For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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.
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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.
Phone iconCall 0034913756230Email iconEmail Study Center

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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