机构：[1]Institute of Mental Health, The Sixth Hospital of Peking University, China[2]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China[3]Institute of Mental Health, The Sixth Hospital of Peking University, China[4]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China,and Department of Psychiatry, Jining Medical University, China[5]Psychiatry Research Center, Beijing HuiLongGuan Hospital, Peking University, China四川大学华西医院[6]Department of Psychiatry, First Hospital/First Clinical Medical College of Shanxi Medical University, China[7]Mental Health Center, West China Hospital, Sichuan University, China四川大学华西医院[8]Shanghai Mental Health Center, Shanghai Jiaotong University, China[9]Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, China[10]Hebei Mental Health Center, The Sixth People’s Hospital of Hebei Province, China[11]Wuxi Mental Health Center, Nanjing Medical University, China浙江大学医学院附属第一医院[12]Department of Geriatric Psychiatry, Nanjing Brain Hospital Affiliated to Nanjing Medical University, China广东省人民医院[13]Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, China浙江大学医学院附属第一医院[14]The Key Laboratory of Mental Disorder’s Management of Zhejiang Province, China[15]Guangdong Mental Health Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong province, China神经科系统神经内科广东省人民医院首都医科大学宣武医院[16]School of Medicine, South China University of Technology, Guangzhou, Guangdong province, China[17]Department of Psychiatry, Mental Health Center of Sichuan Province, China广东省人民医院[18]Department of Psychiatry, Jining Mental Hospital, China[19]Department of Neurology, Xuanwu Hospital, Capital Medical University, China神经科系统神经内科首都医科大学宣武医院[20]Department of Radiology, China-Japan Friendship Hospital Affiliated to the Ministry of Health of PRC, China[21]Institute of Mental Health, The Sixth Hospital of Peking University, China,and Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China[22]Institute of Mental Health, The Sixth Hospital of Peking University, China[23]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China[24]Institute of Mental Health, The Sixth Hospital of Peking University, China[25]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China[26]Institute of Mental Health, The Sixth Hospital of Peking University, China[27]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China[28]Guangdong Mental Health Center, Guangdong General Hospital, China广东省人民医院[29]School of Medicine, South China University of Technology, Guangzhou, Guangdong province, China[30]Hebei Mental Health Center, The Sixth People’s Hospital of Hebei Province, China[31]Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, China[32]Department of Neurology, Xuanwu Hospital, Capital Medical University, China神经科系统神经内科首都医科大学宣武医院[33]Shanghai Mental Health Center, Shanghai Jiaotong University, China[34]Mental Health Center, West China Hospital, Sichuan University, China四川大学华西医院[35]HuiLongGuan Clinical Medical School, Beijing HuiLongGuan Hospital, Peking University, China[36]Department of Psychiatry, First Hospital/First Clinical Medical College of Shanxi Medical University, China[37]Institute of Mental Health, The Sixth Hospital of Peking University, China[38]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China[39]Peking-Tsinghua Joint Center for Life Sciences, IDG/McGovern Institute for Brain Research, Peking University, China[40]Institute of Mental Health, The Sixth Hospital of Peking University, China[41]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China
Schizophrenia is a severe and complex psychiatric disorder that needs treatment based on extensive experience. Antipsychotic drugs have already become the cornerstone of the treatment for schizophrenia; however, the therapeutic effect is of significant variability among patients, and only around a third of patients with schizophrenia show good efficacy. Meanwhile, drug-induced metabolic syndrome and other side-effects significantly affect treatment adherence and prognosis. Therefore, strategies for drug selection are desperately needed. In this study, we will perform pharmacogenomics research and set up an individualised preferred treatment prediction model.We aim to create a standard clinical cohort, with multidimensional index assessment of antipsychotic treatment for patients with schizophrenia.This trial is designed as a randomised clinical trial comparing treatment with different kinds of antipsychotics. A total sample of 2000 patients with schizophrenia will be recruited from in-patient units from five clinical research centres. Using a computer-generated program, the participants will be randomly assigned to four treatment groups: aripiprazole, olanzapine, quetiapine and risperidone. The primary outcomes will be measured as changes in the Positive and Negative Syndrome Scale of schizophrenia, which reflects the efficacy. Secondary outcomes include the measure of side-effects, such as metabolic syndromes. The efficacy evaluation and side-effects assessment will be performed at baseline, 2 weeks, 6 weeks and 3 months.This trial will assess the efficacy and side effects of antipsychotics and create a standard clinical cohort with a multi-dimensional index assessment of antipsychotic treatment for schizophrenia patients.This study aims to set up an individualized preferred treatment prediction model through the genetic analysis of patients using different kinds of antipsychotics.
基金：
This work is supported by a grant to Weihua Yue on behalf of the whole projectfrom the Chinese
Ministry of Science and Technology (grant number 2016YFC1307000).
第一作者机构：[1]Institute of Mental Health, The Sixth Hospital of Peking University, China[2]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China
通讯作者：
通讯机构：[40]Institute of Mental Health, The Sixth Hospital of Peking University, China[41]Key Laboratory of Mental Health, Ministry of Health & National Clinical Research Center for Mental Disorders (Peking University), China
推荐引用方式(GB/T 7714)：
Yi Su,Hao Yu,Zhiren Wang,et al.Protocol for a pharmacogenomic study on individualised antipsychotic drug treatment for patients with schizophrenia.[J].BJPSYCH OPEN.2021,7(4):doi:10.1192/bjo.2021.945.
APA：
Yi Su,Hao Yu,Zhiren Wang,Sha Liu,Liansheng Zhao...&Weihua Yue.(2021).Protocol for a pharmacogenomic study on individualised antipsychotic drug treatment for patients with schizophrenia..BJPSYCH OPEN,7,(4)
MLA：
Yi Su,et al."Protocol for a pharmacogenomic study on individualised antipsychotic drug treatment for patients with schizophrenia.".BJPSYCH OPEN 7..4(2021)
