The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8-week, prospective, open-label, multicenter, single-arm study

Introduction This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients. Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive an...

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Veröffentlicht in:Asia-Pacific psychiatry 2016-09, Vol.8 (3), p.241-244
Hauptverfasser: Liang, Ying, Cao, Changan, Zhu, Cheng, Wang, Chuanyue, Zhang, Congpei, Dong, Fang, Yang, Fude, Deng, Hong, Yu, Jingjie, Tang, Jisheng, Su, Lei, Xin, Limin, Hong, Ling, Gao, Minglong, Tang, Muni, Xie, Shiping, Lu, Shuiping, Liu, Tiebang, Xu, Xiaojin, Wang, Xijin, Li, Xuanzi, Wang, Xueyi, Li, Yi, Zhang, Yong, Chen, Zhiyu, Yu, Xin
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container_end_page 244
container_issue 3
container_start_page 241
container_title Asia-Pacific psychiatry
container_volume 8
creator Liang, Ying
Cao, Changan
Zhu, Cheng
Wang, Chuanyue
Zhang, Congpei
Dong, Fang
Yang, Fude
Deng, Hong
Yu, Jingjie
Tang, Jisheng
Su, Lei
Xin, Limin
Hong, Ling
Gao, Minglong
Tang, Muni
Xie, Shiping
Lu, Shuiping
Liu, Tiebang
Xu, Xiaojin
Wang, Xijin
Li, Xuanzi
Wang, Xueyi
Li, Yi
Zhang, Yong
Chen, Zhiyu
Yu, Xin
description Introduction This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients. Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. Discussion Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia.
doi_str_mv 10.1111/appy.12238
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Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. 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Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. Discussion Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia.</abstract><cop>Australia</cop><pub>Blackwell Publishing Ltd</pub><pmid>27020720</pmid><doi>10.1111/appy.12238</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record>
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subjects Adolescent
Adult
Amisulpride
Antipsychotic Agents - therapeutic use
antipsychotic agents/adverse effects
Brief Report
Brief Reports
Chinese
Female
Humans
Male
Middle Aged
Patients
Prospective Studies
Schizophrenia
Schizophrenia - drug therapy
Sulpiride - analogs & derivatives
Sulpiride - therapeutic use
Treatment Outcome
Young Adult
title The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8-week, prospective, open-label, multicenter, single-arm study
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