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

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.

Figure 1

Patient Disposition. A total of 480 patients were enrolled. Among them, a total of 426 subjects (88.8%) had evaluation at week 4 and 350 (72.9%) completed the 12-week evaluation. The details of patient disposition are summarized.

Figure 2

Summary of switching reasons of previous antipsychotic treatment of all enrolled patients. For the enrolled population, there were 9 subjects who did not receive any antipsychotics at enrollment. For the remaining 471 subjects, 449 received antipsychotics within 30 days prior to enrollment. The treatments included oral risperidone for 201 subjects (44.77%), olanzapine for 41 subjects (9.13%), quetiapine for 31 subjects (6.90%), aripiprazole for 30 subjects (6.68%), and other treatments for 187 subjects (41.65%). The major reason of switching treatment was insufficient efficacy, accounting for a total of 344 subjects. AEs (92 subjects), noncompliance (51 subjects), and other (2 subjects) were the reasons for switching. Twenty-two subjects received antipsychotics > 30 days prior to enrollment. The switching reasons were insufficient efficacy (n = 10), side effects (n = 1), noncompliance (n = 11), and other (n = 1).

Figure 3

Summary of switching reasons of previous antipsychotic treatment of ITT population. For the ITT population, there were 4 subjects who did not receive any antipsychotics at enrollment. For the remaining 422 subjects, 409 received antipsychotics within 30 days prior to enrollment. The treatments included oral risperidone for 188 subjects (45.97%), olanzapine for 40 subjects (9.78%), quetiapine for 29 subjects (7.09%), aripiprazole for 28 subjects (6.85%), and other treatments for 166 subjects (40.59%). The major reason of switching treatment was insufficient efficacy, accounting for a total of 321 subjects. AEs (82 subjects), noncompliance (42 subjects), and other (2 subjects) were the reasons for switching. Thirteen subjects received antipsychotics > 30 days prior to enrollment. The switching reasons were insufficient efficacy (n = 7), noncompliance (n = 6), and other (n = 1).

Figure 4

Summary of Efficacy Result. The symptomatic remission rate was 3.5% (95%CI, 1.98%, 5.74%) at baseline and improved to 11.7% (95%CI, 8.84%, 15.18%) at the end of study (p < 0.05). The criteria for PSP improvement was at least one 10-point interval on PSP scale. In the ITT population, subjects showed an increasing PSP improvement after treatment began. The improvement rate was increased from 28.1% (95%CI, 23.94%, 32.70%) at week 4 to 47.4% (95%CI, 42.59%, 52.28%) at the end of study.