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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
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

Full criteria on ClinicalTrials.gov

Sites (77)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Investigational site number DE-06
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AachenGermanyUnknown status
Investigational site number DE-14
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AnsbachGermanyUnknown status
Investigational site number DE-23
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BayreuthGermanyUnknown status
Investigational site number DE-10
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BerlinGermanyUnknown status
Investigational site number DE-12
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BerlinGermanyUnknown status
Investigational site number DE-15
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BerlinGermanyUnknown status
Investigational site number DE-07
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BonnGermanyUnknown status
Investigational site number DE-16
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BonnGermanyUnknown status
Investigational site number DE-02
Coordinator of this site? Confirm its status
ChemnitzGermanyUnknown status
Investigational site number DE-03
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DortmundGermanyUnknown status
Investigational site number DE-25
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EberswaldeGermanyUnknown status
Investigational Site number DE-01
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EssenGermanyUnknown status
Investigational site number DE-08
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GreifswaldGermanyUnknown status
Investigational site number DE-22
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HamburgGermanyUnknown status
Investigational site number DE-20
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HemerGermanyUnknown status
Investigational site number DE-19
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LeipzigGermanyUnknown status
Investigational site number DE-05
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MannheimGermanyUnknown status
Investigational site number DE-09
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MünchenGermanyUnknown status
Investigational site number DE-04
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MunichGermanyUnknown status
Investigational site number DE-24
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NeustadtGermanyUnknown status
Investigational site number DE-13
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WerneckGermanyUnknown status
Investigational site number ES-81
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BarcelonaSpainUnknown status
Investigational site number ES-45
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BarcelonaSpainUnknown status
Investigational site number ES-03
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BarcelonaSpainUnknown status
Investigational site number ES-16
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BurgosSpainUnknown status
Investigational site number ES-23
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CórdobaSpainUnknown status
Investigational site number ES-11
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GranadaSpainUnknown status
Investigational site number ES-59
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HuescaSpainUnknown status
Investigational site number ES-21
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JaénSpainUnknown status
Investigational site number ES-70
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Jerez de la FronteraSpainUnknown status
Investigational site number ES-60
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Las Palmas de Gran CanariaSpainUnknown status
Investigational site number ES-72
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L'Hospitalet de LlobregatSpainUnknown status
Investigational site number ES-49
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LleidaSpainUnknown status
Investigational site number ES-51
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LugoSpainUnknown status
Investigational site number ES-66
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MadridSpainUnknown status
Investigational site number ES-24
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MadridSpainUnknown status
Investigational site number ES-19
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MadridSpainUnknown status
Investigational site number ES-63
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MajadahondaSpainUnknown status
Investigational site number ES-04
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ManacorSpainUnknown status
Investigational site number ES-73
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ManresaSpainUnknown status
Investigational site number ES-65
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MataróSpainUnknown status
Investigational site number ES-14
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MóstolesSpainUnknown status
Investigational site number ES-18
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MurciaSpainUnknown status
Investigational site number ES-52
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OurenseSpainUnknown status
Investigational site number ES-62
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PonferradaSpainUnknown status
Investigational site number ES-69
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SantanderSpainUnknown status
Investigational site number ES-02
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Talavera de la ReinaSpainUnknown status
Investigational site number ES-42
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TorrejónSpainUnknown status
Investigational site number ES-76
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ÚbedaSpainUnknown status
Investigational site number ES-31
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VigoSpainUnknown status
Investigational site number ES-40
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Vitoria-GasteizSpainUnknown status
Investigational site number GB-08
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LondonUnited KingdomUnknown status
Investigational site number IT-32
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AnconaItalyUnknown status
Investigational site number IT-19
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BolzanoItalyUnknown status
Investigational site number IT-24
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BresciaItalyUnknown status
Investigational site number IT-65
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BrindisiItalyUnknown status
Investigational site number IT-20
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CremaItalyUnknown status
Investigational site number IT-41
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FoggiaItalyUnknown status
Investigational site number IT-03
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LegnanoItalyUnknown status
Investigational site number IT-47
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ManfredoniaItalyUnknown status
Investigational site number IT-06
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MilanItalyUnknown status
Investigational site number IT-42
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MilanItalyUnknown status
Investigational site number IT-18
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MontichiariItalyUnknown status
Investigational site number IT-113
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PalermoItalyUnknown status
Investigational site number IT-44
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PutignanoItalyUnknown status
Investigational site number IT-97
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Sant'Agata di MilitelloItalyUnknown status
Investigational site number IT-90
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VimercateItalyUnknown status
Investigational site number PT-25
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BejaPortugalUnknown status
Investigational site number PT-24
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BragaPortugalUnknown status
Investigational site number PT-01
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CoimbraPortugalUnknown status
Investigational site number PT-36
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FunchalPortugalUnknown status
Investigational site number PT-33
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FunchalPortugalUnknown status
Investigational site number PT-20
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GuardaPortugalUnknown status
Investigational site number PT-32
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PortimãoPortugalUnknown status
Investigational site number PT-13
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PortoPortugalUnknown status
Investigational site number PT-11
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Santo TirsoPortugalUnknown status
Investigational site number PT-27
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TomarPortugalUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.