在产后抑郁症中使用布雷克萨诺 (SAGE-547注射):随机对照试验
Stephen Kanes1, Helen Colquhoun1, Handan Gunduz-Bruce1
1Sage Therapeutics Inc, Cambridge, MA, USA.
Lancet (London, England)
|June 17, 2017
概括
在第二阶段试验中,布雷克萨诺显著降低了产后抑郁症症状. 这种GABAA受体调节剂为这种严重的情绪障碍提供了有前途的新疗法.
科学领域:
- 神经科学
- 精神病学
- 药理学
背景情况:
- 产后抑郁症 (PPD) 是女性的一种严重情绪障碍,可能与荷尔蒙变化有关.
- 正在研究用于PPD治疗的GABAA受体的阳性基调节剂Allopregnanolone.
研究的目的:
- 评估布雷克萨诺的疗效和安全性,这是一种静脉注射的全孕诺配方,用于治疗严重的产后抑郁症.
主要方法:
- 一个双盲,随机,安慰剂控制的第二阶段试验招募了患有严重PPD的女性.
- 参与者接受了持续60小时的布雷克萨诺或安慰剂静脉输注.
- 主要终点是60小时后汉密尔顿抑郁评分表 (HAM- D) 的变化.
主要成果:
- 与安慰剂相比,Brexanolone在60小时内显示出HAM- D得分的统计显著降低 (p=0. 0075).
- 布雷克萨诺隆的HAM- D得分平均降低了21. 0分,而安慰剂的8. 8分.
- 没有报告严重的不良反应或因不良事件而停止治疗;最常见的副作用是头和昏昏欲睡.
结论:
- 在患有严重产后抑郁症的妇女中,布雷克萨诺输液导致显著且具有临床意义的症状减轻.
- 这些发现支持针对GABAA受体进行PPD治疗.
- 目前正在进行布雷克萨诺隆在PPD中的关键临床项目.
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