NCT00616447已完成不适用
A 12-week, Double-blind, Randomized, Placebo-controlled Multicentered Study Evaluating Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Generalized Anxiety Disorder (GAD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Hamilton Anxiety Rating Scale (ham-a)
研究概览
简要总结
This study will compare the change detected by a standardized rating scale (Hamilton Anxiety Rating Scale) scores in the active treatment group as compared to sham (placebo) group after 6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to improvement of core symptoms in patients with GAD.
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 GAD diagnosis;
- •HARS >=15;
- •male/female 18-65 years;
- •without GAD pharmacotherapy at least last 2 weeks or if they are taking GAD medication it must be stable for at least 6 weeks prior to the start of the study and not be changed during the 6 weeks of the study treatment phase.
- •Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.
排除标准
- •current serious Axis I schizophrenia, bipolar I, MDD;
- •other primary Axis I in the opinion of investigator;
- •HDRS >=18;
- •metallic implant in cranium except mouth;
- •severe/unstable medical conditions;
- •ect within last 3 months;
- •history epilepsy;
- •neurological disorder leading to increased intracranial pressure;
- •severe cardiac disorder/intracardiac lines/pacemakers;
- •current suicide risk.
结局指标
主要结局
Hamilton Anxiety Rating Scale (ham-a)
时间窗: baseline, week 2, 4, 6, 8, 12
次要结局
- Hamilton Depression Rating Scale-21(baseline, week 2, 4, 6, 8, 12)
- Clinical Global Impression(baseline, 2, 4, 6, 8, 12)
- Pittsburgh Sleep Quality Index(baseline, week 2, 4, 6, 8, 12)
- SF-36 QOL version (1)(baseline, week 2, 4, 6, 8, 12)
- Visual Analogue Scales(baseline, week 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 (3)
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