Citation

Si T, Zhuo J, Feng Y, Lu H, Hong D, Zhang L. Neuropsychiatr. Dis. Treat. 2019; 15: 1685-1694.

Copyright

(Copyright © 2019, Dove Press)

DOI

10.2147/NDT.S191803

PMID

unavailable

Abstract

BACKGROUND: The subgroup analysis of a primary study (NCT01051531) evaluated the effect of long-term paliperidone palmitate once-monthly (PP1M) therapy in Chinese patients with recent-onset schizophrenia responding unsatisfactorily to previous oral antipsychotics.

PATIENTS AND METHODS: This 18-month, open-label study consisted of 3 phases-screening (7 days), treatment (18 months) and end-of-study/withdrawal visit. All enrolled patients (18-50 years) received PP1M: 150 mg eq. (day 1), 100 mg eq. (day 8) followed by a oncemonthly flexible dose (50, 75, 100 or 150 mg eq.). Efficacy and safety were assessed.

RESULTS: Among the 118 enrolled Chinese patients, 68 completed the treatment (mean age: 25.6 years; male: 54.7%). A clinically meaningful change from baseline to day 548 was observed in Positive and Negative Syndrome scale (primary endpoint, mean [SD]: −15.3 [20.76]), Personal and Social Performance scale (15.9 [19.65]), Clinician Global Impressionschizophrenia score (−1.2 [1.54]) and Medication Satisfaction Questionnaire score (0.9 [1.73]). Commonly reported treatment-emergent adverse events (TEAEs) included insomnia (13.9%), injection-site pain (13.9%), upper respiratory tract infection (13.0%), restlessness (13.0%) and akathisia (13.0%). Serious TEAEs were reported in 9.3% patients with schizophrenia being most common (6.5%) and one death (suicide) was observed.

CONCLUSION: Efficacy of PP1M corroborate findings from earlier studies and no new safety concerns emerged in this Chinese subgroup of patients with schizophrenia. © 2019 Si et al.

Language: en

Keywords

adult; human; suicide; female; male; insomnia; Schizophrenia; schizophrenia; anxiety; psychosis; fatigue; major clinical study; vomiting; retrospective study; headache; somnolence; sleep disorder; constipation; drug safety; long term care; drug efficacy; tardive dyskinesia; diarrhea; nausea; tremor; akathisia; restlessness; side effect; dystonia; parkinsonism; Chinese; dizziness; increased appetite; auditory hallucination; Article; injection site pain; open study; Clinical Global Impression scale; upper respiratory tract infection; Positive and Negative Syndrome Scale; rhinopharyngitis; paliperidone; body weight gain; Long-acting injectable; adverse event; sinus arrhythmia; mental function assessment; muscle tightness; Chinese patients; Maintenance therapy; Medication Satisfaction Questionnaire score; Paliperidone palmitate once-monthly; Personal and Social Performance scale