Department of Psychiatry, Tokai University School of Medicine, Kanagawa, Japan.
Institute of CNS Pharmacology, Tokyo, Japan.
Psychiatry Clin Neurosci. 2018 Sep;72(9):701-712. doi: 10.1111/pcn.12681. Epub 2018 Jul 2.
The purpose of this study was to evaluate the safety and efficacy of aripiprazole in adolescents with schizophrenia (SCZ) in Japan.
In a 6-week, randomized, double-blind, dose-comparison study, adolescents (aged 13-17 years) with SCZ were randomized to receive aripiprazole 2, 6-12, or 24-30 mg/day. Patients who completed the 6-week study participated in a 52-week, flexible-dose, open-label extension (OLE) study of aripiprazole (initial dose: 2 mg/day, maintenance dose: 6-24 mg/day, maximum dose: 30 mg/day).
In the 6-week study, the percentage of patients completing treatment was: 77.1% (27/35) for 2 mg/day; 80.0% (24/30) for 6-12 mg/day; and 85.4% (35/41) for 24-30 mg/day. The least squares mean change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint (primary efficacy endpoint, last observation carried forward) was -19.6 for 2 mg/day, -16.5 for 6-12 mg/day, and - 21.6 for 24-30 mg/day. The most common (≥20% patients in any group) treatment-emergent adverse events (TEAE) were nausea, akathisia, insomnia, and somnolence. Most TEAE were mild or moderate in severity. There were no deaths. In the OLE, 60.3% (41/68) of patients completed treatment, and the PANSS total score decreased by -7.9 from OLE baseline to week 52. The most common (≥20% patients) TEAE were nasopharyngitis and somnolence. Most TEAE were mild or moderate in severity. There were no deaths.
These study results suggest that aripiprazole would be safe and well tolerated in both short- and long-term treatment for adolescents with SCZ in Japan.
本研究旨在评估阿立哌唑在日本青少年精神分裂症（SCZ）患者中的安全性和疗效。
在一项为期 6 周、随机、双盲、剂量比较的研究中，将符合 SCZ 诊断标准的青少年（年龄 13-17 岁）随机分为阿立哌唑 2、6-12 或 24-30mg/日组。完成 6 周研究的患者参加了一项为期 52 周、灵活剂量、开放标签延伸（OLE）研究，阿立哌唑的起始剂量为 2mg/日，维持剂量为 6-24mg/日，最大剂量为 30mg/日。
在 6 周的研究中，完成治疗的患者比例分别为：2mg/日组为 77.1%（27/35）；6-12mg/日组为 80.0%（24/30）；24-30mg/日组为 85.4%（35/41）。从基线到终点（主要疗效终点，末次观察值结转），阳性和阴性症状量表（PANSS）总分的最小二乘均值变化分别为：2mg/日组为-19.6；6-12mg/日组为-16.5；24-30mg/日组为-21.6。最常见（任何一组发生率≥20%）的治疗中出现的不良事件（TEAE）为恶心、静坐不能、失眠和嗜睡。大多数 TEAE 为轻度或中度。无死亡事件。在 OLE 中，60.3%（41/68）的患者完成了治疗，PANSS 总分从 OLE 基线到第 52 周下降了-7.9。最常见（发生率≥20%）的 TEAE 为鼻咽炎和嗜睡。大多数 TEAE 为轻度或中度。无死亡事件。
这些研究结果表明，阿立哌唑在日本青少年精神分裂症患者的短期和长期治疗中均安全且耐受良好。
