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Risperidone-ISM® effectiveness and tolerability in acute schizophrenia patients hospitalised due to a relapse

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dc.contributor.authorCorrell, Christoph U.
dc.contributor.authorRohner, Henrik
dc.contributor.authorDimalta, Savino
dc.contributor.authorGöldner, Randi Susanne
dc.contributor.authorAssion, Hans Jörg
dc.contributor.authorLangner-Timm, Steffi
dc.contributor.authorNúñez Sande, Carmen
dc.contributor.authorRodriguez-Jimenez, Roberto
dc.contributor.authorBioque, Miquel
dc.contributor.authorGahr, Maximilian
dc.contributor.authorMesser, Thomas
dc.contributor.authorFalkai, Peter
dc.contributor.authorHeres, Stephan
dc.contributor.authorLandry, Christopher
dc.contributor.authorSchöttle, Daniel
dc.contributor.authorBernardo, Miquel
dc.contributor.authorCaballero, Montserrat
dc.contributor.authorGonzález-Pinto, Ana
dc.contributor.authorMolina, Rosa
dc.contributor.authorDe Giorgi, Serafino
dc.contributor.authorMaina, Giuseppe
dc.contributor.authorVita, Antonio
dc.contributor.authorVieira Coelho, María Augusta
dc.contributor.authorGago, Joaquim
dc.contributor.authorMadeira, Nuno
dc.contributor.authorDratcu, Luiz
dc.contributor.authorFarooq, Saeed
dc.contributor.authorFernández-Egea, Emilio
dc.contributor.authorPappa, Sofia
dc.contributor.authorAnta Carabias, Lourdes
dc.contributor.authorSánchez-García, Sheila
dc.contributor.authorMartínez-González, Javier
dc.contributor.institutionNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
dc.contributor.pblInforma Healthcare
dc.date.accessioned2026-03-13T17:38:05Z
dc.date.available2026-03-13T17:38:05Z
dc.date.issued2026
dc.descriptionPublisher Copyright: © 2026 Laboratorios Farmacéuticos ROVI, S.A. Published by Informa UK Limited, trading as Taylor & Francis Group.
dc.description.abstractObjective: 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.en
dc.description.versionpublishersversion
dc.description.versioninpress
dc.format.extent2779822
dc.identifier.doi10.1080/15622975.2026.2628198
dc.identifier.issn1562-2975
dc.identifier.otherPURE: 156250442
dc.identifier.otherPURE UUID: dc91a4d8-a6fd-4765-90fc-b30e20988d52
dc.identifier.otherScopus: 105031395685
dc.identifier.otherPubMed: 41734274
dc.identifier.urihttp://hdl.handle.net/10362/201411
dc.identifier.urlhttps://www.scopus.com/pages/publications/105031395685
dc.language.isoeng
dc.peerreviewedyes
dc.subjectacute exacerbation
dc.subjectlong-acting injectable
dc.subjectreal-life setting
dc.subjectRisperidone ISM
dc.subjectschizophrenia
dc.subjectPsychiatry and Mental health
dc.subjectBiological Psychiatry
dc.subjectSDG 3 - Good Health and Well-being
dc.titleRisperidone-ISM® effectiveness and tolerability in acute schizophrenia patients hospitalised due to a relapseen
dc.title.subtitleresults from an international, prospective, non-interventional evaluation (RESHAPE study)en
dc.typejournal article
degois.publication.titleWorld Journal Of Biological Psychiatry
dspace.entity.typePublication
rcaap.rightsopenAccess

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