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固定剂量布雷克西普拉和塞特拉林组合治疗创伤后应激障碍:第三阶段,随机试验
Lori L Davis1, Saloni Behl2, Daniel Lee2
1Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham Heersink School of Medicine, Birmingham, AL.
Journal of clinical psychopharmacology
|September 22, 2025
概括
与单独使用塞特拉林相比,固定剂量布雷克西普拉与塞特拉林结合并没有显著改善创伤后应激障碍 (PTSD) 症状. 这一第三阶段试验没有达到其主要终点,尽管没有发现新的安全问题.
科学领域:
- 精神病学是一个精神病学.
- 临床心理学 临床心理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 创伤后应激障碍 (PTSD) 是一种使人虚弱的疾病,通常需要多方面的治疗方法.
- 目前用于PTSD的治疗方法,包括诸如塞特拉林之类的选择性血清素再吸收抑制剂 (SSRI),对某些个体的疗效有局限性.
- 研究新的治疗组合对于改善PTSD管理至关重要.
研究的目的:
- 评估固定剂量布雷克斯皮普拉加塞特拉林与塞特拉林单一治疗在患有PTSD的成年人的疗效和安全性.
- 在一个大型的多站点临床试验中评估这种组合治疗的耐受性.
主要方法:
- 一个第三阶段,随机,双盲,平行臂试验,涉及诊断为PTSD的成年门诊患者.
- 参与者接受了11周的布雷克斯皮普拉 (每天2毫克或3毫克) 加上塞特拉林 (每天150毫克) 或塞特拉林 (每天150毫克) 加上安慰剂治疗.
- 主要结局指标是从基线到第10周的DSM-5 (CAPS-5) 临床医生管理的PTSD尺度总得分的变化.
主要成果:
- 在第10周,brexpiprazole+sertraline组和sertraline+安慰剂组之间没有观察到CAPS-5得分减少的统计学上显著差异.
- 组合治疗组和活跃对照组都显示PTSD症状有所减少.
- 常见的治疗出现的不良事件包括头痛,恶心和腹,在各组发生率相似.
结论:
- 在这项试验中,固定剂量布雷克斯皮普拉与塞特拉林结合并没有在治疗PTSD症状方面表现出比单独治疗塞特拉林更高的疗效.
- 主要终点没有达到,与之前两项研究的发现形成鲜明对比.
- 综合疗法一般耐受良好,没有发现新的安全信号.
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