治疗耐药性抑郁症患者的口服乙胺:双盲,随机,安慰剂对照试验与开放标签扩展
Sanne Y Smith-Apeldoorn1, Jolien K E Veraart2,3, Jeanine Kamphuis2
1Department of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. s.y.apeldoorn@umcg.nl.
Molecular psychiatry
|March 25, 2024
概括
固定的低剂量口服乙胺并没有改善治疗耐药患者的抑郁症症状. 然而,单独定位较高剂量的口服乙胺在后期阶段显示出潜在的抗抑郁作用.
科学领域:
- 药理学 药理学是指药理学的学科.
- 精神病学是一个精神病学.
- 临床试验 临床试验
背景情况:
- 抑郁症影响了许多人,其中很大一部分对现有治疗没有反应.
- 静脉和鼻内胺显示抗抑郁作用,但面临着可访问性挑战.
- 口服乙胺为治疗抑郁症提供了一个潜在的更具可扩展性的替代方案.
研究的目的:
- 评估治疗耐药性抑郁症 (TRD) 患者口服乙胺的疗效,安全性和耐受性.
- 在一项随机对照试验中,将固定的低剂量口服乙胺与安慰剂进行比较.
- 探索在开放式延长阶段单独定位较高剂量的口服乙胺的效果.
主要方法:
- 一个随机的安慰剂对照试验与一个开放的标签扩展,涉及111名参与者与TRD.
- 第一个阶段:六周固定低剂量口服乙胺 (30毫克三次每天) 或安慰剂.
- 第二阶段:四周的洗期,然后是可选的六周的开放阶段,单独定位的口服乙胺 (0.53.0 mg/kg两次).
主要成果:
- 与安慰剂 (p=0.626) 相比,固定低剂量口服乙胺在汉密尔顿抑郁评分表 (HDRS17) 评分中没有显著改善.
- 没有观察到安全性和耐受性的显著差异,除了在胺组中增加头和睡眠幻觉.
- 在开放阶段,单独定位的口服乙胺显著降低了HDRS17平均得分 (从21.0到15.1,p<0.001).
结论:
- 固定的低剂量口服乙胺对治疗TRD没有效果.
- 单独定位的较高剂量的口服乙胺可能具有抗抑郁作用.
- 在TRD中对口服乙胺的优化剂量策略进行进一步的研究是有必要的.
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