To explore functioning in adult patients with recently diagnosed (< 5 years) and more chronic (> 5 years) schizophrenia treated with flexible doses of paliperidone ER.

International prospective open-label 6-month study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), patient functioning (Personal and Social Performance Scale; PSP) and treatment-emergent adverse events (TEAEs).

Of 713 recently diagnosed patients, most were male (60.9%), mean age was 33.6 ± 11.2 years and mean time since diagnosis was 2.3 ± 1.7 years. Chronic patients (n = 1003) were predominantly male (59.2%) with a mean age of 43.8 ± 11.4 and mean time since diagnosis of 15.6 ± 9.2 years. Mean mode doses of paliperidone ER were similar between recently diagnosed and chronic patients (7.0 ± 2.9 mg/day and 7.2 ± 2.9 mg/day). At endpoint PANSS total scores were improved by 13.7 and 12.9 points, respectively, in recently diagnosed and chronic patients. The rate of patients with mild or less functional impairment increased from 17.7% to 39.8% in recently diagnosed and from 14.4% to 32.9% in chronic patients. Major functional improvements were observed for socially useful activities and personal and social relationships. TEAEs reported in >5% of recently diagnosed or chronic patients were insomnia (10.7% and 8.1%), anxiety (8.6% and 6.0%) and somnolence (5.8% and 3.4%), respectively.

These data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with other oral antipsychotics may benefit from paliperidone ER, with a tendency for recently diagnosed patients showing some higher treatment response in psychotic symptoms and patient functioning, particularly in socially useful activities and personal and social relationships.