| Title | Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia |
| Authors | Feng, Yuan Shi, Jianguo Wang, Lili Zhang, Xia Tan, Yunlong Zhao, Jingyuan Ning, Yuping Xie, Shiping Liu, Xuejun Liu, Qi Li, Keqing Wang, Xiaoliang Li, Lehua Xu, Xiufeng Deng, Wei Luo, Xiaoyan Wang, Gang |
| Affiliation | Capital Med Univ, Beijing Anding Hosp, Dept Psychiat, Natl Clin Res Ctr Mental Disorders, Beijing, Peoples R China Xian Mental Hlth Ctr, Dept Psychiat, Xian, Shaanxi, Peoples R China Tianjin Anding Hosp, Dept Psychiat, Tianjin, Peoples R China Wuxi Mental Hlth Ctr, Dept Psychiat, Wuxi, Jiangsu, Peoples R China Beijing Huilongguan Hosp, Dept Psychiat, Beijing, Peoples R China Henan Prov Mental Hosp, Dept Psychiat, Xinxiang, Henan, Peoples R China Guangzhou Brain Hosp, Dept Psychiat, Guangzhou, Guangdong, Peoples R China Nanjing Brain Hosp, Dept Psychiat, Nanjing, Jiangsu, Peoples R China Brain Hosp Hunan Prov, Dept Psychiat, Changsha, Hunan, Peoples R China Peking Univ, Hosp 6, Dept Psychiat, Beijing, Peoples R China Hebei Mental Hlth Ctr, Dept Psychiat, Baoding, Peoples R China Shanghai Jiao Tong Univ, Sch Med, Shanghai Mental Hlth Ctr, Mental Hlth Inst, Shanghai, Peoples R China Cent S Univ, Xiangya Hosp 2, Dept Psychiat, Changsha, Hunan, Peoples R China Kunming Med Univ, Affiliated Hosp 1, Dept Psychiat, Kunming, Yunnan, Peoples R China Sichuan Univ, West China Hosp, Dept Psychiat, Chengdu, Sichuan, Peoples R China Sumitomo Pharma Suzhou Co Ltd, Div Med, Beijing, Peoples R China |
| Keywords | EFFICACY OLANZAPINE SAFETY BURDEN TOLERABILITY BLONANSERIN PREVALENCE QUETIAPINE 12-MONTH DISEASE |
| Issue Date | Jan-2020 |
| Publisher | PSYCHIATRY AND CLINICAL NEUROSCIENCES |
| Abstract | Aim The aim of the present study was to evaluate the efficacy and safety of lurasidone for the treatment of Chinese schizophrenic patients. Methods Hospitalized schizophrenia patients aged 18-65 were randomized to 6 weeks of double-blind, double-dummy, flexible-dose treatment with lurasidone (40 or 80 mg/day) or risperidone (2, 4 or 6 mg/day). Efficacy was evaluated using a non-inferiority comparison of lurasidone relative to risperidone based on week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score. Safety assessments included adverse events, clinical laboratory measures, and electrocardiograms. Results Four hundred and forty-four patients were screened to obtain an intent-to-treat sample of 384 patients, of whom 54 patients discontinued treatment prior to 6 weeks. Lurasidone met the criteria for non-inferiority versus risperidone on the PANSS total score. Adjusted mean (SE) change at week 6 on the PANSS total score was -31.2 (1.0) and -34.9 (1.0) in the lurasidone and risperidone group, respectively. The mean difference score was 3.7, and the upper boundary of the 95%-confidence interval (1.0-6.3) was less than the prespecified margin of 7.0. No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales. The incidence of adverse events was lower for lurasidone vs risperidone for extrapyramidal symptoms (17.0% vs 38.2%), akathisia (7.2% vs 13.6%), prolactin increase (3.1% vs 14.1%), and weight increase (0.5% vs 5.2%). Conclusion Lurasidone was found to be non-inferior to risperidone on the primary endpoint with minimal effects on weight, metabolic parameters, or prolactin levels. |
| URI | http://hdl.handle.net/20.500.11897/606360 |
| ISSN | 1323-1316 |
| DOI | 10.1111/pcn.12965 |
| Indexed | SCI(E) |
| Appears in Collections: | 第六医院 |
