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

The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8‐week,... amisulpride, antipsychotic agents/adverse Introduction: This study evaluated the effectiveness and safety of ami- effects, antipsychotic agents/therapeutic use, sulpride in Chinese schizophrenia patients. Chinese, Schizophrenia Methods: A multicenter, single-arm Phase IV study (NCT01795183). Correspondence Chinese patients with schizophrenia received amisulpride for 8 weeks. The Xin Yu, MD, National Clinical Research Center primary endpoint was ≥50% decrease in Positive and Negative Syndrome for Mental Disorders, Peking University Sixth Scale total score from Baseline to Week 8. Hospital, Institute of Mental Health, and the Key Results: A total of 316 patients were enrolled; 295 were included in the Laboratory of Mental Health, Ministry of Health, effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive Peking University, 51 Huayuanbei Road, Haidian and Negative Syndrome Scale total score from Baseline to Week 8. Nine District, Beijing 100191, China. patients discontinued treatment because of adverse events. Tel: +86-10-82801999 Discussion: Amisulpride had clinical effectiveness and was relatively well Fax: +86-10-62026310 tolerated in Chinese patients with schizophrenia. E-mail: yuxin078@163.com Received 7 August 2015 Accepted 3 February 2016 DOI:10.1111/appy.12238 patients are particularly scarce.(Hwang et al., 2003; Introduction Wang et al., 2008; Ahn et al., 2011; Lee et al., 2012) The majority of extant efficacy and safety data for Therapeutic responses to amisulpride have shown amisulpride (Solian®) come from studies conducted in significant inter-patient variability and will likely differ Western patients. In Asian populations, only a small between geographic regions because of factors such as number of relevant studies of amisulpride have been pharmacogenetics, and local standards of care and reported, and these included relatively small numbers dosing recommendations.(Brandl et al., 2014; Lally & of patients. Furthermore, the data available in Chinese MacCabe, 2015) Therefore, the present study was Asia-Pacific Psychiatry 8 (2016) 241–244 241 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. Amilsulpride in Chinese patients Y. Liang et al. designed in order to assess the effectiveness and safety of All statistical analyses and treatment effects were amisulpride in Chinese patients with schizophrenia. tested at a two-sided significance level of 0.05. Statistical Analytic System software version 9.2 (SAS Institute, Cary, North Carolina, USA) was used to perform all sta- Methods tistical analyses. Study design and patients Results This 8-week,prospective,multicenter,single-arm Phase IV study was conducted at 13 psychiatric-specialist Tier 1 In total, 316 patients were enrolled, and 251 completed hospitals in China between 30 October 2012 and 3 the 8-week study. Among patients in the effectiveness December 2013. Adults (18–65 years) who met the ICD- analysis, 66.8% (197/295) achieved the primary 10 criteria for schizophrenia, and had a Positive and Nega- endpoint (Table 1). An early clinical response (≥20% tive Syndrome Scale (PANSS) total score ≥60, were eligi- improvement in PANSS total score after 2 weeks of ble for inclusion. Enrollment included patients treated as treatment) was achieved by 56.6% of patients. inpatients and outpatients. The study was conducted in ac- A similar proportion of the treatment-naive and pre- cordance with the principles of the declaration of Helsinki viously treated patients achieved a ≥50% decrease in and received ethical approval from local institutional PANSS total score from Baseline to Week 8 (68.6% versus ethics review boards at all participating centers. Written in- 66.2%) (Table 1). Among the 266 patients with predomi- formed consent was obtained from all study subjects. The nantly positive symptoms, 68.4% achieved a ≥50% study was registered at ClinicalTrials.gov (NCT01795183). decrease in PANSS total score by Week 8. Of the 26 patients with predominantly negative symptoms, 50.0% Treatment achieved a ≥50% decrease in PANSS total score at Week 8. A total of nine (3.1%) patients withdrew from the After a screening phase, amisulpride tablets (50 mg/ study because of an adverse reaction, and one patient tablet) were administered orally for 8 weeks; dosing experienced a serious AE (suicide