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

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT06357832

Run by

Brainsway

People needed

104

Starts

2024-04-29

Expected to finish

2026-03-05

Last updated by the study team

2026-03-10

Who can join

Age: 22 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Novus Neurology — Tuscaloosa, Alabama, United States
• Inland Psychiatric Medical Group, Inc. — Redlands, California, United States
• DTMS Center LLC — Palm Beach, Florida, United States
• Fermata Health — Brooklyn, New York, United States
• Complete Mind Care of PA — Abington, Pennsylvania, United States
• ClearPath Psychiatry — Seattle, Washington, United States
• PsyCare — South Charleston, West Virginia, United States
• Asha Neuromodulation Clinic — Hyderabad, Telangana, India
• Be'er Ya'aqov-Ness Ziona Mental Health Center — Be’er Ya‘aqov, Israel

Full record on ClinicalTrials.gov

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