A Prospective Multicenter Double Blind Randomized Controlled Trial to Demonstrate That the Efficacy of the H7-Coil is as Good as the Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (DTMS) in Subjects With Major Depression Disorder (MDD)
试验速览
- 阶段
- 不适用
- 发起方
- Brainsway
- 入组人数
- 106
- 试验地点
- 18
- 主要终点
- HDRS-21 Score Change From Baseline
研究概览
简要总结
The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medications.
详细描述
This is a prospective, 6 week, double blind, randomized, controlled, multi-center trial. The study will explore the safety and efficacy of deep brain rTMS (Transcranial Magnetic Stimulation) H7-Coil treatment and demonstrate that it is as good as the FDA cleared, H1-Coil treatment as add-on for a treatment with antidepressant drugs (a bi-therapeutic treatment ) in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medication.
Approximately 146 subjects will be enrolled in the study. The study population consists of subjects with MDD who have failed adequate medication treatment and who are in a current depressive episode.
The patients will be of all racial, ethnic and gender categories, ranging from 22 to 68 years of age, and have HDRS-21≥20. Outpatients will be recruited from both academic and private research centers.
The study duration is 8 weeks, with a 2 week period of screening and baseline, followed by 4 weeks of 5 daily treatments and 2 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and assessments during the screening and baseline and throughout treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Men and women 22-68 years of age
- •Primary DSM-IV diagnosis of Major Depression, single or recurrent episode.
- •Current depressive episode is less than 5 years duration
- •The patient did not respond to at least one but not more than four antidepressant treatments in the current episode or Patients who have not completed antidepressant trials due to intolerance to therapy of 2 or more anti-depressant medications in the current episode
- •Satisfactory safety screening questionnaire for transcranial magnetic stimulation
- •Patients not suffering from hypo or hyper-thyroidism based on pre-study TSH level or medically stabilized
- •Capable and willing to provide informed consent and able to adhere to the treatment schedule
- •Patient is stable on medication for 2 month and is not expected to change medication during all study period
排除标准
- •Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- •Depression secondary to a general medical condition, or substance-induced
- •History of substance abuse or dependence within the past 6 month (except nicotine and caffeine)
- •Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features, Bipolar disorder, Eating disorder, Obsessive compulsive disorder
- •Post-traumatic stress disorder (current or within the past year)
- •Current generalized anxiety disorder, panic disorder or social anxiety disorder
- •Presence of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic)
- •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 ECT
- •History of cerebrovascular accident
- •Transient ischemic attack within two years
- •Cerebral aneurysm
- •Mini Mental State Exam score of less than or equal to 24
- •Parkinson's disease
- •Huntington's chorea
- •Multiple sclerosis
- •Increased risk of seizure for any reason
- •Individuals with hearing loss
- •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 randomization visit
- •Use of any prohibited study medication(s)
- •Present suicidal risk as assessed by the investigator or significant suicide risk
- •Any self-inflicted harm in the past 3 months not in the context of suicidal ideation
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
- •Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- •Implanted neurostimulators
- •History of abnormal MRI
- •Known or suspected pregnancy
- •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 laboratory abnormality, in the opinion of the Investigator based on CBC and biochemistry
- •Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
- •Women: if pregnant, planning on becoming pregnant, or currently nursing
结局指标
主要结局
HDRS-21 Score Change From Baseline
时间窗: Week 6 post randomization
Change from baseline in HDRS-21 scores at week 6 post-randomization in the H7 group compared to the H1 group
次要结局
- Response Rate in HDRS-21(Week 6 post randomization)
- Remission Rate(Week 6 post randomization)