12-Month mirror study on the effectiveness and safety of six-month paliperidone palmitate in patients with schizophrenia: A Multicenter Andalusian Cohort (PAPSEM study)
Year: 2025
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Paliperidone palmitate 6-month formulation (PP6M) offers a promising alternative for maintaining treatment adherence and reducing relapse risk in patients with schizophrenia. However, real-world data on its long-term effectiveness and safety remains limited. AIMS: To evaluate the effectiveness and safety of PP6M in a real-world setting over 12 months in patients with schizophrenia previously stabilized on monthly (PP1M) or 3-monthly (PP3M) formulations. METHODS: This was a multicenter, ambispective mirror-image study conducted across 10 Community Mental Health Units in Spain. A total of 158 patients with schizophrenia who switched from PP1M or PP3M to PP6M were followed at baseline, 6 months, and 12 months. Effectiveness was assessed through hospitalization rates, Clinical Global Impression (CGI), and Sheehan Disability Scale (SDS) scores. Safety, adverse effects, and substance use were also analyzed. RESULTS: A significant reduction in hospitalization was observed at 6 and 12 months compared to the prior year. CGI and SDS scores improved significantly over time. Patient retention at 12 months was 83%, resulting in a dropout rate of 17%. The primary reasons for dropout were clinical relapse (40.7%) and patient refusal (29.6%). Adverse events were reported in 38.2% of patients, mostly mild or moderate. A significant reduction in substance use, particularly cocaine, was also noted. Acceptance of PP6M was high, with nursing staff playing a key role in facilitating the transition. CONCLUSIONS: PP6M is an effective and well-tolerated option for patients with schizophrenia in real-world clinical practice. It reduces hospitalizations, improves clinical outcomes, and may contribute to decreased substance use.
Source: Psychiatry Research
Authors: Jesús García-Jiménez, Óscar Lafuente-Casanova, Rosario Salas, Carlota Rodríguez, Miguel Graciani-Pérez, Pablo Roque Leonardo-Caserta, Manuel López-Arroyo, Asunta Torres-Laborde, Luis Gutiérrez-Rojas
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,230
OpenAlex ID: W4417264604