作为抗抑郁药物补充剂的数字治疗药物 (CT-152):一个第三阶段随机对照试验 (Mirai研究)
Brian Rothman1, Mary Slomkowski1, Austin Speier2
1Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Dr, Princeton, NJ 08540, USA.
Journal of affective disorders
|May 16, 2025
概括
一种新的数字治疗方法CT-152 (RejoynTM) 在与标准抗抑郁药物一起使用时,显著改善了主要抑郁症 (MDD) 症状. 这种数字疗法 (DTx) 在临床试验中也表现出了有利的安全性.
科学领域:
- 精神病学和行为科学 精神病学和行为科学
- 数字健康创新 数字健康创新
- 药理学辅助剂 药理学辅助剂
背景情况:
- 大型抑郁症 (MDD) 构成了全球重大健康挑战,许多患者对单一治疗反应不足.
- 数字疗法 (DTx) 是一种针对精神疾病的新型干预措施,提供可扩展和可访问的治疗方式.
研究的目的:
- 评估CT-152 (RejoynTM) 的有效性和安全性,这是一种新的数字治疗方法,作为MDD成年人的辅助治疗.
- 评估CT-152在加入现有抗抑郁药物单一治疗时对抑郁症状严重性的影响.
主要方法:
- 一个第三阶段的多中心,随机化,模拟控制试验,涉及386名患有MDD的成年人 (22-64岁) 并对抗抑郁药单一治疗有不充分的反应.
- 参与者接受CT-152 (通过智能手机应用程序进行认知情感和行为干预) 或假装应用程序6周,延长4周. 两组人都继续服用抗抑郁药物.
- 主要结局指标是蒙哥马利-阿斯伯格抑郁评分表 (MADRS) 评分从基线到第6周的变化. 通过治疗出现的不良事件 (TEAE) 来评估安全性.
主要成果:
- 在治疗意图分析 (n=386) 中,CT-152在6周后显示了MADRS得分的统计显著降低,与假药相比 (-2.12差异,P=0.0211).
- 初级疗效分析 (n=354) 显示CT-152有更大的改善趋势 (-9.03比 -7.25),但没有达到统计学意义 (P=0.0568).
- CT-152的耐受性很好,没有因干预而导致的TEAE或停止治疗,也没有报告死亡.
结论:
- 当CT-152 (RejoynTM) 作为辅助治疗时,有效地改善了MDD成年人的抑郁症状.
- 数字治疗药物表现出良好的安全性和耐受性概况.
- 这些发现支持了CT-152的授权,作为FDA第一个处方数字治疗药物,用于辅助MDD治疗.
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