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Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia

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机构: [1]Capital Med Univ, Beijing Anding Hosp, Dept Psychiat, Natl Clin Res Ctr Mental Disorders, Beijing, Peoples R China [2]Xian Mental Hlth Ctr, Dept Psychiat, Xian, Shaanxi, Peoples R China [3]Tianjin Anding Hosp, Dept Psychiat, Tianjin, Peoples R China [4]Wuxi Mental Hlth Ctr, Dept Psychiat, Wuxi, Jiangsu, Peoples R China [5]Beijing Huilongguan Hosp, Dept Psychiat, Beijing, Peoples R China [6]Henan Prov Mental Hosp, Dept Psychiat, Xinxiang, Henan, Peoples R China [7]Guangzhou Brain Hosp, Dept Psychiat, Guangzhou, Guangdong, Peoples R China [8]Nanjing Brain Hosp, Dept Psychiat, Nanjing, Jiangsu, Peoples R China [9]Brain Hosp Hunan Prov, Dept Psychiat, Changsha, Hunan, Peoples R China [10]Peking Univ, Hosp 6, Dept Psychiat, Beijing, Peoples R China [11]Hebei Mental Hlth Ctr, Dept Psychiat, Baoding, Peoples R China [12]Shanghai Jiao Tong Univ, Sch Med, Shanghai Mental Hlth Ctr, Mental Hlth Inst, Shanghai, Peoples R China [13]Cent South Univ, Xiangya Hosp 2, Dept Psychiat, Changsha, Hunan, Peoples R China [14]Kunming Med Univ, Affiliated Hosp 1, Dept Psychiat, Kunming, Yunnan, Peoples R China [15]Sichuan Univ, West China Hosp, Dept Psychiat, Chengdu, Sichuan, Peoples R China [16]Sumitomo Pharma Suzhou Co Ltd, Div Med, Beijing, Peoples R China
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关键词: atypical antipsychotics lurasidone non-inferiority trial risperidone schizophrenia

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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.

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出版当年[2021]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学 3 区 精神病学
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学 3 区 精神病学
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出版当年[2020]版:
Q1 CLINICAL NEUROLOGY Q1 PSYCHIATRY Q2 NEUROSCIENCES
最新[2023]版:
Q1 CLINICAL NEUROLOGY Q1 NEUROSCIENCES Q1 PSYCHIATRY

影响因子: 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

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第一作者机构: [1]Capital Med Univ, Beijing Anding Hosp, Dept Psychiat, Natl Clin Res Ctr Mental Disorders, Beijing, Peoples R China
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通讯机构: [1]Capital Med Univ, Beijing Anding Hosp, Dept Psychiat, Natl Clin Res Ctr Mental Disorders, Beijing, Peoples R China
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