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

NCT05480046 | Completed

• 1 other identifier: ROV-RISP-2021-01
• Study Type: observational
• Target: 275
• Locations: 5 countries
• Sites: 77

Brief 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.

Conditions

Schizophrenia

Keywords

Risperidone; Schizophrenia; Long-acting injectable

Outcome Measures

Primary Outcomes (2)

• Clinical Global Impression-Severity of Illness scale (CGI-S): change from baseline to Day 56.

  The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome.

  Baseline and Day 56 (or the last post-baseline assessment)

• Positive and Negative Syndrome Scale (PANSS-6): change from baseline to Day 56.

  The six-item version of the Positive and Negative Syndrome Scale (PANSS-6) is a 6-item scale derived from the full 30-item PANSS which evaluate: Delusions, Conceptual disorganization, Hallucinations, Blunted Affect, Social withdrawal and Lack of spontaneity and flow of conversation Safety and tolerability.

  Baseline and Day 56 (or the last post-baseline assessment)

Secondary Outcomes (4)

• Personal and Social Performance (PSP) scale

  Baseline and Day 56 (or the last post-baseline assessment)

• Medication Satisfaction Questionnaire (MSQ)

  Day 56 (or the last post-baseline assessment)

• Duration of hospitalisation

  Baseline and Day 56 (or the last post-baseline assessment)

• Adverse drug reactions (ADR)

  Up to Day 56 (or the last post-baseline assessment)

Interventions

Risperidone ISM DRUG

Risperidone ISM is administered every 4 weeks

Also known as: OKEDI®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 diagnosed with schizophrenia who are admitted to a psychiatric unit due to a relapse and initiate treatment with Risperidone ISM (OKEDI®), according to the therapeutic indication of the marketing authorization ("Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone") under routine clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (77)

Investigational site number DE-06

Aachen, Germany

Location

Investigational site number DE-14

Ansbach, Germany

Location

Investigational site number DE-23

Bayreuth, Germany

Location

Investigational site number DE-10

Berlin, Germany

Location

Investigational site number DE-12

Berlin, Germany

Location

Investigational site number DE-15

Berlin, Germany

Location

Investigational site number DE-07

Bonn, Germany

Location

Investigational site number DE-16

Bonn, Germany

Location

Investigational site number DE-02

Chemnitz, Germany

Location

Investigational site number DE-03

Dortmund, Germany

Location

Investigational site number DE-25

Eberswalde, Germany

Location

Investigational Site number DE-01

Essen, Germany

Location

Investigational site number DE-08

Greifswald, Germany

Location

Investigational site number DE-22

Hamburg, Germany

Location

Investigational site number DE-20

Hemer, Germany

Location

Investigational site number DE-19

Leipzig, Germany

Location

Investigational site number DE-05

Mannheim, Germany

Location

Investigational site number DE-04

Munich, Germany

Location

Investigational site number DE-09

München, Germany

Location

Investigational site number DE-24

Neustadt, Germany

Location

Investigational site number DE-13

Werneck, Germany

Location

Investigational site number IT-32

Ancona, Italy

Location

Investigational site number IT-19

Bolzano, Italy

Location

Investigational site number IT-24

Brescia, Italy

Location

Investigational site number IT-65

Brindisi, Italy

Location

Investigational site number IT-20

Crema, Italy

Location

Investigational site number IT-41

Foggia, Italy

Location

Investigational site number IT-03

Legnano, Italy

Location

Investigational site number IT-47

Manfredonia, Italy

Location

Investigational site number IT-06

Milan, Italy

Location

Investigational site number IT-42

Milan, Italy

Location

Investigational site number IT-18

Montichiari, Italy

Location

Investigational site number IT-113

Palermo, Italy

Location

Investigational site number IT-44

Putignano, Italy

Location

Investigational site number IT-97

Sant'Agata di Militello, Italy

Location

Investigational site number IT-90

Vimercate, Italy

Location

Investigational site number PT-25

Beja, Portugal

Location

Investigational site number PT-24

Braga, Portugal

Location

Investigational site number PT-01

Coimbra, Portugal

Location

Investigational site number PT-33

Funchal, Portugal

Location

Investigational site number PT-36

Funchal, Portugal

Location

Investigational site number PT-20

Guarda, Portugal

Location

Investigational site number PT-32

Portimão, Portugal

Location

Investigational site number PT-13

Porto, Portugal

Location

Investigational site number PT-11

Santo Tirso, Portugal

Location

Investigational site number PT-27

Tomar, Portugal

Location

Investigational site number ES-03

Barcelona, Spain

Location

Investigational site number ES-45

Barcelona, Spain

Location

Investigational site number ES-81

Barcelona, Spain

Location

Investigational site number ES-16

Burgos, Spain

Location

Investigational site number ES-23

Córdoba, Spain

Location

Investigational site number ES-11

Granada, Spain

Location

Investigational site number ES-59

Huesca, Spain

Location

Investigational site number ES-21

Jaén, Spain

Location

Investigational site number ES-70

Jerez de la Frontera, Spain

Location

Investigational site number ES-72

L'Hospitalet de Llobregat, Spain

Location

Investigational site number ES-60

Las Palmas de Gran Canaria, Spain

Location

Investigational site number ES-49

Lleida, Spain

Location

Investigational site number ES-51

Lugo, Spain

Location

Investigational site number ES-19

Madrid, Spain

Location

Investigational site number ES-24

Madrid, Spain

Location

Investigational site number ES-66

Madrid, Spain

Location

Investigational site number ES-63

Majadahonda, Spain

Location

Investigational site number ES-04

Manacor, Spain

Location

Investigational site number ES-73

Manresa, Spain

Location

Investigational site number ES-65

Mataró, Spain

Location

Investigational site number ES-14

Móstoles, Spain

Location

Investigational site number ES-18

Murcia, Spain

Location

Investigational site number ES-52

Ourense, Spain

Location

Investigational site number ES-62

Ponferrada, Spain

Location

Investigational site number ES-69

Santander, Spain

Location

Investigational site number ES-02

Talavera de la Reina, Spain

Location

Investigational site number ES-42

Torrejón, Spain

Location

Investigational site number ES-76

Úbeda, Spain

Location

Investigational site number ES-31

Vigo, Spain

Location

Investigational site number ES-40

Vitoria-Gasteiz, Spain

Location

Investigational site number GB-08

London, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Christoph U Correll

  Charite University, Berlin, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 29, 2022
• Study Start: October 18, 2022
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

DE (21); ES (30); GB (1); PT (10); IT (15)