attempt), which the and titration were in accordance with the approved investigator judged was not related to the study Chinese labeling (http://drugs.medlive.cn/drugref/ treatment. The incidence of drug-related, treatment- html/15330.shtml. Accessed October 2015). In patients emergent AEs was 58.9% (186/316) (Table 1). switching from other antipsychotics (because of subopti- mal treatment response or unacceptable adverse events [AEs]), the dose of the previous medication was gradu- Discussion ally reduced upon initiation of amisulpride, with the aim of complete discontinuation within 1 week. The results of this single-arm study show that 8-week treatment with amisulpride effectively improved the clinical symptoms of Chinese patients with schizophre- Measurements nia; approximately two thirds (66.8%) of patients The primary effectiveness endpoint was a ≥50% decrease achieved a ≥50% decrease in PANSS total score from in PANSS total score from Baseline to Week 8. Two sub- Baseline to Week 8. In addition, a rapid response to group analyses were conducted: in treatment-naive pa- amisulpride treatment was observed in the majority of tients versus patients who were switched to amisulpride, patients; 56.6% of study subjects achieved a ≥20% and in patients with predominantly positive versus improvement in PANSS total score from Baseline to predominantly negative symptoms. Safety data were Week 2. Interestingly, results of a subgroup analysis continuously monitored from Baseline to the end of the suggested that amisulpride is equally effective for study. Blood samples for prolactin level testing were treatment-naive schizophrenia patients and those who taken from patients in the morning before breakfast. switch to amisulpride from other antipsychotics. Although a direct comparison of this study with previous research is difficult, because of variability in Statistics study duration, enrolment criteria, and assessment Using an estimate that 60% of patients would achieve a variables, the effectiveness results broadly support sev- ≥50% improvement in PANSS total score after 8 weeks, eral prior studies conducted in other countries.(Carriere enrolment of 300 patients would provide a 95% confi- et al., 2000; Sechter et al., 2002; Mortimer et al., 2004) dence interval of 53.64% to 66.12%, accounting for a The incidence of extrapyramidal side effects reported in 16% dropout rate.(Kuang et al., 2009) the present study (25.9%) is comparable with two 242 Asia-PacificPsychiatry 8(2016) 241–244 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd Y. Liang et al. Amilsulpride in Chinese patients Table 1. Summary of study results Variable Baseline characteristics Male, n (%) 148 (46.8) (SS; n =316) Mean age (years ± SD) 32.6 ± 11.8 Mean BMI (kg/cm ± SD) 23.1 ± 4.0 Type of schizophrenia defined by ICD-10, n (%) Paranoid 192 (60.8) Undifferentiated 101 (32.0) Other 17 (5.4) Unspecified 6 (1.9) Received previous treatment for schizophrenia, n (%) 237 (75.0) Treatment exposure (SS, n = 316) Mean starting dose of amisulpride, mg ± SD 243.7 ± 115.6 Mean daily dose of amisulpride over 8-week study duration, mg ± SD 678.0 ± 224.6 Use of any concomitant medication, n (%) 257 (81.3) Effectiveness (ITT, n = 295) Primary endpoint: ≥50% decrease in PANSS total score from 197 (66.8) [61.1–72.1] Baseline to Week 8, n (%) [95% CI] Treatment naive patients (n = 70) 48 (68.6) Pre-treated patients switching to amisulpride (n = 225) 149 (66.2) Predominantly positive symptoms (n = 266) 182 (68.4) Predominantly negative symptoms (n = 26) 13 (50.0) Early response: ≥20% decrease in PANSS total score from 167 (56.6) [50.7–62.3] Baseline to Week 2, n (%) [95% CI] Safety (n =316) ≥1AE, n (%) 187 (59.2) ≥1 treatment-related AE, n (%) 186 (58.9) Nervous system, n (%) 107 (33.9) Extrapyramidal side effects 82 (25.9) Akathisia 15 (4.7) Dystonia 8 (2.5) Laboratory testing and electrocardiogram, n (%) 93 (29.4) Blood prolactin increase (>25 ng/mL) 82 (25.9) Weight gain (>7% increase from Baseline) 14 (4.4) Endocrine system, n (%) 26 (8.2) Hyperprolactinemia 26 (8.2) AE, adverse event; BMI, body mass index; ICD-10, Tenth Revision of the International Classification of Diseases and Related Health Problems; ITT, Intention-to-Treat, the effectiveness analysis population defined as patients who received at least one dose of study medication and underwent at least one assessment of the primary effectiveness