Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
Clin Drug Investig. 2023 Jun;43(6):383-391. doi: 10.1007/s40261-023-01273-8. Epub 2023 May 24.
Many randomized clinical trials (RCTs) for antidepressants in children and adolescents have failed to demonstrate efficacy due to a high placebo response. The aim of this study was to identify the potential factors affecting placebo response using meta-regression analysis of RCTs for antidepressants in children and adolescents using the Children's Depressive Rating Scale-Revised (CDRS-R) as the outcome.
PubMed and ClinicalTrials.gov were searched for randomized, double-blind, placebo-controlled trials of antidepressants for the acute treatment of major depressive disorder in children and adolescents. The outcome used in the present study was the mean change of the CDRS-R total score from baseline to the last assessment for the primary efficacy in the placebo arm. Potential factors related to the placebo response, such as study design, operational, and patient factors, were explored using meta-regression.
The analyses included 23 trials. On multivariable meta-regression, setting up a placebo lead-in period was significantly associated with a smaller placebo response in the CDRS-R.
Setting up a placebo lead-in period should be considered in future clinical trials of antidepressants in adolescents and children.
由于安慰剂反应较高，许多儿童和青少年抗抑郁药的随机对照试验（RCT）未能显示疗效。本研究旨在通过使用儿童抑郁评定量表修订版（CDRS-R）作为结局，对儿童和青少年抗抑郁药的 RCT 进行荟萃回归分析，以确定影响安慰剂反应的潜在因素。
在 PubMed 和 ClinicalTrials.gov 上搜索了儿童和青少年重度抑郁症急性治疗的抗抑郁药随机、双盲、安慰剂对照试验。本研究使用的结局是安慰剂组主要疗效的 CDRS-R 总分从基线到最后评估的平均变化。使用荟萃回归分析探讨了与安慰剂反应相关的潜在因素，如研究设计、操作和患者因素。
分析包括 23 项试验。在多变量荟萃回归中，设置安慰剂导入期与 CDRS-R 中较小的安慰剂反应显著相关。
在未来的儿童和青少年抗抑郁药临床试验中，应考虑设置安慰剂导入期。
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