A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- MADRS Total Score Change From Baseline to Week 6
研究概览
简要总结
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
详细描述
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.
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
- •Provision of signed, written, and dated Informed Consent
- •Documented primary clinical diagnosis of Major Depressive Disorder
排除标准
- •Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder
- •Patients whose current episode of depression started less than 4 weeks before enrollment
- •History of inadequate response of antidepressants during current depressive episode
研究组 & 干预措施
AZD2066
干预措施: AZD2066 (Drug)
Placebo
干预措施: Placebo (Drug)
Duloxetine
Duloxetine
干预措施: Duloxetine (Drug)
结局指标
主要结局
MADRS Total Score Change From Baseline to Week 6
时间窗: 6 weeks
Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.
次要结局
- MADRS Response(6 weeks)
- MADRS Remission(6 weeks)