ORIGINAL RESEARCH article
Front. Psychiatry
Sec. Schizophrenia
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1606320
Gender-Stratified 9-Month Comparison of Paliperidone Extended-Release Tablets and Paliperidone Palmitate Injection in Schizophrenia
Provisionally accepted
- 1First People's Hospital of Foshan, Foshan, China
- 2Xinshi Hospital, Gaoming District, Foshan, Foshan, Guangdong Province, China
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Background: Gender differences in antipsychotic efficacy for schizophrenia (SCZ) remain understudied despite evidence of sex-dependent pharmacokinetic, neurobiological, and social factors influencing outcomes. This trial compared 9 - month efficacy and tolerability of paliperidone palmitate injection 1-monthly (PP1M) versus extended-release tablets in male and female patients with SCZ, with a focus on gender-stratified results.Methods: This randomized, open-label study enrolled 118 adult patients (61 males, 57 females) diagnosed with SCZ. Participants were randomized (1:1) to receive either paliperidone extended-release (ER) tablets (titrated 3–12 mg/day) or PP1M (3–9 mg monthly). Efficacy was assessed via PANSS total scores and CGI-S severity ratings at 3, 6, and 9 months. Safety was evaluated using the TESS scale.Results: Gender-stratified analysis revealed superior long-term efficacy for males treated with paliperidone palmitate injection. Males treated with PP1M demonstrated significantly greater reductions in PANSS scores (mean difference at 9 months: -7.44; p < 0.05) and CGI-S severity compared to ER therapy. Females showed no statistically significant differences between formulations at any time point, with overlapping confidence intervals (e.g., PANSS mean difference at 9 months: +3.16; p > 0.05). Both groups exhibited comparable tolerability, with minimal adverse events.Conclusion: Gender-informed treatment strategies are critical in SCZ management. PP1M appears advantageous for males seeking long-term symptom stabilization, while treatment selection for females may prioritize lifestyle factors. These findings underscore the need for sex-stratified analysis in antipsychotic trials and the importance of tailored interventions to address sex-based disparities in psychiatric care.
Keywords: Schizophrenia, Paliperidone, gender differences, long-acting injectables, efficacy
Received: 05 Apr 2025; Accepted: 09 May 2025.
Copyright: © 2025 Huang, Lan, Long, Jiang and Huang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Wei Huang, First People's Hospital of Foshan, Foshan, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.