NCT01234558已完成2 期
Randomized, Double Blind, Placebo Controlled, Single IV Dose Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder
Naurex, Inc, an affiliate of Allergan plc1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2011年5月最近更新:
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
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in depression score
研究概览
简要总结
The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.
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
- •diagnosis of major depressive disorder consistent with DSM-IV-TR
- •current episode greater than 8 weeks in duration
- •Hamilton Depression score >/- 21
- •less than 25% reduction in depression during current episode assessed by ATRQ
排除标准
- •Axis diagnosis of other psychiatric disorders
- •Experiencing hallucinations, delusions, other psychotic symptomatology
- •ECT during current episode
研究组 & 干预措施
Normal Saline
Placebo Comparator
IV placebo
干预措施: GLYX-13 (Drug)
GLYX-13, 1 mg/kg
Experimental
干预措施: GLYX-13 (Drug)
GLYX-13, 5 mg/kg
Experimental
干预措施: GLYX-13 (Drug)
GLYX-13, 10 mg/kg
Experimental
干预措施: GLYX-13 (Drug)
结局指标
主要结局
Change in depression score
时间窗: 14 days
次要结局
- Change in BPRS+(14 days)
研究者
研究点 (1)
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