2026 ECNP Congress
PS03-3246Effectiveness of Risperidone ISM in acutely exacerbated schizophrenia in different countries: real world evidence from the RESHAPE study
Background
Schizophrenia is a long‑term mental illness marked by psychotic episodes, functional decline, and frequent relapses, often linked to poor treatment adherence. In a phase-3 study, LAI Risperidone-ISM demonstrated a rapid onset and sustained efficacy in acutely ill patients [1]. This analysis assessed the effectiveness of Risperidone-ISM in routine clinical practice among hospitalized patients for schizophrenia relapse across several European countries participating in the RESHAPE study [2].
Methods
RESHAPE is a multicenter, non-interventional study conducted in adult patients with schizophrenia hospitalized with acute exacerbation and treated with Risperidone-ISM as part of routine clinical practice (NCT05480046). A pre-planned subanalysis of treatment effectiveness by country was conducted. Effectiveness was evaluated using the Clinical Global Impression-Severity (CGI-S) and 6-item Positive and negative Syndrome Scale (PANSS-6) at baseline visit (BV, first Risperidone-ISM injection), Day 8 (FU1), Day 28 after the first injection (FU2) and a final visit (FV) 28 days after the second injection (Day 56). Changes from baseline (CFB) to endpoint in CGI-S and PANSS-6 scores were assessed using the Wilcoxon-signed rank test and the Student t-test, respectively. All statistical tests were two-tailed with alpha=0.05.
Results
275 participants were enrolled into RESHAPE. Mean (SD) CFB in CGI-S and PANSS-6 scores were statistically significant at all study visits, starting as early as 8 days after the first injection of Risperidone-ISM (1 patient from UK not included):
| Country (N) | Parameter, Mean (SD) | BV | FU1 (Day 8) | FU2 (Day 28) | FV (Day 56) |
|---|---|---|---|---|---|
| Germany - 118 | CGI-S score | 4.9 (0.9) | 4.5 (0.9) | 4.0 (1.0) | 3.8 (1.1) |
| CFB in CGI-S | - | -0.45 (0.74) | -0.85 (0.97) | -1.07 (1.15) | |
| p< 0.0001 | p< 0.0001 | p< 0.0001 | |||
| PANSS-6 score | 22.40 (5.77) | 19.51 (5.34) | 17.40 (5.27) | 16.49 (5.42) | |
| CFB in PANSS-6 | - | -3.01 (4.09) | -5.06 (5.22) | -5.96 (5.31) | |
| p< 0.0001 | p< 0.0001 | p< 0.0001 | |||
| Spain - 93 | CGI-S score | 4.7 (1.1) | 3.6 (1.1) | 2.8 (1.0) | 2.6 (1.1) |
| CFB in CGI-S | - | -1.13 (0.95) | -1.90 (1.16) | -2.11 (1.36) | |
| p< 0.0001 | p< 0.0001 | p< 0.0001 | |||
| PANSS-6 score | 22.42 (6.18) | 17.54 (5.44) | 13.56 (4.91) | 12.26 (4.45) | |
| CFB in PANSS-6 | - | -5.37 (4.67) | -9.21 (5.99) | -10.39 (6.31) | |
| p< 0.0001 | p< 0.0001 | p< 0.0001 | |||
| Italy - 47 | CGI-S score | 4.2 (1.0) | 3.6 (1.1) | 3.32 (1.0) | 3.1 (1.0) |
| CFB in CGI-S | - | -0.54 (0.69) | -0.85 (0.82) | -0.92 (0.82) | |
| p< 0.0001 | p< 0.0001 | p< 0.0001 | |||
| PANSS-6 score | 18.13 (6.08) | 14.91 (5.94) | 13.32 (5.46) | 11.68 (5.41) | |
| CFB in PANSS-6 | - | -3.07 (2.85) | -4.93 (3.65) | -5.92 (4.31) | |
| p< 0.0001 | p< 0.0001 | p< 0.0001 | |||
| Portugal - 16 | CGI-S score | 5.1 (1.4) | 3.8 (1.2) | 3.5 (1.2) | 3.2 (1.1) |
| CFB in PSP | - | -1.25 (1.00) | -1.50 (1.45) | -1.89 (0.78) | |
| p= 0.0005 | p= 0.0020 | p< 0.0001 | |||
| PANSS-6 score | 26.25 (6.99) | 20.19 (5.48) | 16.64 (5.56) | 17.33 (7.47) | |
| CFB in PANSS-6 score | - | -6.06 (4.65) | -9.86 (8.04) | -8.33 (5.15) | |
| p= 0.0001 | p= 0.0005 | p= 0.0013 |
Discussion
In this real-world study, Risperidone-ISM showed rapid and sustained effectiveness, with significant symptom improvement observed as early as day 8 after the first injection. Improvements were consistent across participating countries, highlighting Risperidone-ISM as a reliable treatment option for schizophrenia in routine clinical practice.
References
- Correll CU, Litman RE, Filts Y, Llaudó J, Naber D, Torres F, Martínez J. Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation. NPJ Schizophr. 2020;6(1):37.
- Correll CU, Rohner H, Dimalta S, Göldner RS, Assion HJ, Langner-Timm S, Núñez Sande C, Rodriguez-Jimenez R, Bioque M, Gahr M, Messer T, Falkai P, Heres S, Landry C, Schöttle D, Bernardo M, Caballero M, González-Pinto A, Molina R, De Giorgi S, Maina G, Vita A, Vieira Coelho MA, Gago J, Madeira N, Dratcu L, Farooq S, Fernández-Egea E, Pappa S, Anta Carabias L, Sánchez-García S, Martínez-González J. Risperidone-ISM® effectiveness and tolerability in acute schizophrenia patients hospitalised due to a relapse: results from an international, prospective, non-interventional evaluation (RESHAPE study). World J Biol Psychiatry. 2026;27(4):361-378.