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

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

doi:10.1186/s40779-022-00420-0

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

RESEARCH | Updated：2023-09-05

- Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine-resistant treatment-refractory schizophrenia: a 12-week randomized, double-blind, placebo-controlled trial
- Military Medical Research Vol. 10, Issue 4, Pages: 431-443(2023)
- Affiliations：
  
  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
- Author bio：
  
  * 13580380071@163.com;
  biolpsychiatry@126.com
- Funds：
- DOI：10.1186/s40779-022-00420-0
  CLC：
- Published：2023-08
- Accepted：
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Zhu MH, Liu ZJ, Hu QY, Yang JY, Jin Y, Zhu N, et al. Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine-resistant treatment-refractory schizophrenia: a 12-week randomized, double-blind, placebo-controlled trial. Mil Med Res. 2022;9(1):59.
DOI：

Zhu MH, Liu ZJ, Hu QY, Yang JY, Jin Y, Zhu N, et al. Amisulpride augmentation therapy improves cognitive performance and psychopathology in clozapine-resistant treatment-refractory schizophrenia: a 12-week randomized, double-blind, placebo-controlled trial. Mil Med Res. 2022;9(1):59. DOI： 10.1186/s40779-022-00420-0.

摘要

Abstract

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 (

Bonferroni

0.01). Furthermore

compared with the placebo group

the amisulpride group showed an improved RBANS language score at week 12 (

Bonferroni

0.001). Amisulpride group had a higher treatment response rate (

=0.04)

lower scores of CGI severity and CGI efficacy at week 6 and week 12 than placebo group (

Bonferroni

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.

Conclusions:

This study indicates that amisulpride augmentation therapy has important clinical significance for treating CTRS to improve clinical symptoms and cognitive function with tolerability and safety.

Trial registration:

Clinicaltrials.gov identifier- NCT03652974. Registered August 31

2018

https://clinicaltrials.gov/ct2/show/NCT03652974

关键词

Keywords

references

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