Findling Robert L, Robb Adelaide, Nyilas Margaretta, Forbes Robert A, Jin Na, Ivanova Svetlana, Marcus Ronald, McQuade Robert D, Iwamoto Taro, Carson William H
Department of Child and Adolescent Psychiatry, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106-5080, USA.
Am J Psychiatry. 2008 Nov;165(11):1432-41. doi: 10.1176/appi.ajp.2008.07061035. Epub 2008 Sep 2.
Aripiprazole is a dopamine partial agonist approved for use in adults for short- and long-term treatment of schizophrenia and bipolar disorder. This study was designed to examine the acute efficacy, safety, and tolerability of aripiprazole for adolescents with schizophrenia.
This was a 6-week multicenter, double-blind, randomized, placebo-controlled trial. Subjects 13 to 17 years old with a DSM-IV diagnosis of schizophrenia and a Positive and Negative Syndrome Scale (PANSS) total score of 70 or more were randomly assigned (1:1:1 ratio) to placebo or 10 or 30 mg/day of aripiprazole. The primary endpoint was mean change from baseline to endpoint (last observation carried forward) in PANSS total score. Assessments of safety and tolerability included spontaneously reported adverse events, extrapyramidal symptom scores, serum prolactin concentration, body weight, and metabolic measures.
Of 302 patients, 85% completed the 6-week study. The mean baseline PANSS score was 94.1. At the end of the study, both aripiprazole doses showed statistically significant differences from placebo in reduction in PANSS total score. Adverse events occurring in more than 5% of either aripiprazole group and with a combined incidence at least twice the rate for placebo were extrapyramidal disorder, somnolence, and tremor. Mean changes in prolactin were -8.45, -11.93, and -15.14 ng/ml for placebo and 10 mg and 30 mg of aripirazole, respectively. Mean body weight changes were -0.8, 0.0, and 0.2 kg for placebo and 10 mg and 30 mg of aripiprazole, respectively.
Both 10- and 30-mg/day doses of aripiprazole were superior to placebo in the acute treatment of adolescents with schizophrenia. Aripiprazole was generally well tolerated.
阿立哌唑是一种多巴胺部分激动剂，已被批准用于成人精神分裂症和双相情感障碍的短期及长期治疗。本研究旨在考察阿立哌唑治疗青少年精神分裂症的急性疗效、安全性及耐受性。
这是一项为期6周的多中心、双盲、随机、安慰剂对照试验。将年龄在13至17岁、符合DSM-IV精神分裂症诊断标准且阳性和阴性症状量表（PANSS）总分达70分及以上的受试者按1:1:1比例随机分配至安慰剂组或阿立哌唑10 mg/天或30 mg/天组。主要终点为PANSS总分从基线到终点（末次观察结转）的平均变化。安全性和耐受性评估包括自发报告的不良事件、锥体外系症状评分、血清催乳素浓度、体重及代谢指标。
302例患者中，85%完成了为期6周的研究。PANSS基线平均分为94.1。研究结束时，阿立哌唑两个剂量组在降低PANSS总分方面与安慰剂相比均有统计学显著差异。阿立哌唑组中发生率超过5%且合并发生率至少为安慰剂组两倍的不良事件为锥体外系疾病、嗜睡和震颤。安慰剂组、阿立哌唑10 mg组和30 mg组催乳素的平均变化分别为-8.45、-11.93和-15.14 ng/ml。安慰剂组、阿立哌唑10 mg组和30 mg组体重的平均变化分别为-0.8、0.0和0.2 kg。
阿立哌唑10 mg/天和30 mg/天剂量在青少年精神分裂症的急性治疗中均优于安慰剂。阿立哌唑总体耐受性良好。
