布雷克斯皮普拉和塞特拉林在创伤后应激障碍的联合治疗:一个第三期随机临床试验
Lori L Davis1, Saloni Behl2, Daniel Lee2
1Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham Heersink School of Medicine, Birmingham.
JAMA psychiatry
|December 18, 2024
概括
新的研究表明,将布雷克斯皮普拉与塞特拉林结合起来可以显著改善创伤后应激障碍 (PTSD) 的症状. 这种组合疗法为患有PTSD的个人提供了一个有前途的新治疗选择.
科学领域:
- 精神病学和行为科学
- 临床药理学 临床药理学
- 神经科学是一个神经科学.
背景情况:
- 创伤后应激障碍 (PTSD) 需要新的药物治疗选择.
- 目前对PTSD的治疗有局限性,需要进一步研究替代干预措施.
研究的目的:
- 在患有PTSD的成人门诊患者中,评估与sertraline加安慰剂相比,brexpiprazole和sertraline联合治疗的疗效,安全性和耐受性.
主要方法:
- 一个平行设计,双盲,随机的临床试验,涉及416名患有PTSD的成人门诊患者.
- 参与者接受了口服布雷克斯皮普拉 (2-3毫克/天) 加上塞特拉林 (150毫克/天) 或塞特拉林 (150毫克/天) 加上安慰剂11周.
- 主要结局指标是从随机化到第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:
- 与塞特拉林+安慰剂组相比,布雷克斯皮普拉尔+塞特拉林组在CAPS-5总得分上显示出统计学上显著的更大改善 (LS平均差异: -5.59; P < .001).
- 所有关键的二次疗效终点也得到满足.
- 报告了恶心,疲劳,体重增加和昏昏欲睡等治疗出现的不良事件,在组合组 (3.9%) 与安慰剂组 (10.2%) 的不良事件中,由于不良事件而导致的中止率较低.
结论:
- 与塞特拉林和安慰剂相比,与布雷克斯皮普拉和塞特拉林的联合治疗在改善PTSD症状方面显示出统计学上显著的疗效.
- 这些发现表明,布雷克斯皮普拉+塞特拉林是一种潜在的有效的新型PTSD治疗方法.
- 综合疗法一般耐受良好,安全性与布雷克斯皮普拉的批准适用情况相一致.
相关概念视频
Antidepressant Drugs: MAOIs and Other Agents
194
Atypical antidepressants, including bupropion (Wellbutrin), mirtazapine (Remeron), nefazodone (Serzone), trazodone (Desyrel), and vilazodone (Viibryd), offer unique mechanisms of action. Bupropion weakly inhibits dopamine and norepinephrine reuptake, aiding depression treatment and smoking cessation, with a low risk of sexual dysfunction. Mirtazapine enhances serotonin and norepinephrine neurotransmission, leading to sedation, increased appetite, and weight gain. As a result, it helps treat...
194
Antidepressant Drugs: Tricyclics, SSRIs, and SNRIs
303
Tricyclic Antidepressants (TCAs), including Desipramine (Norpramin), Imipramine (Tofranil), Clomipramine (Anafranil), and Amitriptyline (Elavil), inhibit serotonin and norepinephrine reuptake and also block other receptors. They are used for depression, pain conditions, and insomnia. Common adverse effects include anticholinergic effects, sedation, orthostatic hypotension, and weight gain. They have a narrow therapeutic window and so require plasma-level monitoring. Abrupt discontinuation can...
303
Electroconvulsive Therapy
25
Electroconvulsive therapy (ECT), or shock therapy, remains a critical biomedical intervention for severe, treatment-resistant depression. While its origins can be traced back to Hippocrates' observations that malaria-induced convulsions alleviated mental illness, modern ECT has evolved significantly from its earlier, more primitive applications. First introduced in 1938 by Ugo Cerletti and his colleagues, ECT involves inducing controlled seizures using electrical currents. In its early...
25
Post-traumatic Stress Disorder
27
Post-traumatic stress disorder (PTSD) is a psychiatric condition that arises following exposure to traumatic events such as natural disasters, forced displacement, or severe accidents. It significantly impairs individuals' ability to cope with daily activities and disrupts their emotional and psychological equilibrium.
Symptoms and Behavioral Manifestations
A spectrum of distressing symptoms characterizes PTSD. Recurrent flashbacks, where individuals involuntarily relive traumatic events,...
Symptoms and Behavioral Manifestations
A spectrum of distressing symptoms characterizes PTSD. Recurrent flashbacks, where individuals involuntarily relive traumatic events,...
27


