JPRN-jRCTs042220011进行中（未招募）1 期
Safety and efficacy of the extremely low frequency-weak magnetic fields (ELF therapy) in the treatment of depressive disorders: a preliminary exploratory open trial - ELF
Inada Toshiya0 个研究点目标入组 4 人开始时间: 2022年4月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. 18 to 75 years old, male and female
- •2. Patients who met the diagnostic criteria for a depressive episode according to DSM-5
- •3. Patients with a total MADRAS score of 22 or higher at baseline.
- •4. Patients whose written consent to participate in this study has been obtained from them.
排除标准
- •1.Patients who met the following disorders according to the DSM-5 (delirium, dementia,amnesia and other cognitive disorders; schizophrenia and other psychotic disorders; mental retardation, etc.)
- •2.Patients who met the diagnostic criteria for substance abuse and substance dependence according to the DSM-5 within 24 weeks (excluding nicotine-related or caffeine-related disorders)
- •3.Patients with intracranial lesions with a history of or at risk for epilepsy/convulsive seizures. Patients who take drugs that risk lowering the convulsive threshold; tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, etc.
- •4.Patients with a score of 4 or higher on item 10 (suicidal thoughts) of the MADRAS who are at high risk of suicide, or patients who are judged by the principal investigator to be at high risk of suicide.
- •5.Patients who have had a change in pharmacotherapy within 4 weeks
- •6.Patients who received other investigational drugs or standard psychotherapy such as cognitive behavioral therapy, interpersonal therapy, or psychoanalytic therapy within 16 weeks
- •7.Patients who received electroconvulsive therapy or high intensity light therapy within 16 weeks
- •8.Patients with serious complications such as diseases of the liver, kidney, blood, respiratory organs, digestive organs, cardiovascular system, metabolic and electrolyte abnormalities, or hypersensitivity
- •9.Patients with metals in close proximity to the stimulation site (cochlear implants, magnetic clips, stimulators such as deep brain stimulation or vagus nerve stimulation, intracranial titanium products, magnetized dentures or implants), cardiac pacemakers
- •10.pregnant patients
- •11.Patients who, for any other reason, are judged by the investigator to be inappropriate for participation in the study.
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