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Open Access Research article

Effects of paliperidone extended release on the symptoms and functioning of schizophrenia

Min-Wei Huang12, Tsung-Tsair Yang3, Po-Ren Ten4, Po-Wen Su5, Bo-Jian Wu6, Chin-Hong Chan7, Tsuo-Hung Lan7, I-Chao Liu3, Wei-Cheh Chiu8, Chun-Ying Li1, Kuo-Sheng Cheng19 and Yu-Chi Yeh8*

Author Affiliations

1 Institute of Biomedical Engineering, National Cheng Kung University, Tainan 70403, Taiwan

2 Department of Psychiatry, Chiayi Branch, Taichung Veterans General Hospital, Chia-Yi 60090, Taiwan

3 Department of Psychiatry, Cardinal Tien Ken-Sin Hospital, Taipei 23148, Taiwan

4 Department of Psychiatry, Show Chwan Memorial Hospital, Changhua 50008, Taiwan

5 Department of Psychiatry, Chu-Tung Branch, National Taiwan University Hospital, Hsinchu 31064, Taiwan

6 Department of Psychiatry, Yuli Hospital, Hualien 98147, Taiwan

7 Department of Psychiatry, Taichung Veterans General Hospital, Taichung 40705, Taiwan

8 Department of Psychiatry, Cathay General Hospital, Taipei 10630, Taiwan

9 Medical Devices Innovation Center, National Cheng Kung University, Tainan 70403, Taiwan

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BMC Clinical Pharmacology 2012, 12:1  doi:10.1186/1472-6904-12-1

Published: 6 January 2012

Abstract

Background

We aimed to explore relations between symptomatic remission and functionality evaluation in schizophrenia patients treated with paliperidone extended-release (ER), as seen in a normal day-to-day practice, using flexible dosing regimens of paliperidone ER. We explored symptomatic remission rate in patients treated with flexibly dosed paliperidone ER by 8 items of Positive and Negative Syndrome Scale (PANSS) and change of Personal and Social Performance (PSP) scale.

Method

This was a 12-week multicenter, open-label, prospective clinical study conducted in in-patient and out-patient populations. Flexible dosing in the range 3-12 mg/day was used throughout the study. All subjects attended clinic visits on weeks 0, 4, 8, and 12 as usual clinical practice for the 12-week observation period. Data were summarized with respect to demographic and baseline characteristics, efficacy measurement with PANSS scale, PSP, and social functioning score, and safety observations. Descriptive statistics were performed to identify the retention rate at each visit as well as the symptomatic remission rate. Summary statistics of average doses the subjects received were based on all subjects participating in the study.

Results

A total of 480 patients were enrolled. Among them, 426 patients (88.8%) had evaluation at week 4 and 350 (72.9%) completed the 12-week evaluation. Patients with at least moderate severity of schizophrenia were evaluated as "mild" or better on PANSS scale by all 8 items after 12 weeks of treatment with paliperidone ER. There was significant improvement in patients' functionality as measured by PSP improvement and score changes. Concerning the other efficacy parameters, PANSS total scale, PSP total scale, and social functioning total scale at the end of study all indicated statistically significant improvement by comparison with baseline. The safety profile also demonstrated that paliperidone ER was well-tolerated without clinically significant changes after treatment administration.

Conclusions

Although the short-term nature of this study may limit the potential for assessing improvements in function, it is noteworthy that in the present short-term study significant improvements in patient personal and social functioning with paliperidone ER treatment were observed, as assessed by PSP scale.

Trial Registration

Clinical Trials. PAL-TWN-MA3