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


METHODS
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.


BACKGROUND
Clinical Trials. PAL-TWN-MA3.
Institute of Biomedical Engineering, National Cheng Kung University, Tainan 70403, Taiwan.
Min-Wei
MW
Huang
Tsung-Tsair
TT
Yang
Po-Ren
PR
Ten
Po-Wen
PW
Su
Bo-Jian
BJ
Wu
Chin-Hong
CH
Chan
Tsuo-Hung
TH
Lan
I-Chao
IC
Liu
Wei-Cheh
WC
Chiu
Chun-Ying
CY
Li
Kuo-Sheng
KS
Cheng
Yu-Chi
YC
Yeh
D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000494:pharmacology; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage* / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage* / Q000494:pharmacology; D012074:Remission Induction; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D011743:Pyrimidines; D000068882:Paliperidone Palmitate