青少年注意力缺陷/多动障碍的Centanafadine:一个随机临床试验
Caroline L Ward1, Ann C Childress2, Na Jin1
1Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland.
百纳法丁328.8毫克有效地治疗了青少年的多动症症状,比安慰剂显著改善. 在这项研究中,该药物被发现是安全的,并且耐受性良好.
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.
- 神经科学是一个神经科学.
背景情况:
- 注意缺陷/多动障碍 (ADHD) 是一种影响青少年的神经发育疾病.
- 有效的药理干预对于管理ADHD症状和改善生活质量至关重要.
研究的目的:
- 评估Centanafadine的疗效,安全性和耐受性,这是一种新型的上腺素,多巴胺和血清素再吸收抑制剂.
- 评估Centanafadine在治疗13-17岁青少年的多动症治疗中的有效性.
主要方法:
- 一项随机,双盲,安慰剂对照试验,涉及459名被诊断患有多动症的青少年.
- 参与者每天接受一次的百纳法丁 (164.4毫克或328.8毫克) 或安慰剂6周.
- 主要终点是ADHD评分尺度的变化,第5版 (ADHD-RS-5) 在第6周的总得分.
主要成果:
- 与安慰剂相比,Centanafadine 328.8 mg显著改善了ADHD-RS-5得分 (p = .0006),在第一周就观察到效应.
- 最低剂量,百纳法丁164.4毫克,没有达到主要疗效终点.
- 治疗引起的不良事件通常为轻度至中度,食欲下降,恶心,头痛和皮疹是最常见的.
结论:
- 在328.8毫克的剂量中,Centanafadine在治疗青少年的ADHD中表现出有效性.
- 两种测试的百纳法丁剂量在青少年群体中总体而言是安全的,并且耐受性良好.
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