Efficacy and safety of add-on dextromethorphan on irritability in children with ADHD treated with methylphenidate: A randomized double-blind controlled trial

IF 4.9 2区医学 Q1 CLINICAL NEUROLOGY

Journal of affective disorders Pub Date : 2025-05-27 DOI:10.1016/j.jad.2025.119546

Pei-Yin Pan, Chin-Bin Yeh

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引用次数: 0

Abstract

Objective

Converging evidence suggests that childhood irritability is prospectively associated with major depressive disorder. Dextromethorphan has shown efficacious in improving depressive symptomatology in adults. This trial aimed to investigate the efficacy and safety of add-on dextromethorphan on irritability in children with attention-deficit/hyperactivity disorder (ADHD) receiving methylphenidate treatment.

Methods

This randomized, double-blind, parallel-group trial evaluated dextromethorphan/methylphenidate versus placebo/methylphenidate in patients 7–17 years old with ADHD and comorbid irritability, which defined by the score of the Affective Reactivity Index (ARI) parent-report form ≥6. Patients were randomly assigned to receive optimal dose of methylphenidate and either dextromethorphan or placebo, 30 mg once daily for the first 2 weeks and 60 mg once daily thereafter, for a total of 8 weeks. The primary outcome was the change from baseline to week 8 in the ARI score.

Results

A total of 19 patients were randomized (dextromethorphan, N = 8; placebo, N = 11), and Dextromethorphan was significantly superior to the placebo in reducing the ARI score at Week 2 (−5.82 points vs. −0.32 points; least-squares mean difference − 5.50; 95 % CI −8.13, −2.87), Week 4 (−6.49 points vs. −1.96 points; least-squares mean difference − 4.53; 95 % CI −7.13, −1.94), and Week 8 (−4.98 points vs. −2.21 points; least-squares mean difference − 2.77; 95 % CI −5.29, −0.24). The effects of treatment by time interaction were significant at week 2, week 4, and week 8 (p < 0.001, p < 0.001, and p = 0.015, respectively).

Conclusions

Adjunctive dextromethorphan might be efficacious in the treatment of irritability in children with ADHD treated with methylphenidate.

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加用右美沙芬治疗哌醋甲酯治疗多动症儿童易怒的疗效和安全性：一项随机双盲对照试验

目的越来越多的证据表明，儿童易怒可能与重度抑郁症有关。右美沙芬对改善成人抑郁症状有效。本试验旨在探讨加用右美沙芬对接受哌醋甲酯治疗的注意缺陷/多动障碍（ADHD）儿童易怒的疗效和安全性。方法本随机、双盲、平行组试验评估右美沙芬/哌醋甲酯与安慰剂/哌醋甲酯对7-17岁ADHD伴共病易怒患者的治疗效果，共病易怒以情感反应指数（ARI）家长报告评分≥6为标准。患者被随机分配接受最佳剂量的哌甲酯和右美沙芬或安慰剂，前2周每天30毫克，之后每天60毫克，共8周。主要结果是ARI评分从基线到第8周的变化。结果随机抽取19例患者(右美沙芬，N = 8；右美沙芬在第2周降低ARI评分方面显著优于安慰剂(- 5.82分vs - 0.32分；最小二乘均差−5.50；95% CI - 8.13, - 2.87)，第4周(- 6.49点对- 1.96点；最小二乘均差−4.53；95% CI - 7.13, - 1.94)和第8周(- 4.98点对- 2.21点；最小二乘均差−2.77；95% ci - 5.29, - 0.24)。时间交互作用对治疗的影响在第2周、第4周和第8周显著(p <；0.001, p <；0.001, p = 0.015)。结论右美沙芬联用治疗哌醋甲酯治疗ADHD患儿的易怒症状可能有效。

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来源期刊

Journal of affective disorders 医学-精神病学

CiteScore

10.90

自引率

6.10%

发文量

1319

审稿时长

9.3 weeks

期刊介绍： The Journal of Affective Disorders publishes papers concerned with affective disorders in the widest sense: depression, mania, mood spectrum, emotions and personality, anxiety and stress. It is interdisciplinary and aims to bring together different approaches for a diverse readership. Top quality papers will be accepted dealing with any aspect of affective disorders, including neuroimaging, cognitive neurosciences, genetics, molecular biology, experimental and clinical neurosciences, pharmacology, neuroimmunoendocrinology, intervention and treatment trials.