NCT00781742已完成2 期
A Phase IIb, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Efficacy and Safety Study of Adjunctive AZD6765 in Subjects With Severe Major Depressive Disorder (MDD) and a History of Poor Response to Antidepressants
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
- 152
- 试验地点
- 1
- 主要终点
- To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score
研究概览
简要总结
The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).
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 Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
- •Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.
排除标准
- •Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
- •Patient has a lifetime history of failure to ECT therapy.
- •Patient is pregnant or breast feeding.
- •Length of current episode of depression exceeds ≥2 years.
研究组 & 干预措施
1
Experimental
100 mg iv once per dosing day
干预措施: AZD6765 (Drug)
2
Experimental
150 mg iv once per dosing day
干预措施: AZD6765 (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score
时间窗: Baseline to week 3
次要结局
- To determine if the antidepressant effect can be achieved at week 3 with AZD6765 (100 or 150 mg/infusion) versus placebo by assessing a change from baseline to week 3 in the MADRS total score.(3 weeks)
- To evaluate the rapid antidepressant efficacy of AZD6765 at 1 day after a first infusion, as assessed by a change in the Quick Inventory of Depressive Symptomology Self-Report 16-item scale (QIDS-SR-16) total score.(baseline to Day 1)
- • To assess the safety and tolerability of multiple infusions when administered concomitantly with other anti-depressants by incidence of AEs.(8 weeks)
研究者
研究点 (1)
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