variable; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation; SS, safety analysis population, defined as all patients who received at least one dose of study medication. In 305 patients with available data. Last observation carried forward. Patients may have reported >1 adverse event. blood prolactin increase with clinical symptoms. [Corrections added on 16 May 2016, after first online publication: All occurrences of ‘%(n)’ and the format of its corresponding data have been amended to ‘n (%)’ throughout the above table for consistency.] previous reports (23% and 13%) (Carriere et al., 2000; assistance was provided by Jake Burrell of Adelphi Consultech and funded by Sanofi. The authors received Colonna et al., 2000). sponsorship (AMISU_L_06155) from Sanofi (China) to The primary limitation of this study was that pa- conduct this study and have no further conflicts of interest. tients with predominantly positive symptoms accounted for the majority of the patients included, which may limit the generalizability of the results. Contributorship statements All authors drafted or revised the work for intellectual Acknowledgments content and approved the final version. All authors agree to be accountable for all aspects of the work in Sanofi (China) provided funding for this study and devel- oped and approved the study protocol. No financial or other ensuring that questions related to the accuracy or integ- incentives were given to study participants. Editorial rity of any part of the work are appropriately Asia-Pacific Psychiatry 8 (2016) 241–244 243 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd Amilsulpride in Chinese patients Y. Liang et al. investigated and resolved. Ying Liang: Conception and References design of the work and the acquisition and interpreta- Ahn Y.M., Lee K.Y., Kim C.E., et al. (2011) The acute and tion of data, analysis of data. Changan Cao: Conception long-term effectiveness of amisulpride in patients with and design of the work and the acquisition and interpre- schizophrenia: results of a 12-month open-label pro- tation of data. Cheng Zhu: Conception and design of the spective follow-up study. Hum Psychopharmacol. 26, work and the acquisition and interpretation of data. 568–577. Chuanyue Wang: Conception and design of the work Brandl E.J., Kennedy J.L., Muller D.J. (2014) and the acquisition and interpretation of data. Congpei Pharmacogenetics of antipsychotics. Can J Psychiatry 59, Zhang: Conception and design of the work and the 76–88. acquisition and interpretation of data. Fang Dong: Carriere P., Bonhomme D., Lemperiere T. (2000) Conception and design of the work and the acquisition Amisulpride has a superior benefit/risk profile to and interpretation of data. Fude Yang: Conception and haloperidol in schizophrenia: results of a multicentre, design of the work and the acquisition and interpreta- double-blind study (the Amisulpride Study Group). Eur tion of data, Hong Deng: Conception and design of the Psychiatry 15, 321–329. work and the acquisition and interpretation of data. Colonna L., Saleem P., Dondey-Nouvel L., Rein W. (2000) Jingjie Yu: Conception and design of the work and the Long-term safety and efficacy of amisulpride in sub- acquisition and interpretation of data. Jisheng Tang: chronic or chronic schizophrenia. Amisulpride Study Conception and design of the work and the acquisition Group. Int Clin Psychopharmacol. 15, 13–22. and interpretation of data. Lei Su: Conception and Hwang T.J., Lee S.M., Sun H.J., et al. (2003). Amisulpride design of the work and the acquisition and interpreta- versus risperidone in the treatment of schizophrenic pa- tion of data. Limin Xin: Conception and design of the tients: a double-blind pilot study in Taiwan. J Formos work and the acquisition and interpretation of data. Ling Med Assoc. 102, 30–36. Hong: Conception and design of the work and the acqui- Kuang Y., Li X., Zhong X., Li X. (2009) A preliminary sition and interpretation of data. Minglong Gao: Concep- clinical study of amisulpride in treatment of forty patients tion and design of the work and the acquisition and with schizophrenia. J Psychiatry 22, 180–181. interpretation of data. Muni Tang: Conception and Lally J., MacCabe J.H. (2015) Antipsychotic medication in design of the work and the acquisition and interpreta- schizophrenia: a review. Br Med Bull. 114, 169–179. tion of data. Shiping Xie: Conception and design of the work and the acquisition and interpretation of data. Lee S.J., Lee J.H., Jung S.W., Koo B.H., Choi T.Y., Lee K.H. Shuiping Lu: Conception and design of the work and (2012) A 6-week, randomized, multicentre, open-label the acquisition and interpretation of data. Tiebang Liu: study comparing efficacy and tolerability of amisulpride Conception and design of the work and the acquisition at a starting dose of 400 mg/day versus 800 mg/day in patients with acute exacerbations of schizophrenia. Clin and interpretation of data. Xiaojin Xu: Conception and Drug Investig. 