Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse

This is a non-interventional, multicentre, prospective study conducted in psychiatric inpatient units, and designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia and who are suffering an acute exacerbation, according to routine clinical practice.

The study comprises five visits in total:

Baseline Visit: This visit must be conducted within 48 hours after the first injection of Risperidone ISM. During this visit, the patient must meet all inclusion and exclusion criteria and sign the Informed Consent Form.

Follow-up Visit I: Scheduled approximately 8 ± 2 days after the first injection.

Follow-up Visit II: Scheduled approximately 28 ± 2 days after the first injection.

Discharge Visit: Conducted on the day of discharge, which may vary depending on the individual patient.

Final Visit: Occurs approximately 28 days after the second injection of Risperidone ISM and may be conducted in person or via telephone.

The study will be conducted in five visits: the Baseline Visit is the day on which the patient fulfils the inclusion and exclusion criteria, including signature of the Informed Consent; two follow-up visits will be scheduled after the first injection of Risperidone ISM; in addition, there will be another visit on the day of discharge; and the Final Visit will occur approximately 28 days after the 2nd injection of Risperidone ISM.

The primary objective of the study is to assess, under usual clinical practice, the effectiveness of Risperidone ISM in patients hospitalised due to a schizophrenia relapse.

The secondary objectives include:

Analysis of patterns of use of Risperidone ISM in hospital settings across several European countries.

Characterisation of patient profiles treated with Risperidone ISM in routine clinical practice.

Assessment of social functioning in schizophrenia patients treated with Risperidone ISM.

Evaluation of duration of hospitalisation across participating countries. Measurement of patient-reported treatment satisfaction. Evaluation of safety and tolerability of Risperidone ISM in routine clinical practice.