Effects of Paliperidone Extended Release on the Symptoms and Functioning of Schizophrenia

Topics: Schizophrenia, Antipsychotic, Clinical trial Pages: 16 (5271 words) Published: June 23, 2013
Huang et al. BMC Clinical Pharmacology 2012, 12:1 http://www.biomedcentral.com/1472-6904/12/1


Open Access

Effects of paliperidone extended release on the symptoms and functioning of schizophrenia Min-Wei Huang1,2, 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 Cheng1,9 and Yu-Chi Yeh8*

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 outpatient 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

Background Schizophrenia is a severe form of mental illness affecting about 24 million people worldwide (7 per 1000 adult population), mostly in the age group 15-35 years. Although the incidence is low (3/10,000), the prevalence is high due to chronicity [1]. Deficits in social functioning can be observed throughout the course of * Correspondence: yeh.yuchi@gmail.com 8 Department of Psychiatry, Cathay General Hospital, Taipei 10630, Taiwan Full list of author information is available at the end of the article

schizophrenia: in the early stages, during acute exacerbations, and over long-term maintenance treatment. The early course of schizophrenia typically includes a prodromal phase characterized by nonspecific symptoms and behaviors, a formal onset/deteriorative stage with active psychosis, cognitive impairment, negative symptoms, and social deficits, and a period of several years following the initial episode that often includes repeated episodes of psychosis with a progressive increase in residual symptoms and functional decline. There is general

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