l -肉碱辅助利培酮治疗自闭症谱系障碍相关行为:随机双盲临床试验。

IF 2.1 3区 医学 Q3 PHARMACOLOGY & PHARMACY International Clinical Psychopharmacology Pub Date : 2024-07-01 Epub Date: 2023-08-07 DOI:10.1097/YIC.0000000000000496
Mehry Nasiri, Zohal Parmoon, Yalda Farahmand, Ali Moradi, Kimia Farahmand, Kamyar Moradi, Fatemeh A Basti, Mohammad-Reza Mohammadi, Shahin Akhondzadeh
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引用次数: 0

摘要

本研究旨在评估左旋肉碱作为利培酮的辅助药物治疗自闭症谱系障碍(ASD)相关行为的有效性和安全性。在这项研究中,68名确诊患有自闭症谱系障碍的儿童被随机分配到在利培酮治疗的同时接受左旋肉碱(150毫克/天)或匹配的安慰剂治疗。我们使用异常行为检查表-社区版量表(ABC-C)和潜在不良反应检查表来评估试验第0周、第5周和第10周的行为状态变化和安全性概况。主要结果定义为烦躁子量表得分的变化。基线特征相似的 60 名患者完成了试验。虽然在试验期间,两组患者的ABC-C分量表得分都有显著下降,但与利培酮和安慰剂组合相比,左旋肉碱和利培酮组合在易激惹和多动分量表上的降幅更大(P = 0.033和P = 0.033)。
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l -carnitine adjunct to risperidone for treatment of autism spectrum disorder-associated behaviors: a randomized, double-blind clinical trial.

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.

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来源期刊
CiteScore
4.40
自引率
23.10%
发文量
97
审稿时长
>12 weeks
期刊介绍: International Clinical Psychopharmacology provides an essential link between research and clinical practice throughout psychopharmacology. It reports on studies in human subjects, both healthy volunteers and patients, which relate the effects of drugs on psychological processes. A major objective of the journal is to publish fully refereed papers which throw light on the ways in which the study of psychotropic drugs can increase our understanding of psychopharmacology. To this end the journal publishes results of early Phase I and II studies, as well as those of controlled clinical trials of psychotropic drugs in Phase II and IV. Other topics covered include the epidemiology of psychotropic drug prescribing and drug taking, the sociology of psychotropic drugs including compliance, and research into the safety and adverse effects of these compounds.
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