders (QuickSCID-5), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
- Current depressive episode is less than 5 years in duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-V definition of major depressive episode);
- Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit;
Key exclusion criteria (34 listed)
- Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption);
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- Depression secondary to a general medical condition, or substance-induced;
- Substance abuse disorder within the past 3 months (except nicotine and caffeine). Note that use of cannabis for medical reasons in a stable regimen is permitted as long as the investigator excludes abuse of the substance.
- Any psychotic disorder (lifetime), including schizoaffective disorder or major depression with psychotic features or Bipolar disorder.
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 Deep TMS SystemAlso: Brainsway Deep TMS DeviceThe BrainsWay Deep TMS device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. | Device | Investigational stimulation group, Standard-of-care stimulation group |
Primary outcome
Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group
Time frame: 6 weeks
Change in Hamilton Depression Rating Scale (HDRS)-21 scores from baseline to the 6 week follow up
4 secondary outcomes
Response rate in the investigational group
Time frame: 6 weeks
Remission rate in the investigational group
Time frame: 6 weeks
Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group
Time frame: 6 week
Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group
Time frame: 6 week
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 10 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brainsway Deep TMS System in people with Major Depressive Disorder, run by Brainsway at 9 sites in 3 countries.
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 10 inclusion and 34 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, India, Israel. 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.
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?
Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group (time frame: 6 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 10 Mar 2026.