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)

Brainsway9 个研究点分布在 3 个国家目标入组 104 人2024年4月29日

适应症Major Depressive Disorder

干预措施Brainsway Deep TMS System

概览

阶段: 不适用
干预措施: Brainsway Deep TMS System
疾病 / 适应症: Major Depressive Disorder
发起方: Brainsway
入组人数: 104
试验地点: 9
主要终点: Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2024年4月29日

结束日期

2026年3月5日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Brainsway

责任方

Sponsor

入排标准

入选标准

•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 ≥
•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.

排除标准

•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

研究组 & 干预措施

Investigational stimulation group

The experimental group will receive the new investigational deep TMS protocol

干预措施: Brainsway Deep TMS System

Standard-of-care stimulation group

The control group will receive the currently FDA-cleared standard-of-care deep TMS protocol.

干预措施: Brainsway Deep TMS System

结局指标

主要结局

Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group

时间窗: 6 weeks

Change in Hamilton Depression Rating Scale (HDRS)-21 scores from baseline to the 6 week follow up

次要结局

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)