32, 735–745. design of the work and the acquisition and interpreta- tion of data. Xijin Wang: Conception and design of the Mortimer A., Martin S., Loo H., Peuskens J. (2004) A work and the acquisition and interpretation of data. double-blind, randomized comparative trial of Xuanzi Li: Conception and design of the work and the amisulpride versus olanzapine for 6 months in the acquisition and interpretation of data. Xueyi Wang: treatment of schizophrenia. Int Clin Psychopharmacol. 19, 63–69. Conception and design of the work and the acquisition and interpretation of data. Yi Li: Conception and design Sechter D., Peuskens J., Fleurot O., Rein W., Lecrubier Y. of the work and the acquisition and interpretation of (2002) Amisulpride vs. risperidone in chronic schizo- data. Yong Zhang: Conception and design of the work phrenia: results of a 6-month double-blind study. Neuropsychopharmacology 27, 1071–1081. and the acquisition and interpretation of data. Zhiyu Chen: Conception and design of the work and the acqui- Wang Y.T., Chiu N.Y., Jou S.H., et al. (2008) Effects of sition and interpretation of data. Xin Yu: Conception and amisulpride on the cognitive function of patients with design of the work and the acquisition and interpreta- schizophrenia who switched from risperidone. Int J Psy- tion of data, analysis of data. chiatry Clin Pract. 12, 180–186. 244 Asia-PacificPsychiatry 8(2016) 241–244 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Asia-Pacific Psychiatry Wiley

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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Wiley
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© 2016 John Wiley & Sons Australia, Ltd
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1758-5864
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10.1111/appy.12238
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Abstract

amisulpride, antipsychotic agents/adverse Introduction: This study evaluated the effectiveness and safety of ami- effects, antipsychotic agents/therapeutic use, sulpride in Chinese schizophrenia patients. Chinese, Schizophrenia Methods: A multicenter, single-arm Phase IV study (NCT01795183). Correspondence Chinese patients with schizophrenia received amisulpride for 8 weeks. The Xin Yu, MD, National Clinical Research Center primary endpoint was ≥50% decrease in Positive and Negative Syndrome for Mental Disorders, Peking University Sixth Scale total score from Baseline to Week 8. Hospital, Institute of Mental Health, and the Key Results: A total of 316 patients were enrolled; 295 were included in the Laboratory of Mental Health, Ministry of Health, effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive Peking University, 51 Huayuanbei Road, Haidian and Negative Syndrome Scale total score from Baseline to Week 8. Nine District, Beijing 100191, China. patients discontinued treatment because of adverse events. Tel: +86-10-82801999 Discussion: Amisulpride had clinical effectiveness and was relatively well Fax: +86-10-62026310 tolerated in Chinese patients with schizophrenia. E-mail: yuxin078@163.com Received 7 August 2015 Accepted 3 February 2016 DOI:10.1111/appy.12238 patients are particularly scarce.(Hwang et al., 2003; Introduction Wang et al., 2008; Ahn et al., 2011; Lee et al., 2012) The majority of extant efficacy and safety data for Therapeutic responses to amisulpride have shown amisulpride (Solian®) come from studies conducted in significant inter-patient variability and will likely differ Western patients. In Asian populations, only a small between geographic regions because of factors such as number of relevant studies of amisulpride have been pharmacogenetics, and local standards of care and reported, and these included relatively small numbers dosing recommendations.