2026 ECNP Congress

PS03-3248

Functioning and patient-reported medication satisfaction with risperidone-ISM by country in acutely exacerbated schizophrenia: real-world evidence from the RESHAPE study

t.b.a. — T. Messer, A. González-Pinto, S. De Giorgi, L. Dratcu, H. Rohner, R.S. Göldner, J. Martínez González, C.U. Correll · Azienda Sanitaria Locale Foggia, Department of Mental Health, Foggia, Italy

2026 ECNP Congress

Background

Social functioning is considered an integral outcome parameter for evaluating treatment success in schizophrenia [1]. Patient-reported treatment satisfaction is closely associated with medication adherence, relapse risk, and long‑term outcomes [2]. The objective of this analysis was to investigate functioning and patient-reported treatment satisfaction with Risperidone ISM under routine clinical practice conditions in acutely ill patients hospitalized due to schizophrenia relapse across several European countries participating in the RESHAPE study [3].

Methods

RESHAPE is a multicenter, non-interventional study conducted in adult patients with schizophrenia hospitalized due to acute exacerbation and treated with Risperidone ISM as part of routine clinical practice (NCT05480046). A pre-planned subanalysis of the RESHAPE study by country was conducted. The functioning and patient satisfaction with treatment were evaluated using the Personal and Social Performance (PSP) scale and Medication Satisfaction Questionnaire (MSQ) at Baseline Visit (BV, first Risperidone ISM injection), Day 28 after the first injection (FU2) and at final visit (FV) 28 days after the second injection (Day 56).

Changes from baseline (CFB) to endpoint in PSP and MSQ were assessed using Wilcoxon Signed Rank for paired data. Statistical tests were two-tailed with alpha=0.05.

Results

275 participants were enrolled in the RESHAPE study. Mean (SD) PSP scores significantly increased from BV to both assessment timepoints (1 patient from UK not included):

Country (N) Parameter BV [Mean (SD)] FU2 (Day 28) [Mean (SD)] FV (Day 56) [Mean (SD)]
Germany (118) PSP score 35.4 (17.4) 50.1 (19.4) 53.0 (19.2)
CFB in PSP score - 13.4 (15.2) p<0.0001 17.38 (14.7) p<0.0001
Spain (93) PSP score 37.9 (19.7) 62.0 (16.2) 65.7 (16.6)
CFB in PSP score - 25.1 (20.0) p<0.0001 27.6 (19.9) p<0.0001
Italy (47) PSP score 41.7 (17.3) 54.5 (19.0) 59.9 (16.5)
CFB in PSP score - 12.0 (12.4) p<0.0001 17.5 (13.5) p<0.0001
Portugal (16) PSP score 37.7 (18.4) 61.7 (17.7) 70.2 (14.2)
CFB in PSP score - 20.40 (17.1) p=0.004 23.2 (14.9) p=0.01

After the second injection of risperidone ISM, rated compared to previous antipsychotic treatment, the proportion of patients reporting satisfaction (‘extremely’, ‘very’, or ‘somewhat satisfied’) in the MSQ increased across all countries, rising from 53.4% to 84.5%, 49.5% to 74.3%, 45.2% to 76.3%, and 31.3% to 66.7% in Germany, Spain, Italy and Portugal, respectively. Conversely, the proportion of patients reporting dissatisfaction (‘somewhat’, ‘very’, or ‘extremely dissatisfied’) decreased markedly, from 28.8% to 7.1%, 33.0% to 19.7%, 28.6% to 10.5%, and 43.8% to 11.1% in Germany, Spain, Italy and Portugal, respectively.

Discussion

In this real-world study, Risperidone ISM provided a rapid and significant improvement in personal and social functioning from the first injection until the end of week 8 across all participating countries. In addition, treatment with Risperidone ISM was associated with a substantial increase in patient‑reported satisfaction and a marked reduction in dissatisfaction with antipsychotic treatment, supporting its acceptability in routine clinical practice among acutely exacerbated patients with schizophrenia.

References

References:

  1. Brissos, S., Molodynski, A., Dias, V. V., & Figueira, M. L. (2011). The importance of measuring psychosocial functioning in schizophrenia. Annals of general psychiatry, 10(1), 18.
  2. Awad, A. G., & Voruganti, L. N. (2013). The impact of newer atypical antipsychotics on patient-reported outcomes in schizophrenia. CNS drugs, 27(8), 625-636.
  3. Correll, C. U., Rohner, H., Dimalta, S., Göldner, R. S., Assion, H. J., Langner-Timm, S., … & Martínez-González, J. (2026). 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, 27(4), 361-378.