Efficacy and safety of paliperidone palmitate 1-month formulation (PP1M) for schizophrenia in southwestern China.

Abstract

Background: This clinical pilot initiative, led by the Sichuan Provincial Government in western China, aims to develop an innovative model for "integrated hospital-community management and treatment of severe mental disorders" to enhance the management of patients with such conditions. This single-arm, open-label, prospective, multicenter, interventional study was designed to evaluate the efficacy and safety of paliperidone palmitate 1-month formulation (PP1M) in patients with schizophrenia.

Methods: The study enrolled patients with schizophrenia aged 18-55 from all 21 prefectural-level municipalities in Sichuan Province, southwestern China, who received PP1M at doses of 75, 100, or 150 mg. Efficacy and social functioning were assessed using the PANSS and SDSS scales at baseline and after the 3rd, 6th, and 9th injections. The SF-12 scale was administered at baseline and at 6 months, while satisfaction (MSQ) was measured at 1, 3, 6, and 9 months. The TESS scale was performed at the 1st, 3rd, 6th, and 9th doses, with adverse events (AEs) monitored after the 1st, 2nd, 3rd, and 9th doses to evaluate safety.

Results: A total of 2268 patients were enrolled, with 1491 completing the 9th injection. The numbers of patients completing the PANSS, SDSS, SF-12, MSQ, and TESS scales were 1151, 1158, 1043, 827, and 1158, respectively. Following multiple PP1M doses, total PANSS scores, positive symptom subscale scores, negative symptom subscale scores, general psychopathological subscale scores, and SDSS scores significantly decreased compared to baseline (P < 0.05), while SF-12 and MSQ scores significantly increased (P < 0.05). The PANSS total response rates were 64.90% (747/1151), 74.63% (859/1151), and 78.71% (906/1151) after the 3rd, 6th, and 9th injections, respectively. TESS scores significantly decreased compared to the first injection (P < 0.05), reflecting a lower incidence of AEs. Common adverse reactions, including tremors, muscle tension, dizziness, and fatigue, were mild to moderate in severity.

Conclusions: These findings indicate that PP1M significantly alleviates psychotic symptoms in patients with schizophrenia, accelerates social function recovery, and improves quality of life and patient satisfaction. Furthermore, PP1M demonstrates improved tolerability, fewer adverse reactions, and no new drug-related safety concerns.