Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine‑resistant treatment‑refractory schizophrenia:a 12‑week randomized,double‑blind,placebo‑controlled trial  

作　　者：Ming‑Huan Zhu Zhen‑Jing Liu Qiong‑Yue Hu Jia‑Yu Yang Ying Jin Na Zhu Ying Huang Dian‑Hong Shi Min‑Jia Liu Hong‑Yang Tan Lei Zhao Qin‑Yu Lv Zheng‑Hui Yi Feng‑Chun Wu Ze‑Zhi Li 

机构地区：[1]Clinical Research Center for Mental Disorders,School of Medicine,Shanghai Pudong New Area Mental Health Center,Tongji University,Shanghai 200124,China [2]Qingdao Mental Health Center,Qingdao 266034,Shandong,China [3]Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200030,China [4]Department of Psychiatry,the Affiliated Brain Hospital of Guangzhou Medical University,Guangzhou 510370,China [5]Guangdong Engineering Technology Research Center for Translational Medicine of Mental Disorders,Guangzhou 510370,China

出　　处：《Military Medical Research》2023年第4期431-443,共13页军事医学研究（英文版）

基　　金：supported by the National Natural Science Foundation of China(81401127);the Clinical Research Project of Shanghai Municipal Health Commission(20204Y0173);the Open Project Program of State Key Laboratory of Virtual Reality Technology and Systems,Beihang University(VRLAB2022 B02);the Shanghai Key Laboratory of Psychotic Disorders Open Grant(21-K03);the Scientific Research Project of Traditional Chinese Medicine of Guangdong(20192070);the Guangzhou Municipal Key Discipline in Medicine(2021–2023);the Science and Technology Plan Project of Guangdong Province(2019B030316001).

摘　　要：Background:Although clozapine is an effective option for treatment-resistant schizophrenia(TRS),there are still 1/3 to 1/2 of TRS patients who do not respond to clozapine.The main purpose of this randomized,double-blind,placebocontrolled trial was to explore the amisulpride augmentation efficacy on the psychopathological symptoms and cognitive function of clozapine-resistant treatment-refractory schizophrenia(CTRS)patients.Methods:A total of 80 patients were recruited and randomly assigned to receive initial clozapine plus amisulpride(amisulpride group)or clozapine plus placebo(placebo group).Positive and Negative Syndrome Scale(PANSS),Scale for the Assessment of Negative Symptoms(SANS),Clinical Global Impression(CGI)scale scores,Repeatable Battery for the Assessment of Neuropsychological Status(RBANS),Treatment Emergent Symptom Scale(TESS),laboratory measurements,and electrocardiograms(ECG)were performed at baseline,week 6,and week 12.Results:Compared with the placebo group,amisulpride group had a lower PANSS total score,positive subscore,and general psychopathology subscore at week 6 and week 12(PBonferroni<0.01).Furthermore,compared with the placebo group,the amisulpride group showed an improved RBANS language score at week 12(PBonferroni<0.001).Amisulpride group had a higher treatment response rate(P=0.04),lower scores of CGI severity and CGI efficacy at week 6 and week 12 than placebo group(PBonferroni<0.05).There were no differences between the groups in body mass index(BMI),corrected QT(QTc)intervals,and laboratory measurements.This study demonstrates that amisulpride augmentation therapy can safely improve the psychiatric symptoms and cognitive performance of CTRS patients.

关 键 词：Schizophrenia Clozapine-resistant treatment-refractory schizophrenia CLOZAPINE AMISULPRIDE Augmentation 

分 类 号：R749.3[医药卫生—神经病学与精神病学]