Citation

Nakagawa R, Ohnishi T, Kobayashi H, Wakamatsu A, Tanimura A, Morita K, Yamaoka T, Usui H, Ogawa Y, Fujino A, Yoshizawa K. Neuropsychiatr. Dis. Treat. 2015; 11: 1511-1521.

Copyright

(Copyright © 2015, Dove Press)

DOI

10.2147/NDT.S85891

PMID

unavailable

Abstract

BACKGROUND: Social functioning is an important outcome for patients with schizophrenia. To evaluate the effects of paliperidone extended-release (PAL-ER) on social function, symptomatology, and safety in the routine clinical practice, we conducted a 1-year post-marketing surveillance study of PAL-ER. We also explored relationships between symptomatic improvement and socially functional outcome in patients with schizophrenia.

PATIENTS AND METHODS: Patients with an established diagnosis of schizophrenia were allowed flexible 3-12 mg/day dosing during the surveillance. Patients were assessed on social functioning using the Social and Occupational Functioning Assessment Scale (SOFAS) and on symptomatology using the Clinical Global Impression-Schizophrenia scale. All adverse events (AEs) were also collected.

RESULTS: A total of 1,429 patients were enrolled in the surveillance study, of whom 1,405 were evaluable for safety and 1,142 were evaluable for efficacy. The treatment discontinuation rate for any reason during the observation period was 34.66%. Significant improvements were observed on both Social and Occupational Functioning Assessment Scale and Clinical Global Impression-Schizophrenia scale during the observation period. The percentage of patients with socially functional remission (SOFAS ≥61) also increased significantly. A significant association between early improvements in positive symptoms, sex, severity of negative symptoms at baseline, and socially functional remission was observed. A total of 33.52% of patients had AEs and 8.75% of patients had serious AEs. Despite the recommendation of monotherapy with PAL-ER, 65.84% of patients were given additional antipsychotics (polypharmacy). Post hoc comparisons of monotherapy versus polypharmacy revealed that the monotherapy group had better outcomes and fewer AEs than the polypharmacy treated group. The improvement in social functioning and the rate of socially functional remission did not differ between groups.

CONCLUSION: PAL-ER treatment showed effective symptom control and improvement in social functioning. The data suggest that early response to antipsychotic treatment should be important for functional outcomes. © 2015 Nakagawa et al.

Language: en

Keywords

adult; human; social interaction; age; suicide; female; male; insomnia; Schizophrenia; sex difference; schizophrenia; anxiety; treatment outcome; disease severity; polypharmacy; major clinical study; mental disease; controlled study; prolactin; prolactin blood level; hallucination; somnolence; paranoia; middle aged; delusion; drug safety; drug efficacy; tardive dyskinesia; tremor; weight gain; extrapyramidal syndrome; hypersalivation; negative syndrome; drug withdrawal; hyperprolactinemia; akathisia; irritability; paranoid schizophrenia; side effect; glucose blood level; drug surveillance program; dystonia; parkinsonism; glucose; remission; disease control; malaise; pneumonia; intestine obstruction; monotherapy; polydipsia; body mass; auditory hallucination; neuroleptic malignant syndrome; Article; outcome assessment; Clinical Global Impression scale; correlational study; Social and Occupational Functioning Assessment Scale; paliperidone; Paliperidone; femur fracture; Naturalistic study; pulmonary aspiration; Social function