(Brandl et al., 2014; Lally & of patients. Furthermore, the data available in Chinese MacCabe, 2015) Therefore, the present study was Asia-Pacific Psychiatry 8 (2016) 241–244 241 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. Amilsulpride in Chinese patients Y. Liang et al. designed in order to assess the effectiveness and safety of All statistical analyses and treatment effects were amisulpride in Chinese patients with schizophrenia. tested at a two-sided significance level of 0.05. Statistical Analytic System software version 9.2 (SAS Institute, Cary, North Carolina, USA) was used to perform all sta- Methods tistical analyses. Study design and patients Results This 8-week,prospective,multicenter,single-arm Phase IV study was conducted at 13 psychiatric-specialist Tier 1 In total, 316 patients were enrolled, and 251 completed hospitals in China between 30 October 2012 and 3 the 8-week study. Among patients in the effectiveness December 2013. Adults (18–65 years) who met the ICD- analysis, 66.8% (197/295) achieved the primary 10 criteria for schizophrenia, and had a Positive and Nega- endpoint (Table 1). An early clinical response (≥20% tive Syndrome Scale (PANSS) total score ≥60, were eligi- improvement in PANSS total score after 2 weeks of ble for inclusion. Enrollment included patients treated as treatment) was achieved by 56.6% of patients. inpatients and outpatients. The study was conducted in ac- A similar proportion of the treatment-naive and pre- cordance with the principles of the declaration of Helsinki viously treated patients achieved a ≥50% decrease in and received ethical approval from local institutional PANSS total score from Baseline to Week 8 (68.6% versus ethics review boards at all participating centers. Written in- 66.2%) (Table 1). Among the 266 patients with predomi- formed consent was obtained from all study subjects. The nantly positive symptoms, 68.4% achieved a ≥50% study was registered at ClinicalTrials.gov (NCT01795183). decrease in PANSS total score by Week 8. Of the 26 patients with predominantly negative symptoms, 50.0% Treatment achieved a ≥50% decrease in PANSS total score at Week 8. A total of nine (3.1%) patients withdrew from the After a screening phase, amisulpride tablets (50 mg/ study because of an adverse reaction, and one patient tablet) were administered orally for 8 weeks; dosing experienced a serious AE (suicide attempt), which the and titration were in accordance with the approved investigator judged was not related to the study Chinese labeling (http://drugs.medlive.cn/drugref/ treatment. The incidence of drug-related, treatment- html/15330.shtml. Accessed October 2015). In patients emergent AEs was 58.9% (186/316) (Table 1). switching from other antipsychotics (because of subopti- mal treatment response or unacceptable adverse events [AEs]), the dose of the previous medication was gradu- Discussion ally reduced upon initiation of amisulpride, with the aim of complete discontinuation within 1 week. The results of this single-arm study show that 8-week treatment with amisulpride effectively improved the clinical symptoms of Chinese patients with schizophre- Measurements nia; approximately two thirds (66.8%) of patients The primary effectiveness endpoint was a ≥50% decrease achieved a ≥50% decrease in PANSS total score from in PANSS total score from Baseline to Week 8. Two sub- Baseline to Week 8. In addition, a rapid response to group analyses were conducted: in treatment-naive pa- amisulpride treatment was observed in the majority of tients versus patients who were switched to amisulpride, patients; 56.6% of study subjects achieved a ≥20% and in patients with predominantly positive versus improvement in PANSS total score from Baseline to predominantly negative symptoms. Safety data were Week 2. Interestingly, results of a subgroup analysis continuously monitored from Baseline to the end of the suggested that amisulpride is equally effective for study. Blood samples for prolactin level testing were treatment-naive schizophrenia patients and those who taken from patients in the morning before breakfast. switch to amisulpride from other antipsychotics. Although a direct comparison of this study with previous research is difficult, because of variability in Statistics study duration, enrolment criteria, and assessment Using an estimate that 60% of patients would achieve a variables, the effectiveness results broadly support sev- ≥50% improvement in PANSS total score after 8 weeks, eral prior studies conducted in other countries.