Authors: Huafang Li Niufan Gu Hongyan Zhang Gang Wang Qingrong Tan Fude Yang Yuping Ning Honggeng Zhang Zheng Lu Xiufeng Xu Jianguo Shi Chengge Gao Lingjiang Li Kerang Zhang Hongjun Tian Xiaoping Wang Keqing Li Huichun Li Yi Xu Shiping Xie Xin Yu
Publish Date: 2016/02/25
Volume: 233, Issue: 7, Pages: 1289-1297
Abstract
This was an 8week multicenter randomized doubleblind placebocontrolled fixeddose phase 3 study The primary endpoint was the mean change of the MontgomeryÅsberg Depression Rating Scale MADRS total score Secondary endpoints included Clinical Global ImpressionsBipolar CGIBP and remission ratesThe 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 −1900 ± 788 vs −1620 ± 932 p = 0004 Adverse events occurred in 96 patients 653 in the quetiapine XR group and 72 490 in the placebo group The incidence of serious adverse events did not differ significantly between the groups p = 0247This 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 ClinicalTrialsgov number NCT01256177
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