A double-blind placebo controlled trial of piracetam added to risperidone in patients with autistic disorder
A double-blind placebo controlled trial of piracetam added to risperidone in patients with autistic disorder
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DOI：
10.1007/s10578-007-0084-3
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发表时间：
2008-09-01
影响因子：
2.9
通讯作者：
Ghelichnia, Hossein-Ali
中科院分区：
文献类型：
--
作者：
Akhondzadeh, Shahin;Tajdar, Hamid;Ghelichnia, Hossein-Ali
据报道，自闭症是一种低谷氨酸能障碍。因此，评估AMPA敏感谷氨酸受体的正向调节剂吡拉西坦治疗自闭症的疗效是很有意义的。招募了约40名年龄在3岁至11岁(含)之间、临床诊断为DSM IV自闭症的儿童，他们是一家儿童专科诊所的门诊患者。这些孩子的主诉是与自闭症相关的严重破坏性症状。患者被随机分配到吡拉西坦+利培酮(A组)或安慰剂+利培酮(B组)进行为期10周的双盲安慰剂对照研究。对于10到40公斤的儿童，利培酮的剂量滴定到每天2毫克，对于体重超过40公斤的儿童，每天滴定到3毫克。吡拉西坦的剂量最高可达800毫克/天。患者在基线以及开始服药2、4、6、8和10周后进行评估。采用异常行为检查表-社区(ABC-C)评定量表(总分)评定结果。使用吡拉西坦后，ABC-C评定量表的得分有所提高。两种方案之间的差异有统计学意义(F=5.85，D.F.=1，P=0.02)。A组和B组治疗结束时的变化分别为：-11.90+/-3.79(平均值+/-SD)和-5.15+/-3.04。两组患者第10周ABC-C量表评分变化与治疗前比较，差异有统计学意义(t=6.017，D.F.=38，P<；0.0001)。结果表明，非典型抗精神病药物与谷氨酸类药物如吡拉西坦的结合，可能在自闭症的治疗中具有更强的协同效应。
It has been reported that autism is a hypoglutamatergic disorder. Therefore, it was of interest to assess the efficacy of piracetam, a positive modulator of AMPA-sensitive glutamate receptors in autistic disorder. About 40 children between the ages three and 11 years (inclusive) with a DSM IV clinical diagnosis of autism and who were outpatients from a specialty clinic for children were recruited. The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients were randomly allocated to piracetam + risperidone (Group A) or placebo + risperidone (Group B) for a 10-week, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for children weighting above 40 kg. The dose of piracetam was titrated up to 800 mg/day. Patients were assessed at baseline and after 2, 4, 6, 8 and 10 weeks of starting medication. The measure of the outcome was the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (total score). The ABC-C Rating Scale scores improved with piracetam. The difference between the two protocols was significant as indicated by the effect of group, the between subjects factor (F = 5.85, d.f. = 1, P = 0.02). The changes at the endpoint compared with baseline were: -11.90 +/- 3.79 (mean +/- SD) and -5.15 +/- 3.04 for group A and B respectively. A significant difference was observed on the change in scores in the ABC-C Rating Scale in week 10 compared with baseline in the two groups (t = 6.017, d.f. = 38, P < 0.0001). The results suggest that a combination of atypical antipsychotic medications and a glutamate agent such as piracetam, might have increase synergistic effects in the treatment of autism.