Mohammadi Mohammad-Reza, Kazemi Mohammad-Reza, Zia Ebtehal, Rezazadeh Shams-Ali, Tabrizi Mina, Akhondzadeh Shahin
Psychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Hum Psychopharmacol. 2010 Nov;25(7-8):560-5. doi: 10.1002/hup.1154. Epub 2010 Dec 8.
The aim of the present study was to further evaluate, under double blind and controlled conditions, the efficacy of amantadine for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents as compared to methylphenidate.
This was a 6-week randomized clinical trial. Forty patients (28 boys and 12 girls) with a DSM-IV-TR diagnosis of ADHD were the study population of this trial. All study subjects were randomly assigned to receive the treatment using capsule of amantadine at a dose of 100-150 mg/day depending on weight (100 mg/day for <30 kg and 150 mg/day for >30 kg) or methylphenidate at a dose of 20-30 mg/day for a 6-week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent Attention deficit/hyperactivity disorder Rating Scale-IV.
No significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores (df = 1; F = 0.02; p = 0.86 and df = 1; F = 0.01; p = 0.89, respectively). Side effects of decreased appetite and restlessness were observed more frequently in the methylphenidate group.
The results of this study indicate that amantadine significantly improved symptoms of ADHD and was well tolerated and it may be beneficial in the treatment of children with ADHD. Nevertheless, the present results do not constitute proof of efficacy.
本研究旨在在双盲和对照条件下,进一步评估金刚烷胺与哌甲酯相比,对儿童和青少年注意力缺陷多动障碍(ADHD)的疗效。
这是一项为期6周的随机临床试验。40例被诊断为ADHD的患者(28名男孩和12名女孩)是该试验的研究对象。所有研究对象被随机分配接受治疗,根据体重,使用剂量为100 - 150毫克/天的金刚烷胺胶囊(体重<30千克者为100毫克/天,体重>30千克者为150毫克/天)或剂量为20 - 30毫克/天的哌甲酯,进行为期6周的双盲随机临床试验。主要结局指标是教师和家长注意力缺陷多动障碍评定量表-IV。
两组在家长和教师评定量表得分上未观察到显著差异(分别为自由度df = 1;F = 0.02;p = 0.86和自由度df = 1;F = 0.01;p = 0.89)。哌甲酯组食欲减退和坐立不安等副作用的发生率更高。
本研究结果表明,金刚烷胺可显著改善ADHD症状,耐受性良好,可能对ADHD儿童的治疗有益。然而,目前的结果并不构成疗效的确证。