2026 ECNP Congress

PS01-1195

Risperidone-ISM in early-phase schizophrenia: effectiveness and functioning in acutely exacerbated participants from the RESHAPE study

Henrik Rohner — D. Schöttle, R. Rodríguez Jiménez, S. Dimalta, N. Madeira, E. Fernandez Egea, R.S. Göldner, N. Bassetti, C. Correll · University Hospital of Bonn, Department of Psychiatry and Psychotherapy, Bonn, Germany

2026 ECNP Congress

Background

Schizophrenia is a leading cause of disability [1]. Early intervention can improve long-term outcomes by reducing symptom severity and relapse rates [2]. However, non-adherence and partial remission during acute exacerbations remain common [3]. Patients in an early-phase of the disorder may benefit from long-acting injectable antipsychotics (LAIs), which reduce relapses, rehospitalization, and functional impairment [4]. The LAI Risperidone-ISM® provides rapid onset of therapeutic effect without oral supplementation or loading doses, offering an advantage in acutely exacerbated patients [5]. The RESHAPE study evaluated the real-world effectiveness and tolerability of Risperidone-ISM® [6].

Methods

RESHAPE is a multicenter, non-interventional study conducted in adult patients with schizophrenia hospitalized due to acute exacerbation and treated with Risperidone-ISM® under routine clinical practice (NCT05480046). A pre-planned subanalysis of the RESHAPE study was conducted in participants with <5 years since schizophrenia diagnosis. The effectiveness of Risperidone-ISM® was evaluated by 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) and across the follow-up scheduled visits: Day 8 (FU1), Day 28 after the first injection (FU2) and a final visit (FV) 28 days after the second injection. Functioning was also assessed by using the Personal and Social Performance Scale (PSP) at BV, FU2 and FV. Changes from baseline (CFB) to endpoint in CGI-S scores were assessed using the Wilcoxon-signed rank test. CFB in PANSS-6 and PSP were also assessed, using Student T-test for paired data and Wilcoxon-signed rank test, respectively. All statistical tests were two-tailed with alpha=0.05.

Results

Of the 275 participants enrolled in the RESHAPE study, 106 (38.5%) were classified as having early-phase schizophrenia and included in the subanalysis.

Parameter, Mean (SD) BV FU1 (Day 8) FU2 (Day 28) FV (Day 56)
CGI-S score 4.6 (1.1) 3.9 (1.1) 3.3 (1.2) 3.0 (1.3)
CFB in CGI-S score - -0.8 (0.9) -1.3 (1.2) -1.6 (1.4)
PANSS-6 score 21.0 (6.5) 17.0 (5.8) 14.2 (5.1) 13.1 (5.3)
CFB in PANSS-6 score - -4.5 (4.3) -7.3 (6.2) -8.1 (6.3)
PSP score 39.5 (18.8) - 58.7 (19.0) 64.3 (16.5)
CFB in PSP score - - 19.0 (18.6) 25.2 (17.8)

The mean (SD) CGI-S and PANSS-6 score decreased from baseline to all post-baseline study visits with a statistically significant (p<0.0001) and clinically meaningful magnitude of CFB, starting as early as 8 days after the first injection of Risperidone-ISM® (Table 1).

The mean PSP score increased from BV to both post-baseline assessment timepoints. Moreover, a statistically significant (p<0.0001) improvement in functioning of 19 points was observed 28 days after the first injection, which further increased up to 25.2 points (p<0.0001) at the FV (Table 1).

Conclusions

Risperidone-ISM® demonstrated rapid and sustained effectiveness in significantly reducing symptoms and improving personal and social functioning in patients with early-phase schizophrenia who were hospitalized due to a relapse and received Risperidone-ISM® as part of usual clinical care, showing also statistically significant improvements in global illness severity and total PANSS-6 scores, representing both positive and negative symptoms as early as day 8 after the first injection.

References

References:

  1. Charlson, F. J., Ferrari, A. J., Santomauro, D. F., Diminic, S., Stockings, E., Scott, J. G., McGrath, J. J., & Whiteford, H. A., 2018. Global Epidemiology and Burden of Schizophrenia: Findings From the Global Burden of Disease Study 2016. Schizophrenia bulletin, 44(6), 1195–1203.
  2. Salazar de Pablo, G., Guinart, D., Armendariz, A., Aymerich, C., Catalan, A., Alameda, L., Correll, C. U., 2024. Duration of untreated psychosis and outcomes in first-episode psychosis: systematic review and meta-analysis of early detection and intervention strategies. Schizophrenia Bulletin, 50(4), 771-783.
  3. Takeuchi, H., Siu, C., Remington, G., Fervaha, G., Zipursky, R. B., Foussias, G., & Agid, O., 2019. Does relapse contribute to treatment resistance? Antipsychotic response in first-vs. second-episode schizophrenia. Neuropsychopharmacology, 44(6), 1036-1042.
  4. Arango, C., Fagiolini, A., Gorwood, P., Kane, J. M., Diaz-Mendoza, S., Sahota, N., & Correll, C. U., 2023. Delphi panel to obtain clinical consensus about using long-acting injectable antipsychotics to treat first-episode and early-phase schizophrenia: treatment goals and approaches to functional recovery. BMC psychiatry, 23(1), 453.
  5. Messer, T., Bernardo, M., Anta, L., Martínez-González, J., 2024. Risperidone-ISM®: Review and update of its usefulness in all phases of schizophrenia. Therapeutic Advances in Psychopharmacology, 14, 1-21.
  6. Correll, C. U., Rohner, H., Dimalta, S., Göldner, R. S., Assion, H. J., Langner-Timm, S., et al., 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). The World Journal of Biological Psychiatry, 27:4, 361-378.