NCT00807937已完成2 期
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder (GAD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
研究概览
简要总结
The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent before any study-related procedures start.
- •The patient is previously diagnosed with Generalized Anxiety Disorder.
- •The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.
排除标准
- •Patient has a lifetime history of schizophrenia or other psychotic disorders
- •Patient has a history of seizures or seizure disorder.
- •Patient is pregnant or breast feeding.
- •Patient has received electroconvulsive treatment (ECT) in the past.
研究组 & 干预措施
A
Experimental
AZD7325 5mg twice daily
干预措施: AZD7325 (Drug)
B
Experimental
AZD7325 15mg twice daily
干预措施: AZD7325 (Drug)
C
Active Comparator
Lorazepam 2mg twice daily
干预措施: Lorazepam (Drug)
D
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
时间窗: Baseline to week 4
HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization
次要结局
- Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score(Baseline to week 4)
- Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score(Baseline to week 4)
- Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score(Baseline to week 4)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score(Baseline to week 4)
研究者
研究点 (1)
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