恢复TADS:RIAT对患有抑郁症的青少年治疗的重新分析研究
Natalie Aboustate1, Jon Jureidini1, Richard Woodman2
1Critical and Ethical Mental Health research group, Robinson Research Institute, The University of Adelaide, Adelaide SA, Australia.
概括
对青少年抑郁症治疗研究 (TADS) 的重新分析发现,组合治疗 (fluoxetine加CBT) 对青少年抑郁症最有效. 然而,单独使用fluoxetine的危害增加,包括未报告的与自杀有关的事件,因此需要谨慎.
科学领域:
- 精神病学是一个精神病学.
- 临床心理学 临床心理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 青少年抑郁症治疗研究 (TADS) 显著影响了青少年抑郁症的当前临床实践指南.
- 进行了恢复隐形和废弃试验 (RIAT) 主导的再分析,以重新评估TADS的有效性和安全性.
研究的目的:
- 根据TADS试验数据,重新评估青少年抑郁症治疗的疗效和安全性.
- 为了比较单独使用fluoxetine (FLX),单独使用认知行为疗法 (CBT),组合疗法 (COMB) 和安慰剂 (PBO).
主要方法:
- 一项涉及439名青少年的第三阶段,多中心,随机对照试验的重新分析.
- 参与者被随机分配到FLX,CBT,COMB或PBO12周.
- 主要结局包括儿童抑郁评分尺度修订 (CDRS-R) 和临床全球印象改善尺度 (CGI-I).
主要成果:
- 与PBO和CBT相比,组合疗法 (COMB) 显示CDRS-R显著下降,但FLX没有.
- COMB显示了CGI-I响应者的比例高于所有其他组;FLX显示了比PBO更多的响应者.
- 在接受西治疗的组中,不良事件更为频繁,有32个严重不良事件 (22在西组),其中包括11个未报告的与自杀有关的事件.
结论:
- 重新分析证实COMB具有最强大的结果,FLX不优于PBO.
- 与最初的报告相反,重新分析显示,与素相关的危害发生率较高.
- 增加的伤害,包括与自杀有关的事件,在为青少年抑郁症开药时需要谨慎.
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