Cohen David, Consoli Angèle, Bodeau Nicolas, Purper-Ouakil Diane, Deniau Emmanuelle, Guile Jean-Marc, Donnelly Craig
Department of Child and Adolescent Psychiatry, Université Pierre et Marie Curie, GH Pitié-Salpétrière, AP-HP, Paris, France.
J Child Adolesc Psychopharmacol. 2010 Feb;20(1):39-47. doi: 10.1089/cap.2009.0047.
The aim of this study was to assess predictors of placebo response in all available short-term, placebo-controlled trials of psychotropic drugs for children and adolescents with internalizing disorders, major depressive disorder (MDD), obsessive compulsive disorder (OCD,) and anxiety disorders (ANX) exclusive of OCD and posttraumatic stress disorder (PTSD).
We reviewed the literature relevant to the use of psychotropic medication in children and adolescents with internalizing disorders, restricting our review to double-blind studies including a placebo arm. Placebo response, defined according to each trial's primary response outcome variable and Clinical Global Impressions-Improvement, when available, and potential predictive variables were extracted from 40 studies.
From 1972 to 2007, we found 23 trials that evaluated the efficacy of psychotropic medication involving youth with MDD, 7 pertaining to youths with OCD, and 10 pertaining to youths with ANX (N = 2,533 patients in placebo arms). For all internalizing disorders combined, predictors of nonresponse to placebo were the percentage of Caucasian patients included in the study and the duration of the disorder: Both variables were negatively correlated with the percent of placebo responders. The type of disorder was found to predict the robustness of placebo response: (OCD < ANX < MDD). For a subset of MDD studies, we found that baseline illness severity tended to be negatively correlated with placebo response. Finally, trial "success" was significantly associated with lower placebo response rate.
Predictors of placebo response in internalizing disorders of youths parallel those in adult studies, with the exception of race. These predictors should be considered when designing placebo-controlled trials in youths to enhance findings of true drug-placebo differences.
本研究旨在评估在所有现有的针对患有内化性障碍、重度抑郁症（MDD）、强迫症（OCD）以及不包括强迫症和创伤后应激障碍（PTSD）的焦虑症（ANX）的儿童和青少年的精神药物短期安慰剂对照试验中，安慰剂反应的预测因素。
我们回顾了与使用精神药物治疗患有内化性障碍的儿童和青少年相关的文献，将我们的回顾限制在包括安慰剂组的双盲研究。根据每个试验的主要反应结果变量和临床总体印象改善情况（如可用）定义安慰剂反应，并从40项研究中提取潜在的预测变量。
从1972年到2007年，我们发现23项试验评估了精神药物对患有MDD的青少年的疗效，7项涉及患有OCD的青少年，10项涉及患有ANX的青少年（安慰剂组中有2533名患者）。对于所有合并的内化性障碍，对安慰剂无反应的预测因素是研究中白人患者的百分比和疾病持续时间：这两个变量与安慰剂反应者的百分比均呈负相关。发现障碍类型可预测安慰剂反应的强度：（OCD < ANX < MDD）。对于一部分MDD研究，我们发现基线疾病严重程度往往与安慰剂反应呈负相关。最后，试验“成功”与较低的安慰剂反应率显著相关。
青少年内化性障碍中安慰剂反应的预测因素与成人研究中的相似，但种族除外。在设计针对青少年的安慰剂对照试验时应考虑这些预测因素，以增强真正药物与安慰剂差异的研究结果。
