Jensen Jonathan B, Kumra Sanjiv, Leitten Willa, Oberstar Joel, Anjum Afshan, White Tonya, Wozniak Jeffrey, Lee Susanne S, Schulz S Charles
University of Minnesota, Department of Psychiatry, Minneapolis, Minnesota 55454, USA.
J Child Adolesc Psychopharmacol. 2008 Aug;18(4):317-26. doi: 10.1089/cap.2007.0123.
There is a limited evidence base to guide treatment of children and adolescents with nonaffective psychoses because few comparative studies of first-line second-generation antipsychotics (SGAs) have been undertaken. To plan the design of a subsequent randomized controlled trial (RCT), the authors conducted this pilot study to demonstrate the feasibility of the treatment and measurement protocols.
Thirty children and adolescents (20 males, 10 females), ages 10-18 years, who met unmodified Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for a schizophrenia-spectrum disorder (schizophrenia, schizoaffective, schizophreniform, psychotic disorder not otherwise specified) were randomized to receive 12 weeks of open-label, flexibly dosed treatment with either risperidone (mean [standard deviation, SD] dose = 3.4 mg [1.5]), olanzapine (mean [SD] dose = 14.0 mg [4.6]) or quetiapine (mean [SD] dose = 611 mg [253.4]).
Twenty one (70%) of 30 subjects completed the study. There was no overall statistically significant difference with regard to reduction in Positive and Negative Syndrome Scale (PANSS) total scores in treatment efficacy observed (F((2,24)) = 3.13, p = 0.06). However, the possibility of a large differential treatment effect with regard to change in PANSS total scores favoring risperidone relative to quetiapine (risperidone vs. quetiapine, d = 1.10 [95% confidence interval, CI, 0.09-2.01]) was suggested by the point estimate.
These preliminary data, viewed together with the extant literature, suggest that a future larger RCT with only two treatment arms may be warranted to establish whether there is a clinically significant differential treatment effect between risperidone and quetiapine for children and adolescents with nonaffective psychoses. Additional challenges and considerations for mounting a larger RCT are explored.
由于针对一线第二代抗精神病药物（SGA）的比较研究较少，因此指导儿童和青少年非情感性精神病治疗的证据基础有限。为了规划后续随机对照试验（RCT）的设计，作者开展了这项初步研究以证明治疗和测量方案的可行性。
30名年龄在10至18岁之间、符合未经修订的《精神障碍诊断与统计手册》第四版（DSM-IV）精神分裂症谱系障碍（精神分裂症、分裂情感性障碍、精神分裂症样障碍、未另行规定的精神病性障碍）标准的儿童和青少年（20名男性，10名女性）被随机分配，接受为期12周的开放标签、灵活剂量的利培酮（平均[标准差，SD]剂量 = 3.4毫克[1.5]）、奥氮平（平均[SD]剂量 = 14.0毫克[4.6]）或喹硫平（平均[SD]剂量 = 611毫克[253.4]）治疗。
30名受试者中有21名（70%）完成了研究。在观察到的治疗效果方面，阳性和阴性症状量表（PANSS）总分降低情况无总体统计学显著差异（F((2,24)) = 3.13，p = 0.06）。然而，点估计表明，PANSS总分变化方面存在较大差异治疗效果的可能性，即相对于喹硫平，利培酮更具优势（利培酮与喹硫平相比，d = 1.10 [95%置信区间，CI，0.09 - 2.01]）。
这些初步数据与现有文献一起表明，未来可能需要开展一项仅包含两个治疗组的更大规模RCT，以确定利培酮和喹硫平对儿童和青少年非情感性精神病患者是否存在临床上显著的差异治疗效果。探讨了开展更大规模RCT的其他挑战和注意事项。
