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学科主题: 精神卫生
题名:
Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study
作者: Si, Tianmei1; Zhang, Kerang2; Tang, Jisheng3; Fang, Maosheng4; Li, Keqing5; Zhuo, Jianmin6; Feng, Yu6
关键词: antipsychotic ; long-acting injectable ; PANSS
刊名: NEUROPSYCHIATRIC DISEASE AND TREATMENT
发表日期: 2015
DOI: 10.2147/NDT.S81760
卷: 11, 页:1483-1492
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Clinical Neurology ; Psychiatry
研究领域[WOS]: Neurosciences & Neurology ; Psychiatry
关键词[WOS]: ANTIPSYCHOTIC AGENTS ; DOUBLE-BLIND ; RISPERIDONE ; RELAPSE ; TOLERABILITY ; PREVENTION ; TRIAL ; TIME
英文摘要:

This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75-150 mg eq, deltoid/gluteal injection) in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score. 70), who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period). Primary efficacy endpoint was percentage of patients with >= 30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions-Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2%) completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years). Total, 443/610 (72.6%, full analysis set) patients achieved primary endpoint (mean [standard deviation] change from baseline: -30.9 [19.51]). All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (>5%) treatment-emergent adverse events were extrapyramidal disorders (8.4%). The efficacy and safety data are consistent with other short-term, placebo-controlled studies of paliperidone palmitate conducted in similar populations.

语种: 英语
项目资助者: Xi&prime ; an Janssen Pharmaceutical Ltd (Beijing, People&prime ; s Republic of China)
WOS记录号: WOS:000356594900001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/56178
Appears in Collections:北京大学精神卫生研究所_期刊论文

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作者单位: 1.Peking Univ, Inst Mental Hlth, Key Lab Mental Hlth, Minist Hlth, Beijing 100871, Peoples R China
2.Shanxi Med Univ, Hosp 1, Taiyuan, Shanxi, Peoples R China
3.Mental Hlth Ctr Shandong Prov, Jinan, Shandong, Peoples R China
4.Huazhong Univ Sci & Technol, Tongji Med Coll, Mental Hlth Ctr, Wuhan, Hubei, Peoples R China
5.Mental Hlth Ctr Hebei Prov, Baoding, Hebei, Peoples R China
6.Janssen Res & Dev, Beijing, Peoples R China

Recommended Citation:
Si, Tianmei,Zhang, Kerang,Tang, Jisheng,et al. Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study[J]. NEUROPSYCHIATRIC DISEASE AND TREATMENT,2015,11:1483-1492.
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