NCT00672373已完成3 期
A Double-Blind, Randomised, Parallel-Group Comparison of Extract of Ginkgo Biloba(EGB-761) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
研究概览
简要总结
The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia
详细描述
Tardive dyskinesia(TD) is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. There is no established treatment for TD patients.This disorder remains a significant clinical problem for both patients and physicians for the foreseeable future.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 60yrs
- •Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition(DSM-IV) criteria for schizophrenia or schizo-affective disorder
- •Abnormal Involuntary Movement Scale (AIMS) score ≥
- •Patients from whom informed, written consent is obtained.
- •Patients who have been on a fixed dose of antipsychotic medication for at least 4 weeks prior to trial entry.
排除标准
- •Significant neurological disorder other than TD
- •Substance abuse
- •Significant other medical illness
- •Psychiatric disorder not stabilised
- •Pregnancy or lactation
- •Take antioxidants(such as Vitamin C)
研究组 & 干预措施
A
Experimental
Active treatment with EGb-761 capsules (80mg each capsule), 3 capsules each day for 12 weeks
干预措施: Extract of Ginkgo Biloba (EGb-761 capsules) (Drug)
B
Placebo Comparator
Matching placebo treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
时间窗: Baseline, 6th and 12th week
次要结局
- Change in PANSS(Baseline, 6th and 12th week)
- Change in Simpson-Angus Rating Scales for EPS(Baseline, 6th and 12th)
- Change in cognitive function(Baseline and 12th week)
- Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale(Baseline, 6th and 12th week)
研究者
研究点 (1)
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