Nasiri Mehry, Parmoon Zohal, Farahmand Yalda, Moradi Ali, Farahmand Kimia, Moradi Kamyar, Basti Fatemeh A, Mohammadi Mohammad-Reza, Akhondzadeh Shahin
Psychiatric Research Center, Roozbeh Psychiatric Hospital.
School of Medicine, Tehran University of Medical Sciences.
Int Clin Psychopharmacol. 2024 Jul 1;39(4):232-239. doi: 10.1097/YIC.0000000000000496. Epub 2023 Aug 7.
The present study was designed to evaluate the efficacy and safety of l-carnitine as an adjuvant agent to risperidone in the treatment of autism spectrum disorder (ASD)-associated behaviors. In this study, 68 children with confirmed ASD were randomly allocated to receive either l-carnitine (150 mg/day) or matched placebo in addition to risperidone. We utilized the Aberrant Behavior Checklist-Community Edition scale (ABC-C) and a checklist of potential adverse effects to assess changes in behavioral status and safety profile at weeks 0, 5 and 10 of the trial. The primary outcome was defined as a change in the irritability subscale score. Sixty patients with similar baseline characteristics completed the trial period. Although scores of ABC-C subscales significantly decreased in both groups over the trial period, the combination of l-carnitine and risperidone resulted in more reduction on the irritability and hyperactivity subscales compared to the combination of risperidone and placebo ( P = 0.033 and P < 0.001, respectively). However, changes in lethargy, stereotypic behavior and inappropriate speech subscales were similar between groups. In conclusion, l-carnitine adjuvant to risperidone could improve irritability and hyperactivity features in children with ASD. Results of this study should be considered preliminary and further clinical trials with larger sample sizes and longer follow-up periods are warranted.
本研究旨在评估左旋肉碱作为利培酮辅助药物治疗自闭症谱系障碍（ASD）相关行为的疗效和安全性。在本研究中，68名确诊为ASD的儿童被随机分配，除接受利培酮治疗外，分别给予左旋肉碱（150毫克/天）或匹配的安慰剂。我们使用异常行为检查表社区版量表（ABC-C）和一份潜在不良反应检查表，在试验的第0、5和10周评估行为状态和安全性的变化。主要结局定义为易激惹分量表得分的变化。60名具有相似基线特征的患者完成了试验期。尽管在试验期间两组的ABC-C分量表得分均显著降低，但与利培酮和安慰剂联合用药相比，左旋肉碱与利培酮联合用药在易激惹和多动分量表上的降低幅度更大（分别为P = 0.033和P < 0.001）。然而，两组在嗜睡、刻板行为和不当言语分量表上的变化相似。总之，左旋肉碱辅助利培酮可改善ASD儿童的易激惹和多动特征。本研究结果应被视为初步结果，有必要进行更大样本量和更长随访期的进一步临床试验。
