New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD)

NCT06357832 | Completed FDA Device

• 1 other identifier: CTP-ACCiTBS-00
• Study Type: interventional
• Target: 104
• Locations: 3 countries
• Sites: 9

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (4)

• Response rate in the investigational group

  6 weeks

• Remission rate in the investigational group

  6 weeks

• Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group

  6 week

• Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group

  6 week

Study Arms (2)

Investigational stimulation group

EXPERIMENTAL

The experimental group will receive the new investigational deep TMS protocol

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.

Device: Brainsway Deep TMS System

Interventions

Brainsway Deep TMS System 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.

Also known as: Brainsway Deep TMS Device

Investigational stimulation group; Standard-of-care stimulation group

Eligibility Criteria

• Age: 22 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Brainsway: lead

Study Sites (9)

Novus Neurology

Tuscaloosa, Alabama, 35401, United States

Location

Inland Psychiatric Medical Group, Inc.

Redlands, California, 92373, United States

Location

DTMS Center LLC

Palm Beach, Florida, 33401, United States

Location

Fermata Health

Brooklyn, New York, 11249, United States

Location

Complete Mind Care of PA

Abington, Pennsylvania, 19001, United States

Location

ClearPath Psychiatry

Seattle, Washington, 98105, United States

Location

PsyCare

South Charleston, West Virginia, 25303, United States

Location

Asha Neuromodulation Clinic

Hyderabad, Telangana, 500032, India

Location

Be'er Ya'aqov-Ness Ziona Mental Health Center

Be’er Ya‘aqov, 70350, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: April 29, 2024
• Primary Completion: February 26, 2025
• Study Completion: March 5, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (7); IL (1); IN (1)