NCT01046630已完成1 期
A Phase I, Multi-centre, Double-blind, Placebo-controlled Parallel Group Study to Assess the pharmacoMRI Effects of AZD6765 in Male and Female Subjects Fulfilling the Criteria for Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Measurements of BOLD signal in the brain area BA25
研究概览
简要总结
The purpose of this study is to determine the effect of a single dose infusion of AZD 6765 compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI (functional Magnetic Resonance Imaging) in depressed subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented clinical diagnosis meeting criteria from the DSM-IV by structured clinical interview,major depressive disorder, single episode or recurrent
- •Outpatient status at screening and at randomisation
排除标准
- •A major depression disorder which has a major impact on the subjects current psychiatric status
- •Subjects not allowed to use mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs
- •Subjects with lifetime history of schizophrenia, bi-polar, psychosis and psychotic depression
研究组 & 干预措施
1
Experimental
single infusion
干预措施: AZD6765 (Drug)
2
Active Comparator
single infusion
干预措施: Ketamine (Drug)
3
Placebo Comparator
single infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Measurements of BOLD signal in the brain area BA25
时间窗: Day1 (at infusion)
次要结局
- Measurements of symptoms of depression using Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory total score(once during Day -30 to Day -1, twice Day 1 (pre and 4hrs post infusion) [BDI only pre-infusion], once Day 2 (approx 24hrs post infusion), once Day 9-12)
- Responses on a computer based battery of behavioral tasks(Day2 (approx 24 post infusion))
- Pharmacokinetics of AZD6765(Max 3 times Day1 (pre-infusion, end of infusion, 4 hrs end of infusion), Max once Day2 (approx 24 hrs post infusion))
研究者
研究点 (1)
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