Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06357832
Other study ID # CTP-ACCiTBS-00
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 29, 2024
Est. completion date February 28, 2025

Study information

Verified date June 2024
Source Brainsway
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 104
Est. completion date February 28, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 68 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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.

Study Design


Intervention

Device:
Brainsway Deep TMS System
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.

Locations

Country Name City State
United States Complete Mind Care of PA Abington Pennsylvania
United States Fermata Health Brooklyn New York
United States DTMS Center LLC Palm Beach Florida
United States ClearPath Psychiatry Seattle Washington
United States PsyCare South Charleston West Virginia
United States Novus Neurology Tuscaloosa Alabama

Sponsors (1)

Lead Sponsor Collaborator
Brainsway

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 6 weeks
Secondary Remission rate in the investigational group The percentage of patients in the investigational group with an HDRS-21 score < 10 at 6 weeks 6 weeks
Secondary 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 6 week
Secondary 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 6 week
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A