Clinical Efficacy and Suicidality Impact of Risperidone ISM in Acute Psychosis: A Real-world Observational Study
Alessandro Carano, Alexsander Di Cintio, Matteo Lupi, Melanie Di Salvatore, Domenico De Berardis, Giovanni MartinottiBackground/Objectives:
Acute psychotic episodes in schizophrenia represent a critical stage in clinical management, often characterized by significant ideobehavioral disorganization, poor therapeutic adherence, and increased suicide risk. Currently, a broad consensus of clinicians and experts consider long-acting injectables (LAIs) a valuable and indispensable tool in clinical practice, also used as a first-line treatment in the acute phases of the illness. Risperidone ISM (in situ microparticles), reaches effective therapeutic concentrations within the first 24 hours of administration, without any oral supplementation, thus representing a potentially useful option, particularly during the hospitalization phase.
Methods:
A prospective, single-center observational study was conducted at the Psychiatric Diagnosis and Treatment Service (SPDC) of the AST of Ascoli Piceno (Marche Region; Italy), between November 2024 and November 2025. Patients with a diagnosis of acute psychosis who were administered risperidone ISM (75 to 100 mg) during their hospitalization were included. Anamnestic data and psychometric assessments were collected at the first administration of risperidone ISM (T0), one week after administration (T1), and 30 days after the first administration (T2).
Results:
A total of 53 patients were selected (mean age 37.8; 60% male). PANSS score decreased by 29% between T0 and T2; the subscales showed reductions of 31.5% (positive symptoms), 25.2% (negative symptoms), and 30.4% (general symptoms). Perceived clinical severity (CGI-S) decreased by 40%. SAS decreased by 33%, with a decrease in high-risk patients from 28% to 4%.
Conclusions:
Risperidone ISM produced rapid and significant clinical stabilization in patients with acute psychosis admitted to SPDC, with a measurable reduction in psychopathology and suicidality.