|An open-label, flexible-dose study of paliperidone extended-release in Chinese patients with first-onset psychosis|
|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|
|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|
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.
|项目编号||20112X09302-004 ; 81171284|
|资助机构||Xian-Janssen Pharmaceutical Ltd ; National Science and Technology Major Projects for "Major New Psychiatric Drugs Innovation and Development" ; National Natural Science Foundation of China|
|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
|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.|
|APA||Si, TianMei,Tan, QingRong,Zhang, KeRang,Wang, Yang,&Rui, Qing.(2015).An open-label, flexible-dose study of paliperidone extended-release in Chinese patients with first-onset psychosis.NEUROPSYCHIATRIC DISEASE AND TREATMENT,11,87-95.|
|MLA||Si, TianMei,et al."An open-label, flexible-dose study of paliperidone extended-release in Chinese patients with first-onset psychosis".NEUROPSYCHIATRIC DISEASE AND TREATMENT 11(2015):87-95.|