儿科患者中度至重度重度抑郁症患者的阿戈梅拉丁:一项开放式扩展研究
Celso Arango1, Joerg M Fegert2, Françoise Picarel-Blanchot3
1Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain.
European child & adolescent psychiatry
|October 10, 2024
概括
阿戈梅拉丁在92周的儿科患者中显示出持续的疗效和治疗主要抑郁症 (MDD) 的安全性. 这项研究支持其在青少年和儿童中长期使用中度至重度MDD.
科学领域:
- 精神病学和心理健康 精神病学和心理健康
- 儿科医学 儿科医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 大型抑郁症 (MDD) 在年轻人中很普遍,治疗选择有限.
- 阿戈梅拉丁已在儿科MDD患者中显示出初始的疗效和安全性.
- 一项为期92周的开放式延期研究 (OLE) 评估了阿戈梅拉丁的长期影响.
研究的目的:
- 评估agomelatine在患有中度至重度MDD的儿科患者的长期疗效和安全性.
- 为了评估阿戈梅拉丁在长时间治疗期间的有效性,与安慰剂和克塞丁相比.
主要方法:
- 在一项国际多中心双盲研究中,400名儿科患者被随机分配给12周的阿戈梅拉丁 (10或25毫克),安慰剂或西丁 (10-20毫克).
- 符合条件的患者参加了为期92周的可选开放式延期治疗 (OLE),接受阿戈梅拉丁 (10或25毫克).
- 通过儿童抑郁症评分尺度修订 (CDRS-R) 总得分的变化来衡量有效性;通过不良事件监测安全性.
主要成果:
- 总共有339名患者进入了OLE,在agomelatine治疗组中观察到CDRS-R得分的平均降低 (前/前: -16.3±12.2; pcb/前: -18.9±16.1; fluox/前: -16.1±15.5).
- 与治疗相关的不良事件发生在14.5%的患者中,没有发现意外的安全信号.
- 三名青少年经历了与治疗相关的严重不良事件,导致在一个案例中取消研究.
结论:
- 在患有中度至重度MDD的儿科患者中,阿戈梅拉丁治疗与抑郁症状的持续改善有关.
- 在这个人群中,长期使用到104周的阿戈梅拉丁表明了有利的安全性.
- 研究结果支持继续使用阿戈梅拉丁治疗儿科MDD.
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