Citation

Si T, Zhang K, Tang J, Fang M, Li K, Zhuo J, Feng Y. Neuropsychiatr. Dis. Treat. 2015; 11: 1483-1492.

Copyright

(Copyright © 2015, Dove Press)

DOI

10.2147/NDT.S81760

PMID

unavailable

Abstract

This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75-150 mg eq, deltoid/gluteal injection) in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score ≥70), who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period). Primary efficacy endpoint was percentage of patients with ≥30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions-Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2%) completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years). Total, 443/610 (72.6%, full analysis set) patients achieved primary endpoint (mean [standard deviation] change from baseline: -30.9 [19.51]). All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (<5%) treatment-emergent adverse events were extrapyramidal disorders (8.4%). The efficacy and safety data are consistent with other short-term, placebo-controlled studies of paliperidone palmitate conducted in similar populations. © 2015 Si et al.

Language: en

Keywords

adult; human; female; male; aged; insomnia; depression; schizophrenia; suicide attempt; clinical trial; acne; major clinical study; neuroleptic agent; weight reduction; quetiapine; constipation; intervention study; drug safety; drug efficacy; olanzapine; risperidone; drug tolerability; tremor; weight gain; extrapyramidal syndrome; drug withdrawal; hyperprolactinemia; multicenter study; akathisia; lorazepam; restlessness; muscle hypertonia; prospective study; side effect; dystonia; hematuria; menstrual irregularity; parkinsonism; alanine aminotransferase; aspartate aminotransferase; clonazepam; dose response; Chinese; lung infection; bradycardia; auditory hallucination; herbaceous agent; menstruation disorder; dyskinesia; Article; Antipsychotic; outcome assessment; musculoskeletal stiffness; drug treatment failure; treatment duration; trihexyphenidyl; open study; Clinical Global Impression scale; alanine aminotransferase blood level; aspartate aminotransferase blood level; upper respiratory tract infection; hyperkinesia; Positive and Negative Syndrome Scale; sinus bradycardia; ECG abnormality; oligomenorrhea; paliperidone; DSM-IV-TR; Long-acting injectable; assessment of humans; Personal and Social Performance Scale; Marder factor score; PANSS