Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks
研究概览
简要总结
The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.
详细描述
Major depressive disorder (MDD) is a common, severe, chronic and often life-threatening illness. Major depression contributes to significant morbidity and mortality. Available pharmacotherapies for major depression are suboptimal in terms of speed of onset, efficacy, and tolerability. Current medications for severe, chronic mood disorders are not based on pathophysiological models of illness, but rather are variation of monoaminergic-based therapies. Org 24448 represents a new treatment approach for depression, by potentiating the AMPA receptor subfamily of ionotropic glutamate receptors. This drug has been shown to have antidepressant features in preclinical models, as well as cognitive-enhancing qualities.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of MDD
- •Have not responded to an adequate trial of one antidepressant in the current episode or have not completed antidepressant trials due to intolerance to ≤3 antidepressant medications in the current or a previous episode
排除标准
- •Presence of psychotic features, OCD, drug or alcohol dependency with the preceding 3 months
研究组 & 干预措施
Placebo
matching placebo pill
干预措施: Placebo (Drug)
Org 24448
ampa receptor potentiator for the treatment of MDD
干预措施: ORG 24448 (Drug)
结局指标
主要结局
mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to 8 weeks
时间窗: at baseline and at 8 weeks
Reduction of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 8 weeks as compared to baseline.
次要结局
- change in neuropsychological function from baseline to 7 weeks(at baseline and at 7 weeks)
研究者
Dennis Charney
Dean
Icahn School of Medicine at Mount Sinai