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Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial.
Psychopharmacology (Berl). 2016 Apr; 233(7):1289-97.P

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).

Authors+Show Affiliations

Shanghai Mental Health Center, No.600 South Wanping Road, Xuhui District, Shanghai, 200030, China.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.Beijing An Ding Hospital, Capital Medical University, No.5 An Kang Hutong Deshengmen wai, Xicheng District, Beijing, 100008, China.Xijing Hospital, No.127 Changle West Road, Xi'an, 710032, Shanxi, China.Beijing Huilongguan Hospital, Hui Long Guan, Changping District, Beijing, 100096, China.Guangzhou Brain Hospital, No.36 Mingxin Road, Guangzhou, 510170, Guangdong, China.Brain Hospital of Hunan Province, No.427 Furong Zhonglu 3 duan, Changsha, 410007, Hunan, China.Tongji Hospital Affiliated to Tongji University, No.389 Xincun Road, Shanghai, 200065, China.The 1st Affiliated Hospital of Kunming Medical College, No.295 Xichang Road, Kunming, 650032, Yunnan, China.Xi'an Mental Health Center, No. 15 Yanyin Road Qujiang New District, Xi'an, 710061, Shanxi, China.First Affiliated Hospital of Medical College of Xi'an Jiaotong University, No.277 Yanta West Road, Xi'an, 710061, Shanxi, China.Central South University Xiangya No 2 Hospital, No.139 Middle Renmin Road, Changsha, 410008, Hunan, China.1st Affiliated Hospital of Shan Xi Medical University, No.85 Jiefang South Road, Taiyuan, 030001, Shanxi, China.Tianjin Anding Hospital, No.13 Liulin Road, Hexi District, Tianjin, 300222, China.Renmin Hospital of Wuhan University, No.238 Jiefang Road, Wuchang District, Wuhan, 430060, Hubei, China.Hebei No.6 Hospital, No.572 Dongfeng East Road, Baoding, 071000, Hebei, China.The 2nd Affiliated Hospital of Zhejiang University School of Medicine, No.88 Jie Fang Road, Hangzhou, 100027, Zhejiang, China.The First Affiliated Hospital of Medical School of Zhejiang University, No.58 Chengzhan Road, Hangzhou, 310003, Zhejiang, China.Nanjing Brain Hospital, No.264 Guangzhou Road, Nanjing, 210029, China.Peking University Sixth Hospital, No.51 North Huayuan Rd., Haidian District, Beijing, 100191, China. yuxinsci@163.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26911380

Citation

Li, Huafang, et al. "Efficacy and Safety of Quetiapine Extended Release Monotherapy in Bipolar Depression: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial." Psychopharmacology, vol. 233, no. 7, 2016, pp. 1289-97.
Li H, Gu N, Zhang H, et al. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2016;233(7):1289-97.
Li, H., Gu, N., Zhang, H., Wang, G., Tan, Q., Yang, F., Ning, Y., Zhang, H., Lu, Z., Xu, X., Shi, J., Gao, C., Li, L., Zhang, K., Tian, H., Wang, X., Li, K., Li, H., Xu, Y., ... Yu, X. (2016). Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology, 233(7), 1289-97. https://doi.org/10.1007/s00213-016-4215-z
Li H, et al. Efficacy and Safety of Quetiapine Extended Release Monotherapy in Bipolar Depression: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial. Psychopharmacology (Berl). 2016;233(7):1289-97. PubMed PMID: 26911380.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. AU - Li,Huafang, AU - Gu,Niufan, AU - Zhang,Hongyan, AU - Wang,Gang, AU - Tan,Qingrong, AU - Yang,Fude, AU - Ning,Yuping, AU - Zhang,Honggeng, AU - Lu,Zheng, AU - Xu,Xiufeng, AU - Shi,Jianguo, AU - Gao,Chengge, AU - Li,Lingjiang, AU - Zhang,Kerang, AU - Tian,Hongjun, AU - Wang,Xiaoping, AU - Li,Keqing, AU - Li,Huichun, AU - Xu,Yi, AU - Xie,Shiping, AU - Yu,Xin, Y1 - 2016/02/25/ PY - 2015/06/07/received PY - 2016/01/12/accepted PY - 2016/2/26/entrez PY - 2016/2/26/pubmed PY - 2016/12/15/medline KW - Adverse events KW - Bipolar depression KW - MADRS KW - Quetiapine XR SP - 1289 EP - 97 JF - Psychopharmacology JO - Psychopharmacology (Berl.) VL - 233 IS - 7 N2 - 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). SN - 1432-2072 UR - https://www.unboundmedicine.com/medline/citation/26911380/Efficacy_and_safety_of_quetiapine_extended_release_monotherapy_in_bipolar_depression:_a_multi_center_randomized_double_blind_placebo_controlled_trial_ L2 - https://dx.doi.org/10.1007/s00213-016-4215-z DB - PRIME DP - Unbound Medicine ER -