Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
10.13699/j.cnki.1001-6821.2024.05.005
- VernacularTitle:布瑞哌唑片治疗成人急性期精神分裂症患者的临床研究
- Author:
Shu-Zhe ZHOU
1
;
Liang LI
;
Dong YANG
;
Jin-Guo ZHAI
;
Tao JIANG
;
Yu-Zhong SHI
;
Bin WU
;
Xiang-Ping WU
;
Ke-Qing LI
;
Tie-Bang LIU
;
Jie LI
;
Shi-You TANG
;
Li-Li WANG
;
Xue-Yi WANG
;
Yun-Long TAN
;
Qi LIU
;
Uki MOTOMICHI
;
Ming-Ji XIAN
;
Hong-Yan ZHANG
Author Information
1. 北京大学第六医院,北京大学精神卫生研究所,国家卫生健康委员会精神卫生学重点实验室(北京大学),国家精神心理疾病临床医学研究中心(北京大学第六医院)国家药物临床试验机构办公室,北京 100191
- Keywords:
brexpiprazole;
aripiprazole;
schizophrenia;
efficacy;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(5):654-658
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50％(140 cases/184 cases)and 82.40％(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P＞0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P＞0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P＞0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00％vs.64.50％,P＞0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
