title: Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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).
authors.affiliation: Shanghai Mental Health Center, No.600 South Wanping Road, Xuhui District, Shanghai, 200030, China.
authors.forename: Huafang
authors.initials: H
authors.lastname: Li
authors.affiliation: Shanghai Mental Health Center, No.600 South Wanping Road, Xuhui District, Shanghai, 200030, China.
authors.forename: Niufan
authors.initials: N
authors.lastname: Gu
authors.affiliation: Peking University Sixth Hospital, No.51 North Huayuan Rd., Haidian District, Beijing, 100191, China.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Beijing An Ding Hospital, Capital Medical University, No.5 An Kang Hutong Deshengmen wai, Xicheng District, Beijing, 100008, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Xijing Hospital, No.127 Changle West Road, Xi'an, 710032, Shanxi, China.
authors.forename: Qingrong
authors.initials: Q
authors.lastname: Tan
authors.affiliation: Beijing Huilongguan Hospital, Hui Long Guan, Changping District, Beijing, 100096, China.
authors.forename: Fude
authors.initials: F
authors.lastname: Yang
authors.affiliation: Guangzhou Brain Hospital, No.36 Mingxin Road, Guangzhou, 510170, Guangdong, China.
authors.forename: Yuping
authors.initials: Y
authors.lastname: Ning
authors.affiliation: Brain Hospital of Hunan Province, No.427 Furong Zhonglu 3 duan, Changsha, 410007, Hunan, China.
authors.forename: Honggeng
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Tongji Hospital Affiliated to Tongji University, No.389 Xincun Road, Shanghai, 200065, China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Lu
authors.affiliation: The 1st Affiliated Hospital of Kunming Medical College, No.295 Xichang Road, Kunming, 650032, Yunnan, China.
authors.forename: Xiufeng
authors.initials: X
authors.lastname: Xu
authors.affiliation: Xi'an Mental Health Center, No. 15 Yanyin Road Qujiang New District, Xi'an, 710061, Shanxi, China.
authors.forename: Jianguo
authors.initials: J
authors.lastname: Shi
authors.affiliation: First Affiliated Hospital of Medical College of Xi'an Jiaotong University, No.277 Yanta West Road, Xi'an, 710061, Shanxi, China.
authors.forename: Chengge
authors.initials: C
authors.lastname: Gao
authors.affiliation: Central South University Xiangya No 2 Hospital, No.139 Middle Renmin Road, Changsha, 410008, Hunan, China.
authors.forename: Lingjiang
authors.initials: L
authors.lastname: Li
authors.affiliation: 1st Affiliated Hospital of Shan Xi Medical University, No.85 Jiefang South Road, Taiyuan, 030001, Shanxi, China.
authors.forename: Kerang
authors.initials: K
authors.lastname: Zhang
authors.affiliation: Tianjin Anding Hospital, No.13 Liulin Road, Hexi District, Tianjin, 300222, China.
authors.forename: Hongjun
authors.initials: H
authors.lastname: Tian
authors.affiliation: Renmin Hospital of Wuhan University, No.238 Jiefang Road, Wuchang District, Wuhan, 430060, Hubei, China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Wang
authors.affiliation: Hebei No.6 Hospital, No.572 Dongfeng East Road, Baoding, 071000, Hebei, China.
authors.forename: Keqing
authors.initials: K
authors.lastname: Li
authors.affiliation: The 2nd Affiliated Hospital of Zhejiang University School of Medicine, No.88 Jie Fang Road, Hangzhou, 100027, Zhejiang, China.
authors.forename: Huichun
authors.initials: H
authors.lastname: Li
authors.affiliation: The First Affiliated Hospital of Medical School of Zhejiang University, No.58 Chengzhan Road, Hangzhou, 310003, Zhejiang, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Nanjing Brain Hospital, No.264 Guangzhou Road, Nanjing, 210029, China.
authors.forename: Shiping
authors.initials: S
authors.lastname: Xie
authors.affiliation: Peking University Sixth Hospital, No.51 North Huayuan Rd., Haidian District, Beijing, 100191, China. yuxinsci@163.com.
authors.forename: Xin
authors.initials: X
authors.lastname: Yu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D001714:Bipolar Disorder / Q000188:drug therapy*; D002681:China; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000069348:Quetiapine Fumarate
keywords: Adverse events; Bipolar depression; MADRS; Quetiapine XR