NCT00108836已完成2 期
Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 24
- 主要终点
- Mean reduction in anxiety from baseline to week 6
研究概览
简要总结
This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.
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
- Double
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
- •Current doctor's diagnosis of generalized anxiety disorder
- •In need of psychiatric treatment
- •Willingness to complete all aspects of the study
排除标准
- •Current doctor's diagnosis of major depression
- •History of schizophrenia or schizoaffective disorders
- •Drug dependence within 2 months prior to study start
- •For detailed information on eligibility, please contact the study center nearest to you (see below), or call 1-862-778-8300, or visit the following website:
- •www.novartisclinicaltrials.com
结局指标
主要结局
Mean reduction in anxiety from baseline to week 6
次要结局
- The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
- Pharmacokinetic assessments at baseline
- Pharmacogenetic assessments at baseline
- Pharmacogenomic and proteomic assessments at baseline
- Metabonomic assessments at visits 4, 7 and 10
研究者
研究点 (24)
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