Risperidone-ISM® effectiveness and tolerability in acute schizophrenia patients hospitalised due to a relapse: results from an international, prospective, non-interventional evaluation (RESHAPE study).
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Correll Christoph U, Rohner Henrik, Dimalta Savino, Göldner Randi Susanne, Assion Hans-Jörg, Langner-Timm Steffi, Núñez Sande Carmen, Rodriguez-Jimenez Roberto, Bioque Miquel, Gahr Maximilian, Messer Thomas, Falkai Peter, Heres Stephan, Landry Christopher, Schöttle Daniel, Bernardo Miquel, Caballero Montserrat, González-Pinto Ana, Molina Rosa, De Giorgi Serafino, Maina Giuseppe, Vita Antonio, Vieira Coelho María Augusta, Gago Joaquim, Madeira Nuno, Dratcu Luiz, Farooq Saeed, Fernández-Egea Emilio, Pappa Sofia, Anta Carabias Lourdes, Sánchez-García Sheila, Martínez-González Javier
Аннотация
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.