Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Patient aged 18 years or older at the time of hospitalisation.
- Patient with diagnosis of schizophrenia, as per clinical judgment.
- Patient admitted to a psychiatric inpatient unit due to an acute exacerbation.
- Patient has started treatment with Risperidone ISM within the previous 48 hours, according to the current Summary of Product Characteristics (SmPC).
- Patient or their legal representative provides written informed consent to participate in the study.
EXCLUSION CRITERIA
Exclusion Criteria:
- Patient with a diagnosis of schizoaffective disorder, bipolar disorder mental retardation, or other cognitive and neurodevelopmental disorders.
- Patient with substance-induced psychosis or psychosis during intoxication (patients with comorbid substance abuse/dependence are allowed).
- Patient unable to answer the study questionnaires.
- Patient who is currently participating in another clinical study.
- Patient pregnant or breast-feeding.
- Patient with a serious and unstable medical condition, forensic patients, or patients with any contraindication mentioned in the SmPC of Risperidone ISM.
- Patients currently on antipsychotic treatment with clozapine or any long-acting injectable antipsychotic.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Schizophrenia
Age
18+
Participants Needed
1200
Est. Completion Date
Jun 30, 2024
Treatment Type
OBSERVATIONAL
Sponsor
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov NCT Identifier
NCT05480046
Study Number
ROV-RISP-2021-01
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