OBJECTIVE Despite the clinical importance of chronic and severe irritability, there is a paucity of controlled trials for its pharmacological treatment. Here, we examine the effects of adding citalopram (CTP) to methylphenidate (MPH) in the treatment of chronic severe irritability in youth using a double-blind randomized placebo-controlled design. METHOD After a lead-in phase of open treatment with stimulant, 53 youth meeting criteria for severe mood dysregulation (SMD) were randomly assigned to receive CTP or placebo (PBO) for 8 weeks. A total of 49 participants, 48 of them (98%) meeting disruptive mood dysregulation disorder (DMDD) criteria, were included in the intent-to-treat analysis. The primary outcome measure was the proportion of response based on improvements of irritability at the week 8 of the trial. RESULTS At the end of the trial, a significantly higher proportion of response was seen in those participants randomly assigned to CTP+MPH compared to PBO+MPH (35% CTP+MPH versus 6% PBO+MPH; odds ratio = 11.70, 95% CI = 2.00-68.16, p = 0.006). However, there were no differences in functional impairment between groups at the end of the trial. No differences were found in any adverse effect between treatment groups, and no trial participant exhibited hypomanic or manic symptoms. CONCLUSION Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone. CLINICAL TRIAL REGISTRATION INFORMATION A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation; https://clinicaltrials.gov; NCT00794040.

中文翻译：

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一项双盲随机安慰剂对照试验西酞普兰辅助慢性严重易激惹的青少年兴奋剂药物。

目的 尽管慢性和严重的易激惹具有临床重要性，但其药物治疗的对照试验却很少。在这里，我们使用双盲随机安慰剂对照设计检查将西酞普兰 (CTP) 添加到哌醋甲酯 (MPH) 中治疗青少年慢性严重易激惹的效果。方法 在兴奋剂开放治疗的导入阶段后，53 名符合严重情绪失调 (SMD) 标准的青少年被随机分配接受 CTP 或安慰剂 (PBO) 治疗 8 周。共有 49 名参与者，其中 48 名 (98%) 符合破坏性情绪失调障碍 (DMDD) 标准，被纳入意向治疗分析。主要结果指标是基于试验第 8 周易激惹改善的反应比例。结果 在试验结束时，与 PBO+MPH 相比，随机分配到 CTP+MPH 的参与者的反应比例明显更高（35% CTP+MPH 对比 6% PBO+MPH；比值比 = 11.70，95% CI = 2.00-68.16，p = 0.006）。然而，在试验结束时，各组之间的功能障碍没有差异。治疗组之间的任何不良反应均未发现差异，并且没有试验参与者表现出轻度躁狂或躁狂症状。结论 辅助 CTP 可能有效治疗对单独兴奋剂治疗有抵抗力的青少年的慢性严重易激惹。临床试验注册信息 将 5-羟​​色胺再摄取抑制剂添加到患有严重情绪失调的青年的兴奋剂药物中的对照试验；https://clinicaltrials.gov；NCT00794040。