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

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

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 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.

Approximately 1,200 adults' patients were calculated to be enrolled in the sites from the participating countries.

The initial sample size estimation relied on an extremely small effect size that would be very unlikely given the results on a previous clinical trial with Risperidone ISM. After the examination of preliminary trial data and considering that the recruitment period was going to be longer than expected (mostly related to administrative issues for activating sites), the Sponsor has decided to re-evaluate the sample size required for the study. For this new estimation, the objective was to calculate the sample size that would allow to perform the analyses of the primary effectiveness variables not only in the total study population, but also in the subgroups who were pre-specified in the study protocol. Accordingly, the estimation was adjusted for each of the subgroups estimated share of the total study sample, and then accounted for the expected loss of patients, that was adjusted upwards to 35%. After that, the new sample size was set at approximately 272 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 years or older at the time of hospitalisation.
2. Patient with diagnosis of schizophrenia, as per clinical judgment.
3. Patient admitted to a psychiatric inpatient unit due to an acute exacerbation.
4. Patient has started treatment with Risperidone ISM within the previous 48 hours, according to the current Summary of Product Characteristics (SmPC).
5. Patient or their legal representative provides written informed consent to participate in the study.

Exclusion Criteria:

1. Patient with a diagnosis of schizoaffective disorder, bipolar disorder mental retardation, or other cognitive and neurodevelopmental disorders.
2. Patient with substance-induced psychosis or psychosis during intoxication (patients with comorbid substance abuse/dependence are allowed).
3. Patient unable to answer the study questionnaires.
4. Patient who is currently participating in another clinical study.
5. Patient pregnant or breast-feeding.
6. Patient with a serious and unstable medical condition, forensic patients, or patients with any contraindication mentioned in the SmPC of Risperidone ISM.
7. Patients currently on antipsychotic treatment with clozapine or any long-acting injectable antipsychotic.