Correll, Christoph U.Rohner, HenrikDimalta, SavinoGöldner, Randi SusanneAssion, Hans JörgLangner-Timm, SteffiNúñez Sande, CarmenRodriguez-Jimenez, RobertoBioque, MiquelGahr, MaximilianMesser, ThomasFalkai, PeterHeres, StephanLandry, ChristopherSchöttle, DanielBernardo, MiquelCaballero, MontserratGonzález-Pinto, AnaMolina, RosaDe Giorgi, SerafinoMaina, GiuseppeVita, AntonioVieira Coelho, María AugustaGago, JoaquimMadeira, NunoDratcu, LuizFarooq, SaeedFernández-Egea, EmilioPappa, SofiaAnta Carabias, LourdesSánchez-García, SheilaMartínez-González, Javier2026-03-132026-03-1320261562-2975PURE: 156250442PURE UUID: dc91a4d8-a6fd-4765-90fc-b30e20988d52Scopus: 105031395685PubMed: 41734274http://hdl.handle.net/10362/201411Publisher Copyright: © 2026 Laboratorios Farmacéuticos ROVI, S.A. Published by Informa UK Limited, trading as Taylor & Francis Group.Objective: To evaluate the effectiveness, time to discharge, functioning, and tolerability of Risperidone-ISM® in hospitalised patients with schizophrenia relapse. Methods: Non-interventional, multicentre, prospective study of adults admitted for acute exacerbation of schizophrenia and treated with Risperidone-ISM®. Effectiveness was assessed using the Clinical Global Impression-Severity scale (CGI-S) and 6-item Positive and Negative Syndrome Scale (PANSS-6) at days 8 (FU1), 28 (FU2), and 56 (FV). Functioning was evaluated with the Personal and Social Performance scale (PSP), patient satisfaction with the Medication Satisfaction Questionnaire (MSQ). Admission/discharge data and adverse events were recorded. Results: In 275 patients, significant reductions from baseline in CGI-S and PANSS-6 scores occurred as early as day 8, with continued improvement through day 56 (CGI-S: −1.4 and PANSS-6: −7.6; p < 0.0001), regardless of use of concomitant antipsychotics. Median discharge occurred 8 days after first Risperidone-ISM® injection. PSP improved by 17.6 points at day 28. No new/unexpected safety information was reported; 4% discontinued due to related adverse events. At final visit, 78% reported satisfaction with treatment, and therapeutic alliance improved in 89.4% of participants. Conclusions: Risperidone-ISM® demonstrated rapid and sustained effectiveness, functional improvement, and favourable tolerability, enabling early stabilisation and discharge. Adding another antipsychotic provided no additional benefits. Results support Risperidone-ISM® for treating acute schizophrenia relapse in real-world settings.2779822engacute exacerbationlong-acting injectablereal-life settingRisperidone ISMschizophreniaPsychiatry and Mental healthBiological PsychiatrySDG 3 - Good Health and Well-beingjournal article10.1080/15622975.2026.2628198https://www.scopus.com/pages/publications/105031395685