Department of Cognitive Neuroscience, University Medical Center, St Radboud and Karakter Child and Adolescent Psychiatry University Center, Nijmegen, The Netherlands.
J Clin Psychiatry. 2012 Aug;73(8):1097-102. doi: 10.4088/JCP.11m07528. Epub 2012 Jun 12.
To find potential correlates of placebo response in adults with attention-deficit/hyperactivity disorder (ADHD) and gain insights into why placebo response may be high in clinical trials.
Post hoc analysis of placebo data from 2 randomized controlled trials of osmotic-release oral system (OROS) methylphenidate in adults with ADHD defined according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition: the Long-Acting Methylphenidate in Adults with ADHD (LAMDA-I) study (2005-2006, 5 weeks, n = 95) and the LAMDA-II study (2008-2009, 13 weeks, n = 97). The primary efficacy measure was the Conners' Adult ADHD Rating Scale-observer rated, short version (CAARS:O-SV). Predictors of CAARS:O-SV change were assessed using a random-intercepts model with demographic and disease-related parameters as independent variables. Sensitivity analyses were conducted using the CAARS self-report (CAARS:S-S) and a categorical response criterion (improvement of > 30% in CAARS:O-SV), and in subjects who completed the study.
In LAMDA-I, mean ± SD change in CAARS:O-SV was -7.6 ± 9.9 with placebo and -11.9 ± 10.6 with OROS methylphenidate. Higher baseline CAARS score (P = .007) and lower educational achievement (P = .014) were significantly associated with greater improvement in placebo-treated subjects. In LAMDA-II, mean ± SD change in CAARS:O-SV was -10.4 ± 11.0 and -14.1 ± 10.7 in subjects receiving placebo and OROS methylphenidate, respectively. Variables significantly associated with greater placebo response were higher baseline CAARS:O-SV (P = .019), shorter time since ADHD diagnosis (P < .045), and younger age (P = .014). None of the sensitivity analyses challenged the outcomes.
Possible predictors of placebo response in adults with ADHD include higher severity of ADHD symptoms, younger age, shorter time since diagnosis, and lower educational level.
寻找成人注意力缺陷/多动障碍（ADHD）中安慰剂反应的潜在相关因素，并深入了解为什么临床试验中安慰剂反应可能很高。
根据《精神疾病诊断与统计手册》第四版（DSM-IV）对成人 ADHD 进行定义，对两项奥昔哌汀控释口服溶液（OROS）哌甲酯随机对照试验的安慰剂数据进行事后分析：长期作用哌甲酯治疗成人 ADHD（LAMDA-I）研究（2005-2006 年，5 周，n = 95）和 LAMDA-II 研究（2008-2009 年，13 周，n = 97）。主要疗效指标为康纳斯成人 ADHD 评定量表-观测者评定，短式（CAARS：O-SV）。使用随机截距模型，将人口统计学和疾病相关参数作为自变量，评估 CAARS：O-SV 变化的预测因素。使用 CAARS 自我报告（CAARS：S-S）和分类反应标准（CAARS：O-SV 改善>30%）以及完成研究的受试者进行敏感性分析。
在 LAMDA-I 中，安慰剂组 CAARS：O-SV 的平均变化±标准差为-7.6±9.9，奥昔哌汀控释口服溶液组为-11.9±10.6。基线 CAARS 评分较高（P =.007）和教育程度较低（P =.014）与安慰剂治疗组的改善显著相关。在 LAMDA-II 中，安慰剂组和奥昔哌汀控释口服溶液组 CAARS：O-SV 的平均变化±标准差分别为-10.4±11.0 和-14.1±10.7。与更大的安慰剂反应显著相关的变量是更高的基线 CAARS：O-SV（P =.019）、ADHD 诊断后时间较短（P <.045）和年龄较小（P =.014）。敏感性分析均未对结果提出质疑。
成人 ADHD 中安慰剂反应的可能预测因素包括 ADHD 症状严重程度较高、年龄较小、诊断后时间较短以及教育程度较低。
