Abstract：
Clinical trials in depression lack objective measures. Speech latencies are an objective measure of psychomotor slowing with face validity and empirical support. \'Turn latency\' is the response time between speakers. Retrospective analysis was carried-out on the utility of turn latencies as an enrichment tool in a clinical trial of bipolar I depression. Speech data was obtained from 274 participants during 1,352 Montgomery-Åsberg Depression Rating Scale (MADRS) recordings in a randomized, placebo controlled, 6-week clinical trial of SEP-4199 (200 mg or 400 mg). Post-randomization turn latencies were compared between patients with moderate to severe depression and patients whose depression had remitted. A cutoff was determined and applied to turn latencies pre-randomization to classify individuals into two groups: Speech Latencies Slow (SL-Slow) and Speech Latencies Normal (SL-Normal). At week 6, SL-Slow (N = 172) showed significant separation in MADRS scores between placebo and treatment arms. SL-Normal (N = 102) showed larger MADRS improvements and no significant separation between placebo and treatment arms. Excluding SL-Normal increased primary outcome effect size by 52 % and 100 % for the treatment arms. Turn latencies are an objective measure available from standard clinical assessments and may assess the severity of symptoms more accurately and screen out placebo responders.
摘要：
抑郁症的临床试验缺乏客观措施。言语延迟是通过面部有效性和经验支持来衡量精神运动减慢的客观指标。“转动延迟”是扬声器之间的响应时间。在双相I型抑郁症的临床试验中，对转弯潜伏期作为富集工具的实用性进行了回顾性分析。在随机的1,352个蒙哥马利-奥斯贝格抑郁量表（MADRS）记录中，从274名参与者中获得了语音数据，安慰剂对照，SEP-4199（200mg或400mg）的6周临床试验。在中度至重度抑郁症患者和抑郁症缓解的患者之间比较随机分组后的转折潜伏期。确定了截止值，并将其应用于将延迟预随机化以将个体分为两组：语音延迟慢（SL-慢）和语音延迟正常（SL-正常）。在第6周,SL-Slow(N=172)显示安慰剂组和治疗组之间的MADRS评分的显著分离。SL-正常(N=102)显示更大的MADRS改善,并且安慰剂和治疗组之间没有显著的分离。对于治疗组,排除SL-正常增加了52%和100%的主要结果效应大小。转轮潜伏期是可从标准临床评估获得的客观量度,并且可以更准确地评估症状的严重程度并筛选出安慰剂响应者。
