{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T02:54:02Z","timestamp":1791428042053,"version":"4.3.3"},"reference-count":46,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>Long-acting injectable (LAI) antipsychotics have the potential to improve adherence and symptom control in patients with schizophrenia, promoting long-term recovery. Paliperidone palmitate (PP) once every 6 months is the first and currently only LAI antipsychotic with an extended dosing interval of 6 months.<\/jats:p><\/jats:sec>Objective<\/jats:title>To assess long-term outcomes of PP received once every 6 months in adults with schizophrenia.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>In a 2-year open-label extension (OLE) study of a 1-year randomized clinical trial (RCT), eligible adults with schizophrenia could choose to continue PP every 6 months if they had not experienced relapse after receiving PP once every 3 or 6 months in the 1-year, international, multicenter, double-blind, randomized noninferiority trial. The present analysis focused on patients receiving PP every 6 months in the double-blind trial through the OLE study (November 20, 2017, to May 3, 2022).<\/jats:p><\/jats:sec>Intervention<\/jats:title>Patients received a dorsogluteal injection of PP on day 1 and once every 6 months up to month 30.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>End points included assessment of relapse and change from the double-blind trial baseline to the OLE end point in Positive and Negative Syndrome Scale (PANSS) total and subscale, Clinical Global Impression\u2013Severity (CGI-S) Scale, and Personal Social Performance (PSP) Scale scores. Treatment-emergent adverse events (TEAEs), injection site evaluations, and laboratory tests were also assessed.<\/jats:p><\/jats:sec>Results<\/jats:title>Among 121 patients (83 [68.6%] male), mean (SD) age at baseline was 38.6 (11.24) years and mean (SD) duration of illness was 11.0 (9.45) years. At screening of the double-blind study, 101 patients (83.5%) were taking an oral antipsychotic and 20 (16.5%) were taking an LAI antipsychotic. Altogether, 5 of 121 patients (4.1%) experienced relapse during the 3-year follow-up; reasons for relapse were psychiatric hospitalization (2 [1.7%]), suicidal or homicidal ideation (2 [1.7%]), and deliberate self-injury (1 [0.8%]). Patients treated with PP every 6 months were clinically and functionally stable, and outcomes were well maintained, evidenced by stable scores on the PANSS (mean [SD] change, \u22122.6 [9.96] points), CGI-S (mean [SD] change, \u22120.2 [0.57] points), and PSP (mean [SD] change, 3.1 [9.14] points) scales over the 3-year period. In total, 101 patients (83.5%) completed the 2-year OLE. At least 1 TEAE was reported in 97 of 121 patients (80.2%) overall; no new safety or tolerability concerns were identified.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In a 2-year OLE study of a 1-year RCT, results supported favorable long-term outcomes of PP once every 6 months for up to 3 years in adults with schizophrenia.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.21495","type":"journal-article","created":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T15:01:16Z","timestamp":1721228476000},"page":"e2421495","source":"Crossref","is-referenced-by-count":14,"title":["Three-Year Outcomes of 6-Month Paliperidone Palmitate in Adults With Schizophrenia"],"prefix":"10.1001","volume":"7","author":[{"given":"Christoph U.","family":"Correll","sequence":"first","affiliation":[{"name":"Department of Psychiatry, Zucker Hillside Hospital, Glen Oaks, New York"},{"name":"Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of 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