Center for Innovation in Mental Health, Academic Unit of Psychology, Faculty of Environmental and Life Sciences; Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, University of Southampton, UK; Solent NHS Trust, Southampton, UK; New York University Child Study Center; Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, UK.
Anschutz Medical Campus, University of Colorado, Aurora.
J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):213-215. doi: 10.1016/j.jaac.2020.03.009. Epub 2020 Jun 1.
In this issue of the Journal, Blader et al. report the results of a double-blind randomized controlled trial (RCT) aimed at assessing the comparative efficacy and tolerability of adjunctive risperidone (RISP), valproex sodium (DVPX), or placebo for aggressive behaviors in children (aged 6-12 years) with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) or conduct disorder (CD), as well as a prior history of psychostimulant treatment. Participants with aggressive symptoms persisting after an open-label optimization of psychostimulant medication entered the 8-week randomized phase. Weekly sessions of family-based behavioral treatment were offered during both the optimization and the randomized phases. Among the 151 participants who completed the optimization phase (175 were initially enrolled), an unexpected 63.6% met the study criteria for remission, that is, 3 consecutive weeks with subthreshold scores on the Retrospective-Modified Overt Aggression Scale (R-MOAS). Therefore, only 45 participants were eligible for randomization, and 40 (RISP: n = 17; DVPX: n = 14; placebo: n = 9) were included in the primary analysis. Why did JAACAP publish an inconclusive trial? Because, in our view, the lessons that can be learned from this RCT (in particular, from its optimization phase) are highly relevant for both clinicians and trialists in the field. We are confident that the Blader et al. study will contribute to make clinicians in the field more "optimizers" and trialists more "transparent."
在本期《儿科学杂志》上，Blader 等人报告了一项双盲随机对照试验（RCT）的结果，该试验旨在评估利培酮（RISP）、丙戊酸钠（DVPX）或安慰剂作为辅助治疗对伴有注意缺陷多动障碍（ADHD）和共病对立违抗性障碍（ODD）或品行障碍（CD）的 6-12 岁儿童的攻击性行为的疗效和耐受性，以及先前接受过兴奋剂治疗的儿童。在接受开放标签的兴奋剂药物优化治疗后仍有攻击性症状的参与者进入 8 周的随机阶段。在优化和随机阶段都提供了基于家庭的行为治疗课程。在完成优化阶段的 151 名参与者（最初有 175 名参与者）中，有出乎意料的 63.6%符合研究缓解标准，即回溯性改良显性攻击量表（R-MOAS）连续 3 周得分低于阈值。因此，只有 45 名参与者有资格进行随机分组，其中 40 名（RISP：n=17；DVPX：n=14；安慰剂：n=9）被纳入主要分析。为什么 JAACAP 发表了一项不确定的试验？因为在我们看来，该 RCT（尤其是其优化阶段）可以为该领域的临床医生和试验人员提供重要的经验教训。我们相信，Blader 等人的研究将有助于使该领域的临床医生更多地成为“优化者”，试验人员更加“透明”。
