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New injectable treatment shows promise for schizophrenia relapse

NCT ID NCT05480046

Disease control Sponsor: Rovi Pharmaceuticals Laboratories Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well Risperidone ISM works for people with schizophrenia who were hospitalized after a relapse. Researchers tracked 275 patients over 56 days to see if their symptoms improved and if they could better manage daily life. The treatment is given as an injection and aims to control the disease long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

275 people

The number who actually took part.

Started

Oct 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged 18 years or older at the time of hospitalisation. 2. Patient with diagnosis of schizophrenia, as per clinical judgment. 3. Patient admitted to a psychiatric inpatient unit due to an acute exacerbation. 4. Patient has started treatment with Risperidone ISM within the previous 48 hours, according to the current Summary of Product Characteristics (SmPC). 5. Patient or their legal representative provides written informed consent to participate in the study. Exclusion Criteria: 1. Patient with a diagnosis of schizoaffective disorder, bipolar disorder mental retardation, or other cognitive and neurodevelopmental disorders. 2. Patient with substance-induced psychosis or psychosis during intoxication (patients with comorbid substance abuse/dependence are allowed). 3. Patient unable to answer the study questionnaires. 4. Patient who is currently participating in another clinical study. 5. Patient pregnant or breast-feeding. 6. Patient with a serious and unstable medical condition, forensic patients, or patients with any contraindication mentioned in the SmPC of Risperidone ISM. 7. Patients currently on antipsychotic treatment with clozapine or any long-acting injectable antipsychotic.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Investigational Site number DE-01

    Essen, Germany

  • Investigational site number DE-02

    Chemnitz, Germany

  • Investigational site number DE-03

    Dortmund, Germany

  • Investigational site number DE-04

    Munich, Germany

  • Investigational site number DE-05

    Mannheim, Germany

  • Investigational site number DE-06

    Aachen, Germany

  • Investigational site number DE-07

    Bonn, Germany

  • Investigational site number DE-08

    Greifswald, Germany

  • Investigational site number DE-09

    München, Germany

  • Investigational site number DE-10

    Berlin, Germany

  • Investigational site number DE-12

    Berlin, Germany

  • Investigational site number DE-13

    Werneck, Germany

  • Investigational site number DE-14

    Ansbach, Germany

  • Investigational site number DE-15

    Berlin, Germany

  • Investigational site number DE-16

    Bonn, Germany

  • Investigational site number DE-19

    Leipzig, Germany

  • Investigational site number DE-20

    Hemer, Germany

  • Investigational site number DE-22

    Hamburg, Germany

  • Investigational site number DE-23

    Bayreuth, Germany

  • Investigational site number DE-24

    Neustadt, Germany

  • Investigational site number DE-25

    Eberswalde, Germany

  • Investigational site number ES-02

    Talavera de la Reina, Spain

  • Investigational site number ES-03

    Barcelona, Spain

  • Investigational site number ES-04

    Manacor, Spain

  • Investigational site number ES-11

    Granada, Spain

  • Investigational site number ES-14

    Móstoles, Spain

  • Investigational site number ES-16

    Burgos, Spain

  • Investigational site number ES-18

    Murcia, Spain

  • Investigational site number ES-19

    Madrid, Spain

  • Investigational site number ES-21

    Jaén, Spain

  • Investigational site number ES-23

    Córdoba, Spain

  • Investigational site number ES-24

    Madrid, Spain

  • Investigational site number ES-31

    Vigo, Spain

  • Investigational site number ES-40

    Vitoria-Gasteiz, Spain

  • Investigational site number ES-42

    Torrejón, Spain

  • Investigational site number ES-45

    Barcelona, Spain

  • Investigational site number ES-49

    Lleida, Spain

  • Investigational site number ES-51

    Lugo, Spain

  • Investigational site number ES-52

    Ourense, Spain

  • Investigational site number ES-59

    Huesca, Spain

  • Investigational site number ES-60

    Las Palmas de Gran Canaria, Spain

  • Investigational site number ES-62

    Ponferrada, Spain

  • Investigational site number ES-63

    Majadahonda, Spain

  • Investigational site number ES-65

    Mataró, Spain

  • Investigational site number ES-66

    Madrid, Spain

  • Investigational site number ES-69

    Santander, Spain

  • Investigational site number ES-70

    Jerez de la Frontera, Spain

  • Investigational site number ES-72

    L'Hospitalet de Llobregat, Spain

  • Investigational site number ES-73

    Manresa, Spain

  • Investigational site number ES-76

    Úbeda, Spain

  • Investigational site number ES-81

    Barcelona, Spain

  • Investigational site number GB-08

    London, United Kingdom

  • Investigational site number IT-03

    Legnano, Italy

  • Investigational site number IT-06

    Milan, Italy

  • Investigational site number IT-113

    Palermo, Italy

  • Investigational site number IT-18

    Montichiari, Italy

  • Investigational site number IT-19

    Bolzano, Italy

  • Investigational site number IT-20

    Crema, Italy

  • Investigational site number IT-24

    Brescia, Italy

  • Investigational site number IT-32

    Ancona, Italy

  • Investigational site number IT-41

    Foggia, Italy

  • Investigational site number IT-42

    Milan, Italy

  • Investigational site number IT-44

    Putignano, Italy

  • Investigational site number IT-47

    Manfredonia, Italy

  • Investigational site number IT-65

    Brindisi, Italy

  • Investigational site number IT-90

    Vimercate, Italy

  • Investigational site number IT-97

    Sant'Agata di Militello, Italy

  • Investigational site number PT-01

    Coimbra, Portugal

  • Investigational site number PT-11

    Santo Tirso, Portugal

  • Investigational site number PT-13

    Porto, Portugal

  • Investigational site number PT-20

    Guarda, Portugal

  • Investigational site number PT-24

    Braga, Portugal

  • Investigational site number PT-25

    Beja, Portugal

  • Investigational site number PT-27

    Tomar, Portugal

  • Investigational site number PT-32

    Portimão, Portugal

  • Investigational site number PT-33

    Funchal, Portugal

  • Investigational site number PT-36

    Funchal, Portugal

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