ChiCTR-IOR-14005602进行中（未招募）不适用
定位低頻連環顱外磁激治療對抗藥性鬱躁性抑鬱症隨機對照試驗
Food and Health Bureau1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinically significant response defined as 50% reduction in MADRS from baseline and CGI equal or less than 2 at end of treatment at week 3
研究概览
简要总结
定位低頻連環顱外磁激治療對抗藥性鬱躁性抑鬱症
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •Right-handed - Aged 18-65 - DSM5 Bipolar I or II Disorder - Currently in DSM5 Major Depressive episode lasting for 6 weeks or more - No DSM5 manic or hypomanic episode in the past week - MADRS score >20 - Clinical Global Impression severity of illness scale of or more than 4 - All patients must be on lithium ( plasma levels 0.5 to 1.0 mmol/L) or sodium valproate (plasma levels >350mmol/L) or lamotrigine. -Showed no response (defined as lack of significant reduction of MADRS total score 25% or less compared to pre-treatment scores) to at least one adequate antidepressant trial (defined as full or best tolerated doses for at least 6 weeks; antidepressants may include bupropion or SSRI apart from paroxetine. -Currently making valid informed written consent
排除标准
- •Organic brain syndromes -Current psychotic symptoms -Mental retardation -substance use in recent 3 months -active suicidal ideation or suicide attempt in the past month -obsessive-compulsive disorder, PTSD, eating disorders -Lack of response to adequate trial of electroconvulsive therapy -Previous rTMS treatment -Current pregnancy -Personal or known 1st-degree relatives’ history of seizures -Presence of metallic implants or aneurysm clips -Unstable cardiac disease
研究组 & 干预措施
Two groups
Repetitive Transcranial Magnetic Stimulation for three weeks versus An inactive Sham coil
结局指标
主要结局
Clinically significant response defined as 50% reduction in MADRS from baseline and CGI equal or less than 2 at end of treatment at week 3
次要结局
- Rate of treatment-emergent DSM5
- manic or hypomanic episodes from low-frequency stimulation of right DLPFC in BPI or II Depression by week 4.
- Early remission rate defined as MADRS <7 and CGI=1 at week 3
- Sustained response and remission rate at weeks 6 and 12 after treatment initiation.
研究者
研究点 (1)
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