Mohammadi Mohammad-Reza, Yadegari Nourrollah, Hassanzadeh Elmira, Farokhnia Mehdi, Yekehtaz Habibeh, Mirshafiee Omid, Akhondzadeh Shahin
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Clin Neuropharmacol. 2013 Nov-Dec;36(6):179-84. doi: 10.1097/WNF.0b013e3182a9339d.
This study aimed to investigate the effect of adding amantadine to risperidone for treatment of autism.
Forty outpatients aged 4 to12 years, who were diagnosed with autism spectrum disorders based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria, were assigned to this double-blind clinical trial. The subjects were divided randomly into 2 groups. One group received risperidone plus amantadine, and the other group received risperidone plus placebo. The dose of risperidone was titrated between 1 and 2.0 mg/d, and the dose of amantadine was 100 or 150 mg/d for patients less than 30 kg or more than 30 kg, respectively. The patients were assessed using the Aberrant Behavioral Checklist-Community (ABC-C) and adverse effects checklist as well as clinical global impression-improvement (CGI-I) at2 checkpoints of 5-week intervals after the baseline. Informed consentwas obtained from the parents of each participant.
Among ABC-C subscales, Hyperactivity and Irritability showed significantly greater reduction in the amantadine group than the placebo group. There was no significant difference in adverse effects between the 2 groups. The CGI-I scores show significant improvement in the amantadine group compared to the placebo group.
The present study suggests that amantadine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated.
本研究旨在探讨在利培酮治疗中添加金刚烷胺对自闭症的治疗效果。
40名年龄在4至12岁之间、根据《精神疾病诊断与统计手册》第四版修订版标准被诊断为自闭症谱系障碍的门诊患者被纳入这项双盲临床试验。受试者被随机分为两组。一组接受利培酮加金刚烷胺治疗，另一组接受利培酮加安慰剂治疗。利培酮剂量在1至2.0毫克/天之间滴定，金刚烷胺剂量对于体重小于30公斤或大于30公斤的患者分别为100或150毫克/天。在基线后的两个间隔为5周的检查点，使用异常行为检查表-社区版（ABC-C）、不良反应检查表以及临床总体印象-改善量表（CGI-I）对患者进行评估。获得了每位参与者父母的知情同意。
在ABC-C分量表中，金刚烷胺组的多动和易激惹症状的减轻程度明显大于安慰剂组。两组之间的不良反应无显著差异。与安慰剂组相比，金刚烷胺组的CGI-I评分显示出显著改善。
本研究表明金刚烷胺可能是一种治疗自闭症的潜在辅助治疗策略，并且其耐受性总体良好。
