长达52周的开放标签安全性和耐受性研究,研究了在注意力缺陷/多动症障碍的成年人中持续释放的Centanafadine
Gregory W Mattingly1, Osman Turkoglu2, Denise Chang2
1Washington University School of Medicine, Midwest Research Group, St. Louis, MO.
持续释放的Centanafadine (CTN SR) 在52周的时间内在患有ADHD的成年人中证明了安全性和有效性. 这种北上腺素,多巴胺和血清素再吸收抑制剂 (NDSRI) 显示症状有所改善,副作用可控.
科学领域:
- 神经科学是一个神经科学.
- 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.
背景情况:
- 百纳法丁 (CTN) 是一种新型的上腺素,多巴胺和血清素再吸收抑制剂 (NDSRI).
- CTN正在开发成人注意力缺陷/多动症 (ADHD) 治疗.
- 这项研究评估了CTN持续释放 (SR) 的长期安全性,耐受性和有效性.
研究的目的:
- 评估CTN SR在52周的ADHD成年人中的安全性和耐受性.
- 探索CTN SR在治疗成人多动症症状中的有效性.
- 评估CTN SR.的长期治疗概况.
主要方法:
- 成年参与者在一个开放的标签研究中每天接受CTN SR400毫克,持续52周.
- 安全性评估包括不良事件,实验室,生命体征,心电图和自杀率等级.
- 探索性疗效使用成人调查者症状评分表 (AISRS) 和CGI-S.进行测量.
主要成果:
- 招募了662名成年人;345人完成了52周的试验.
- 最常见的治疗出现的不良事件 (TEAE) 是失眠,恶心,腹和头痛,大多是轻度/中度.
- 在AISRS总分 (高达57%) 和CGI-S (-1.5分) 中观察到显著改善.
结论:
- 在成年人中,CTN SR 400 mg是长期ADHD治疗的安全和耐受药物.
- 该药物在减少ADHD症状严重程度方面表现出显著的有效性.
- 结果支持CTN SR作为成人ADHD的潜在长期治疗选择.
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