RESHAPE
Research type
Research Study
Full title
Risperidone ISM effectiveness in Schizophrenia patients hospitalised due to relapse: a prospective non-interventional study evaluation (RESHAPE study)
IRAS ID
316656
Contact name
Luiz Dratcu
Contact email
Sponsor organisation
LABORATORIOS FARMACÉUTICOS ROVI, S.A.
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Risperidone ISM, obtained marketing authorisation in February in the EU and in March 2022 in the UK after completing a full program of clinical trials.
The results from the randomized controlled trials have clearly demonstrated the efficacy and safety of Risperidone ISM under experimental conditions, but it is also important to study in the real world the profiles of adult patients who are hospitalised due to a schizophrenia relapse and subsequently treated with Risperidone ISM.
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 a relapse, 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.
Data will be collected in the study visits and will be collected from the source documents for each patient in the study, consisting of medical records containing demographic data, medical, treatment and diagnostic documentation and directly from the patients. Additionally, PSP (Positive and Social Performance), CGI-S (The Clinical Global Impressions Scale) and PANSS-6 (Positive and Negative Syndrome) scales will be completed by treating physicians, while a short questionnaire will be completed by patients.
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 from 244 sites across participating countries.
REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0123
Date of REC Opinion
23 Mar 2023
REC opinion
Further Information Favourable Opinion