这是一项双盲,安慰剂控制,随机抽取的戒断研究,对主要抑郁障碍的辅助布雷克西普拉维护治疗进行了辅助治疗
Roger S McIntyre1, Kripa Sundararajan2, Saloni Behl2
1Brain and Cognition Discovery Foundation and University of Toronto, Toronto, ON, Canada.
Acta neuropsychiatrica
|October 17, 2024
概括
与继续治疗相比,在抗抑郁药治疗 (ADT) 稳定后的大型抑郁症 (MDD) 患者中中止辅助布雷克斯皮普拉的复发率相似. 在这两组中,大约80%的患者没有复发.
科学领域:
- 精神病学是一个精神病学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 大型抑郁症 (MDD) 构成了重大挑战,往往需要组合治疗.
- 与布雷克西普拉结合的抗抑郁药治疗 (ADT) 在稳定MDD症状方面表现出有效性.
- 了解持续辅助治疗与戒断治疗的必要性对于长期管理至关重要.
研究的目的:
- 为了比较稳定在ADT加布雷克西普拉的MDD患者中复发的时间,这些患者被随机分配到继续使用布雷克西普拉或停止使用 (切换到安慰剂).
- 评估在稳定的MDD群体中维持或停止补充布雷克斯皮普拉的疗效和安全性.
主要方法:
- 第三阶段,多中心,双盲,安慰剂控制,随机性戒断研究.
- 招募了患有MDD和对2-3个ADT反应不足的成年人.
- 稳定在ADT + 布雷克斯皮普拉 (2-3毫克/天) 的患者被随机分配继续使用布雷克斯皮普拉或切换到安慰剂26周.
主要成果:
- 在489名随机选择的患者中,240人接受了ADT+布雷克斯皮普拉,249人接受了ADT+安慰剂.
- 在两组中,复发的中位时间相似 (63天).
- 持续使用布雷克斯皮普拉的复发率为22.5%,安慰剂的复发率为20.6% (HR 1.14,p=0.51).
结论:
- 持续补充布雷克西普拉和布雷克西普拉戒断组之间的复发时间是可比的.
- 大约80%的稳定患者在两只手臂的最后一次访问时仍然没有复发.
- 添加布雷克斯皮普拉的耐受性很好,在停用后的副作用很小.
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