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

Schizophrenia Clinical Trial

Official title:
Risperidone ISM® Effectiveness in Schizophrenia Patients Hospitalised Due to A Relapse: a Prospective Non-interventional Evaluation (RESHAPE Study)

Clinical Trial Summary

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.

Clinical Trial Description

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 will be enrolled in the sites from the participating countries. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05480046
Study type Observational
Source Rovi Pharmaceuticals Laboratories
Contact Javier Martínez
Phone 0034913756230
Email departamento.medico@rovi.es
Status Recruiting
Phase
Start date October 18, 2022
Completion date June 2024
View Details
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