Risperidone-ISM^® effectiveness and tolerability in acute schizophrenia patients hospitalised due to a relapse: results from an international, prospective, non-interventional evaluation (RESHAPE study)

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.