(Carriere enrolment of 300 patients would provide a 95% confi- et al., 2000; Sechter et al., 2002; Mortimer et al., 2004) dence interval of 53.64% to 66.12%, accounting for a The incidence of extrapyramidal side effects reported in 16% dropout rate.(Kuang et al., 2009) the present study (25.9%) is comparable with two 242 Asia-PacificPsychiatry 8(2016) 241–244 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd Y. Liang et al. Amilsulpride in Chinese patients Table 1. Summary of study results Variable Baseline characteristics Male, n (%) 148 (46.8) (SS; n =316) Mean age (years ± SD) 32.6 ± 11.8 Mean BMI (kg/cm ± SD) 23.1 ± 4.0 Type of schizophrenia defined by ICD-10, n (%) Paranoid 192 (60.8) Undifferentiated 101 (32.0) Other 17 (5.4) Unspecified 6 (1.9) Received previous treatment for schizophrenia, n (%) 237 (75.0) Treatment exposure (SS, n = 316) Mean starting dose of amisulpride, mg ± SD 243.7 ± 115.6 Mean daily dose of amisulpride over 8-week study duration, mg ± SD 678.0 ± 224.6 Use of any concomitant medication, n (%) 257 (81.3) Effectiveness (ITT, n = 295) Primary endpoint: ≥50% decrease in PANSS total score from 197 (66.8) [61.1–72.1] Baseline to Week 8, n (%) [95% CI] Treatment naive patients (n = 70) 48 (68.6) Pre-treated patients switching to amisulpride (n = 225) 149 (66.2) Predominantly positive symptoms (n = 266) 182 (68.4) Predominantly negative symptoms (n = 26) 13 (50.0) Early response: ≥20% decrease in PANSS total score from 167 (56.6) [50.7–62.3] Baseline to Week 2, n (%) [95% CI] Safety (n =316) ≥1AE, n (%) 187 (59.2) ≥1 treatment-related AE, n (%) 186 (58.9) Nervous system, n (%) 107 (33.9) Extrapyramidal side effects 82 (25.9) Akathisia 15 (4.7) Dystonia 8 (2.5) Laboratory testing and electrocardiogram, n (%) 93 (29.4) Blood prolactin increase (>25 ng/mL) 82 (25.9) Weight gain (>7% increase from Baseline) 14 (4.4) Endocrine system, n (%) 26 (8.2) Hyperprolactinemia 26 (8.2) AE, adverse event; BMI, body mass index; ICD-10, Tenth Revision of the International Classification of Diseases and Related Health Problems; ITT, Intention-to-Treat, the effectiveness analysis population defined as patients who received at least one dose of study medication and underwent at least one assessment of the primary effectiveness variable; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation; SS, safety analysis population, defined as all patients who received at least one dose of study medication. In 305 patients with available data. Last observation carried forward. Patients may have reported >1 adverse event. blood prolactin increase with clinical symptoms. [Corrections added on 16 May 2016, after first online publication: All occurrences of ‘%(n)’ and the format of its corresponding data have been amended to ‘n (%)’ throughout the above table for consistency.] previous reports (23% and 13%) (Carriere et al., 2000; assistance was provided by Jake Burrell of Adelphi Consultech and funded by Sanofi. The authors received Colonna et al., 2000). sponsorship (AMISU_L_06155) from Sanofi (China) to The primary limitation of this study was that pa- conduct this study and have no further conflicts of interest. tients with predominantly positive symptoms accounted for the majority of the patients included, which may limit the generalizability of the results. Contributorship statements All authors drafted or revised the work for intellectual Acknowledgments content and approved the final version. All authors agree to be accountable for all aspects of the work in Sanofi (China) provided funding for this study and devel- oped and approved the study protocol. No financial or other ensuring that questions related to the accuracy or integ- incentives were given to study participants. Editorial rity of any part of the work are appropriately Asia-Pacific Psychiatry 8 (2016) 241–244 243 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd Amilsulpride in Chinese patients Y. Liang et al. investigated and resolved. Ying Liang: Conception and References design of the work and the acquisition and interpreta- Ahn Y.M., Lee K.Y., Kim C.E., et al. (2011) The acute and tion of data, analysis of data. Changan Cao: Conception long-term effectiveness of amisulpride in patients with and design of the work and the acquisition and interpre- schizophrenia: results of a 12-month open-label pro- tation of data. Cheng Zhu: Conception and design of the spective follow-up study. Hum Psychopharmacol. 