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学科主题: 精神卫生
题名:
An open-label, flexible-dose study of paliperidone extended-release in Chinese patients with first-onset psychosis
作者: Si, TianMei1; Tan, QingRong2; Zhang, KeRang3; Wang, Yang4; Rui, Qing4
关键词: paliperidone ; first-episode psychosis ; Personal and Social Performance score
刊名: NEUROPSYCHIATRIC DISEASE AND TREATMENT
发表日期: 2015
DOI: 10.2147/NDT.S70694
卷: 11, 页:87-95
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]: 1ST-EPISODE SCHIZOPHRENIA ; POOLED DATA ; EFFICACY ; TABLETS ; RISPERIDONE ; 6-WEEK ; SAFETY ; TRIAL ; ER
英文摘要:

Background: Antipsychotic medications facilitate the improvement of psychotic symptoms in patients with first-episode psychosis. Paliperidone extended-release (pali-ER), an atypical antipsychotic, was assessed for efficacy and safety in Chinese patients with first-episode psychosis.

Methods: In this 8-week, open-label, single-arm, multicenter study, patients with first-episode psychosis (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) and a Positive and Negative Syndrome Scale (PANSS) total score >= 70 were treated with flexible-dose pali-ER tablets (3-12 mg/day). The primary efficacy endpoint was the percentage of patients with an increase of >= 8 points in Personal and Social Performance (PSP) score from baseline to day 56 (8 weeks). Secondary endpoints included reduction in PANSS total score, improvement in Clinical Global Impression-Severity score, PSP score, Subjective Well-being under Neuroleptics Scale score, and relationship between duration of untreated psychosis and PANSS or PSP. Incidences of treatment-emergent adverse events were used to evaluate safety.

Results: Overall, 283 of 294 patients (96%) achieved a >= 8-point increase in PSP (primary endpoint, analysis set). For the secondary efficacy endpoints, 284/306 patients (93%) had a >= 30% reduction in PANSS total score; 266/306 patients (87%) achieved a <= 3 Clinical Global Impression-Severity scale score, and 218/294 patients (74%) had a PSP score >= 71. The Subjective Well-being under Neuroleptics Scale score was improved from a baseline mean of 72.7 to 94.7 at endpoint. There was a negative correlation between duration of untreated psychosis and posttreatment PSP score and a positive correlation with posttreatment PANSS total score. The most common treatment-emergent adverse events were extrapyramidal symptoms (12%), and agitation, somnolence, and xerostomia (4% each).

Conclusion: An 8-week, flexible-dose (3-12 mg/day) treatment with pali-ER resulted in significant improvements in psychotic symptoms and was generally tolerable.

语种: 英语
所属项目编号: 20112X09302-004 ; 81171284
项目资助者: Xian-Janssen Pharmaceutical Ltd ; National Science and Technology Major Projects for "Major New Psychiatric Drugs Innovation and Development" ; National Natural Science Foundation of China
WOS记录号: WOS:000347386000001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/59232
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.Shanxi Med Univ, Hosp 1, Taiyuan, Shanxi, Peoples R China
2.Janssen Res & Dev, Beijing, Peoples R China
3.Peking Univ, Inst Mental Hlth, Key Lab Mental Hlth, Minist Hlth, Beijing 100191, Peoples R China
4.Fourth Mil Med Univ, Hosp 1, Xian 710032, Peoples R China

Recommended Citation:
Si, TianMei,Tan, QingRong,Zhang, KeRang,et al. An open-label, flexible-dose study of paliperidone extended-release in Chinese patients with first-onset psychosis[J]. NEUROPSYCHIATRIC DISEASE AND TREATMENT,2015,11:87-95.
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