Huafang Li1, Niufan Gu1, Hongyan Zhang2, Gang Wang3, Qingrong Tan4, Fude Yang5, Yuping Ning6, Honggeng Zhang7, Zheng Lu8, Xiufeng Xu9, Jianguo Shi10, Chengge Gao11, Lingjiang Li12, Kerang Zhang13, Hongjun Tian14, Xiaoping Wang15, Keqing Li16, Huichun Li17, Yi Xu18, Shiping Xie19, Xin Yu20. 1. Shanghai Mental Health Center, No.600 South Wanping Road, Xuhui District, Shanghai, 200030, China. 2. Peking University Sixth Hospital, No.51 North Huayuan Rd., Haidian District, Beijing, 100191, China. 3. Beijing An Ding Hospital, Capital Medical University, No.5 An Kang Hutong Deshengmen wai, Xicheng District, Beijing, 100008, China. 4. Xijing Hospital, No.127 Changle West Road, Xi'an, 710032, Shanxi, China. 5. Beijing Huilongguan Hospital, Hui Long Guan, Changping District, Beijing, 100096, China. 6. Guangzhou Brain Hospital, No.36 Mingxin Road, Guangzhou, 510170, Guangdong, China. 7. Brain Hospital of Hunan Province, No.427 Furong Zhonglu 3 duan, Changsha, 410007, Hunan, China. 8. Tongji Hospital Affiliated to Tongji University, No.389 Xincun Road, Shanghai, 200065, China. 9. The 1st Affiliated Hospital of Kunming Medical College, No.295 Xichang Road, Kunming, 650032, Yunnan, China. 10. Xi'an Mental Health Center, No. 15 Yanyin Road Qujiang New District, Xi'an, 710061, Shanxi, China. 11. First Affiliated Hospital of Medical College of Xi'an Jiaotong University, No.277 Yanta West Road, Xi'an, 710061, Shanxi, China. 12. Central South University Xiangya No 2 Hospital, No.139 Middle Renmin Road, Changsha, 410008, Hunan, China. 13. 1st Affiliated Hospital of Shan Xi Medical University, No.85 Jiefang South Road, Taiyuan, 030001, Shanxi, China. 14. Tianjin Anding Hospital, No.13 Liulin Road, Hexi District, Tianjin, 300222, China. 15. Renmin Hospital of Wuhan University, No.238 Jiefang Road, Wuchang District, Wuhan, 430060, Hubei, China. 16. Hebei No.6 Hospital, No.572 Dongfeng East Road, Baoding, 071000, Hebei, China. 17. The 2nd Affiliated Hospital of Zhejiang University School of Medicine, No.88 Jie Fang Road, Hangzhou, 100027, Zhejiang, China. 18. The First Affiliated Hospital of Medical School of Zhejiang University, No.58 Chengzhan Road, Hangzhou, 310003, Zhejiang, China. 19. Nanjing Brain Hospital, No.264 Guangzhou Road, Nanjing, 210029, China. 20. Peking University Sixth Hospital, No.51 North Huayuan Rd., Haidian District, Beijing, 100191, China. yuxinsci@163.com.
Abstract
RATIONALE: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).
RCT Entities:
RATIONALE: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).
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