Li Huafang, Gu Niufan, Zhang Hongyan, Wang Gang, Tan Qingrong, Yang Fude, Ning Yuping, Zhang Honggeng, Lu Zheng, Xu Xiufeng, Shi Jianguo, Gao Chengge, Li Lingjiang, Zhang Kerang, Tian Hongjun, Wang Xiaoping, Li Keqing, Li Huichun, Xu Yi, Xie Shiping, Yu Xin
Shanghai Mental Health Center, No.600 South Wanping Road, Xuhui District, Shanghai, 200030, China.
Peking University Sixth Hospital, No.51 North Huayuan Rd., Haidian District, Beijing, 100191, China.
Psychopharmacology (Berl). 2016 Apr;233(7):1289-97. doi: 10.1007/s00213-016-4215-z. Epub 2016 Feb 25.
Quetiapine extended release (XR) has been used to treat various psychiatric disorders, including depressive episodes associated with bipolar I and II disorders. Quetiapine XR is the first approved drug in China for the treatment of bipolar disorder.
The study evaluated the efficacy and safety of short-term quetiapine XR monotherapy in the treatment of depressive episodes of bipolar I and II disorders.
This was an 8-week multi-center, randomized, double-blind, placebo-controlled, fixed-dose phase 3 study. The primary endpoint was the mean change of the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary endpoints included Clinical Global Impressions-Bipolar (CGI-BP) and remission rates.
The study recruited 279 adult bipolar I or II patients currently experiencing depression from 11 Chinese provinces. Of these, 139 received quetiapine XR (300 mg/day) and 140 received placebo for 8 weeks. The mean change in the MADRS total score was significantly greater in the quetiapine XR group than in the placebo group (-19.00 ± 7.88 vs. -16.20 ± 9.32; p = 0.004). Adverse events occurred in 96 patients (65.3 %) in the quetiapine XR group and 72 (49.0 %) in the placebo group. The incidence of serious adverse events did not differ significantly between the groups (p = 0.247).
This study, which is the first to evaluate 300 mg/day quetiapine XR monotherapy for depression in Chinese patients with bipolar disorders, found that this drug was superior to the placebo. Quetiapine XR was generally safe and well tolerated (ClinicalTrials.gov number, NCT01256177).
喹硫平缓释片（XR）已被用于治疗各种精神疾病，包括与双相I型和II型障碍相关的抑郁发作。喹硫平XR是中国首个获批用于治疗双相情感障碍的药物。
本研究评估了短期喹硫平XR单药治疗双相I型和II型障碍抑郁发作的疗效和安全性。
这是一项为期8周的多中心、随机、双盲、安慰剂对照、固定剂量的3期研究。主要终点是蒙哥马利-Åsberg抑郁评定量表（MADRS）总分的平均变化。次要终点包括临床总体印象-双相情感障碍（CGI-BP）和缓解率。
该研究从中国11个省份招募了279名目前正在经历抑郁发作的成年双相I型或II型患者。其中，139人接受喹硫平XR（300毫克/天）治疗，140人接受安慰剂治疗8周。喹硫平XR组MADRS总分的平均变化显著大于安慰剂组（-19.00±7.88 vs. -16.20±9.32；p = 0.004）。喹硫平XR组96名患者（65.3%）发生不良事件，安慰剂组72名患者（49.0%）发生不良事件。两组严重不良事件的发生率无显著差异（p = 0.247）。
本研究首次评估了300毫克/天喹硫平XR单药治疗中国双相情感障碍患者抑郁症的疗效，发现该药物优于安慰剂。喹硫平XR总体安全且耐受性良好（ClinicalTrials.gov编号，NCT01256177）。
