使用语音延迟进行丰富,改善了治疗效果的大小在双极性抑郁症的临床试验中
Joshua S Siegel1, Alex S Cohen2, Steven T Szabo3
1Sumitomo Pharmaceuticals Inc; Washington University in St. Louis, Department of Psychiatry.
Psychiatry research
|August 16, 2024
概括
语音延迟,是心理运动减速的客观衡量标准,可以丰富双极性抑郁症的临床试验. 这项分析表明,转延迟可以准确评估症状严重程度并识别安慰剂反应者.
科学领域:
- 精神病学是一个精神病学.
- 临床神经科学 临床神经科学
- 语音分析 语言分析
背景情况:
- 对抑郁症的临床试验往往缺乏对治疗疗效的客观测量.
- 语音延迟,特别是"转延迟" (说话者之间的响应时间),为心理运动减速提供了一个客观的指标.
- 这一指标已经证明了面部有效性和经验支持在评估抑郁症严重程度.
研究的目的:
- 评估转延迟作为双相I型抑郁症临床试验中的丰富工具的实用性.
- 确定随机化前的语音延迟是否可以根据抑郁症严重程度对患者进行分层,并预测治疗反应.
- 评估使用转机延迟排除不响应者对初级结果效应大小的影响.
主要方法:
- 在SEP-4199的6周随机,安慰剂对照试验中,274名参与者的语音数据的回顾性分析.
- 在1352次蒙哥马利-阿斯伯格抑郁评分表 (MADRS) 录音中收集了语音数据.
- 确定了转向延迟的切断值,以将患者分为语音延迟缓慢 (SL-Slow) 和语音延迟正常 (SL-Normal) 组.
主要成果:
- 被归类为SL-Slow (N=172) 的患者在第6周的安慰剂和治疗手臂之间显示出MADRS得分的显著分离.
- 被归类为SL-正常 (N=102) 的患者在没有显著治疗臂分离的情况下显示出更大的MADRS改善.
- 除了SL-正常组,治疗手臂的初级结局效应大小增加了52%和100%.
结论:
- 转延迟是从标准临床评估中得出的客观指标.
- 这一指标可以更准确地评估抑郁症症状严重程度.
- 利用轮番延迟可能会选出安慰剂反应者,从而丰富临床试验人群.
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