Author(s):
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
Date: 2026
Persistent ID: http://hdl.handle.net/10362/201411
Origin: Repositório Institucional da UNL
Subject(s): acute exacerbation; long-acting injectable; real-life setting; Risperidone ISM; schizophrenia; Psychiatry and Mental health; Biological Psychiatry; SDG 3 - Good Health and Well-being
Description
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.
