NCT00616486已完成不适用
A Multicentre, Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy, Safety, and Clinical Outcomes of Low Frequency, Repetitive Transcranial Magnetic Stimulation (Over Supplementary Motor Area (SMA) Applied Bilaterally and Simultaneously) Versus Sham (Placebo rTMS) Treatment for 6 Weeks, When Added to a Stable Pharmacotherapy in Subjects With Obsessive Compulsive Disorder (OCD).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
Low frequency (1Hz) rTMS applied bilaterally and simultaneously over SMA for 6 weeks in addition to the standard treatment regimen for OCD, will lead to significant improvement in patients' symptoms. The clinical improvement detected by YBOCS, CGI and SF-36 QOLS scores will be statistically significant in active treatment group compared to sham (placebo) treatment group.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed patient informed consent;
- •primary obsessive compulsive disorder;
- •YBOCS score at least 20;
- •males/females 18-65yrs;
- •treated with adequate dose of SSRI at least 8 weeks at some stage of illness;
- •currently using adequate, stable dose of SSRI at least 4 weeks but not responding.
排除标准
- •schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (HDRS(17)>18, substance/alcohol dependence within last 6 months;
- •severe axis II;
- •suicidal score>=6 on MINI;
- •metallic implant in cranium;
- •severe/unstable medical conditions;
- •not responding to ECT or had TMS in last 6 months;
- •history epilepsy;
- •neurological disorder leading to increased intracranial pressure;
- •severe cardiac disorder/intracardiac lines, pacemakers;
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: pre, week 1, 2, 4, 6, 8, 12
次要结局
- Clinical Global Impression(pre, week 1, 2, 4, 6, 8, 12)
- Hamilton Depression Rating Scale-21(HDRS)(pre, week 1, 2, 4, 6, 8, 12)
- Hamilton Anxiety Rating Scale (HARS)(pre, week 1, 2, 4, 6, 8, 12)
- Visual Analogue Scale(pre, week 1, 2, 4, 6, 8, 12)
- Pittsburgh Sleep Quality Index (PSQI)(pre, week 1, 2, 4, 6, 8, 12)
- SF-36 QOLS version (1)(pre, week 1, 2, 4, 6, 8, 12)
研究者
Dr. Roumen Milev
Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University
Queen's University
研究点 (4)
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