26, work and the acquisition and interpretation of data. 568–577. Chuanyue Wang: Conception and design of the work Brandl E.J., Kennedy J.L., Muller D.J. (2014) and the acquisition and interpretation of data. Congpei Pharmacogenetics of antipsychotics. Can J Psychiatry 59, Zhang: Conception and design of the work and the 76–88. acquisition and interpretation of data. Fang Dong: Carriere P., Bonhomme D., Lemperiere T. (2000) Conception and design of the work and the acquisition Amisulpride has a superior benefit/risk profile to and interpretation of data. Fude Yang: Conception and haloperidol in schizophrenia: results of a multicentre, design of the work and the acquisition and interpreta- double-blind study (the Amisulpride Study Group). Eur tion of data, Hong Deng: Conception and design of the Psychiatry 15, 321–329. work and the acquisition and interpretation of data. Colonna L., Saleem P., Dondey-Nouvel L., Rein W. (2000) Jingjie Yu: Conception and design of the work and the Long-term safety and efficacy of amisulpride in sub- acquisition and interpretation of data. Jisheng Tang: chronic or chronic schizophrenia. Amisulpride Study Conception and design of the work and the acquisition Group. Int Clin Psychopharmacol. 15, 13–22. and interpretation of data. Lei Su: Conception and Hwang T.J., Lee S.M., Sun H.J., et al. (2003). Amisulpride design of the work and the acquisition and interpreta- versus risperidone in the treatment of schizophrenic pa- tion of data. Limin Xin: Conception and design of the tients: a double-blind pilot study in Taiwan. J Formos work and the acquisition and interpretation of data. Ling Med Assoc. 102, 30–36. Hong: Conception and design of the work and the acqui- Kuang Y., Li X., Zhong X., Li X. (2009) A preliminary sition and interpretation of data. Minglong Gao: Concep- clinical study of amisulpride in treatment of forty patients tion and design of the work and the acquisition and with schizophrenia. J Psychiatry 22, 180–181. interpretation of data. Muni Tang: Conception and Lally J., MacCabe J.H. (2015) Antipsychotic medication in design of the work and the acquisition and interpreta- schizophrenia: a review. Br Med Bull. 114, 169–179. tion of data. Shiping Xie: Conception and design of the work and the acquisition and interpretation of data. Lee S.J., Lee J.H., Jung S.W., Koo B.H., Choi T.Y., Lee K.H. Shuiping Lu: Conception and design of the work and (2012) A 6-week, randomized, multicentre, open-label the acquisition and interpretation of data. Tiebang Liu: study comparing efficacy and tolerability of amisulpride Conception and design of the work and the acquisition at a starting dose of 400 mg/day versus 800 mg/day in patients with acute exacerbations of schizophrenia. Clin and interpretation of data. Xiaojin Xu: Conception and Drug Investig. 32, 735–745. design of the work and the acquisition and interpreta- tion of data. Xijin Wang: Conception and design of the Mortimer A., Martin S., Loo H., Peuskens J. (2004) A work and the acquisition and interpretation of data. double-blind, randomized comparative trial of Xuanzi Li: Conception and design of the work and the amisulpride versus olanzapine for 6 months in the acquisition and interpretation of data. Xueyi Wang: treatment of schizophrenia. Int Clin Psychopharmacol. 19, 63–69. Conception and design of the work and the acquisition and interpretation of data. Yi Li: Conception and design Sechter D., Peuskens J., Fleurot O., Rein W., Lecrubier Y. of the work and the acquisition and interpretation of (2002) Amisulpride vs. risperidone in chronic schizo- data. Yong Zhang: Conception and design of the work phrenia: results of a 6-month double-blind study. Neuropsychopharmacology 27, 1071–1081. and the acquisition and interpretation of data. Zhiyu Chen: Conception and design of the work and the acqui- Wang Y.T., Chiu N.Y., Jou S.H., et al. (2008) Effects of sition and interpretation of data. Xin Yu: Conception and amisulpride on the cognitive function of patients with design of the work and the acquisition and interpreta- schizophrenia who switched from risperidone. Int J Psy- tion of data, analysis of data. chiatry Clin Pract. 12, 180–186. 244 Asia-PacificPsychiatry 8(2016) 241–244 © 2016 The Authors Asia-Pacific Psychiatry Published by John Wiley & Sons Australia, Ltd

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