NCT05480046Completed
Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse
Risperidone ISM® Effectiveness in Schizophrenia Patients Hospitalised Due to A Relapse: a Prospective Non-interventional Evaluation (RESHAPE Study)
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 275 (actual)
- First submitted
- 20 Jul 2022
- Start date
- 18 Oct 2022
- Primary completion date
- 13 Mar 2025
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Diseases
- Schizophrenia
- NCT number
- NCT05480046
What you commit to
- Study type: Observational
- Participants enrolled: 275
- From 18 Oct 2022 to the primary completion date, 13 Mar 2025
- 77 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently on antipsychotic treatment with clozapine or any long-acting injectable antipsychotic.
Other illness
- Patient with a diagnosis of schizoaffective disorder, bipolar disorder mental retardation, or other cognitive and neurodevelopmental disorders.
- Patient with a serious and unstable medical condition, forensic patients, or patients with any contraindication mentioned in the SmPC of Risperidone ISM.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (77)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational site number DE-06 Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Investigational site number DE-14 Coordinator of this site? Confirm its status | Ansbach | Germany | Unknown status |
| Investigational site number DE-23 Coordinator of this site? Confirm its status | Bayreuth | Germany | Unknown status |
| Investigational site number DE-10 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Investigational site number DE-12 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Investigational site number DE-15 Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Investigational site number DE-07 Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Investigational site number DE-16 Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Investigational site number DE-02 Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Investigational site number DE-03 Coordinator of this site? Confirm its status | Dortmund | Germany | Unknown status |
| Investigational site number DE-25 Coordinator of this site? Confirm its status | Eberswalde | Germany | Unknown status |
| Investigational Site number DE-01 Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Investigational site number DE-08 Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| Investigational site number DE-22 Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Investigational site number DE-20 Coordinator of this site? Confirm its status | Hemer | Germany | Unknown status |
| Investigational site number DE-19 Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Investigational site number DE-05 Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Investigational site number DE-09 Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Investigational site number DE-04 Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Investigational site number DE-24 Coordinator of this site? Confirm its status | Neustadt | Germany | Unknown status |
| Investigational site number DE-13 Coordinator of this site? Confirm its status | Werneck | Germany | Unknown status |
| Investigational site number ES-81 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Investigational site number ES-45 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Investigational site number ES-03 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Investigational site number ES-16 Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
| Investigational site number ES-23 Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Investigational site number ES-11 Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Investigational site number ES-59 Coordinator of this site? Confirm its status | Huesca | Spain | Unknown status |
| Investigational site number ES-21 Coordinator of this site? Confirm its status | Jaén | Spain | Unknown status |
| Investigational site number ES-70 Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| Investigational site number ES-60 Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Investigational site number ES-72 Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Investigational site number ES-49 Coordinator of this site? Confirm its status | Lleida | Spain | Unknown status |
| Investigational site number ES-51 Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Investigational site number ES-66 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Investigational site number ES-24 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Investigational site number ES-19 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Investigational site number ES-63 Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Investigational site number ES-04 Coordinator of this site? Confirm its status | Manacor | Spain | Unknown status |
| Investigational site number ES-73 Coordinator of this site? Confirm its status | Manresa | Spain | Unknown status |
| Investigational site number ES-65 Coordinator of this site? Confirm its status | Mataró | Spain | Unknown status |
| Investigational site number ES-14 Coordinator of this site? Confirm its status | Móstoles | Spain | Unknown status |
| Investigational site number ES-18 Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Investigational site number ES-52 Coordinator of this site? Confirm its status | Ourense | Spain | Unknown status |
| Investigational site number ES-62 Coordinator of this site? Confirm its status | Ponferrada | Spain | Unknown status |
| Investigational site number ES-69 Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Investigational site number ES-02 Coordinator of this site? Confirm its status | Talavera de la Reina | Spain | Unknown status |
| Investigational site number ES-42 Coordinator of this site? Confirm its status | Torrejón | Spain | Unknown status |
| Investigational site number ES-76 Coordinator of this site? Confirm its status | Úbeda | Spain | Unknown status |
| Investigational site number ES-31 Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Investigational site number ES-40 Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Unknown status |
| Investigational site number GB-08 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Investigational site number IT-32 Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Investigational site number IT-19 Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| Investigational site number IT-24 Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Investigational site number IT-65 Coordinator of this site? Confirm its status | Brindisi | Italy | Unknown status |
| Investigational site number IT-20 Coordinator of this site? Confirm its status | Crema | Italy | Unknown status |
| Investigational site number IT-41 Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Investigational site number IT-03 Coordinator of this site? Confirm its status | Legnano | Italy | Unknown status |
| Investigational site number IT-47 Coordinator of this site? Confirm its status | Manfredonia | Italy | Unknown status |
| Investigational site number IT-06 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Investigational site number IT-42 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Investigational site number IT-18 Coordinator of this site? Confirm its status | Montichiari | Italy | Unknown status |
| Investigational site number IT-113 Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Investigational site number IT-44 Coordinator of this site? Confirm its status | Putignano | Italy | Unknown status |
| Investigational site number IT-97 Coordinator of this site? Confirm its status | Sant'Agata di Militello | Italy | Unknown status |
| Investigational site number IT-90 Coordinator of this site? Confirm its status | Vimercate | Italy | Unknown status |
| Investigational site number PT-25 Coordinator of this site? Confirm its status | Beja | Portugal | Unknown status |
| Investigational site number PT-24 Coordinator of this site? Confirm its status | Braga | Portugal | Unknown status |
| Investigational site number PT-01 Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Investigational site number PT-36 Coordinator of this site? Confirm its status | Funchal | Portugal | Unknown status |
| Investigational site number PT-33 Coordinator of this site? Confirm its status | Funchal | Portugal | Unknown status |
| Investigational site number PT-20 Coordinator of this site? Confirm its status | Guarda | Portugal | Unknown status |
| Investigational site number PT-32 Coordinator of this site? Confirm its status | Portimão | Portugal | Unknown status |
| Investigational site number PT-13 Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Investigational site number PT-11 Coordinator of this site? Confirm its status | Santo Tirso | Portugal | Unknown status |
| Investigational site number PT-27 Coordinator of this site? Confirm its status | Tomar | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.