InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics
Observational, Non-interventional Registry to Assess Medication Usage Patterns in Clinical Routine Practice, in Subjects Receiving Antipsychotic Treatment With Risperidone Long Acting Injectable (Gluteal or Deltoid) or Oral Antipsychotics
2 other identifiers
observational
1,085
8 countries
98
Brief Summary
International Observational Registry on Schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Typical duration for all trials
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 3, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 24, 2013
June 1, 2013
2.8 years
December 3, 2009
June 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
prospectively assess medication usage patterns under routine clinical practice related to initiation of treatment with risperidone RLAI and oral antipsychotic treatments
baseline, month 1, 3, 6, 9 & 12
Secondary Outcomes (5)
To collect 6-month retrospective and 1-year prospective data to allow the exploration of treatment outcomes including hospitalizations and rehospitalizations, with RLAI and oral antipsychotics, in relation to previous treatments
1, 3, 6, 9, 12 month
To evaluate the reasons for initiation and/or discontinuation of new antipsychotic medications, including patient satisfaction with treatment
1, 3, 6, 9, 12 month
To explore relevant factors for patient adherence to treatment
1, 3, 6, 9, 12 month
To document clinical effectiveness and functionality of patients on RLAI and oral antipsychotics in daily clinical practice (as measured by the Global Assessment of Functioning [GAF] scale
1, 3, 6, 9, 12 month
Long-term safety data of RLAI (25, 37.5 or 50 mg every 2 weeks) and oral antipsychotics will be collected
1, 3, 6, 9, 12 month
Study Arms (1)
antipsychotic treatment
Risperidone Long-Acting injectable or oral antipsychotics According to label
Interventions
According to label
Eligibility Criteria
Patients diagnosed with schizophrenia
You may qualify if:
- Patients must satisfy the following criteria to be eligible for documentation in this non-interventional study: Diagnosis of schizophrenia as well as 6 months of retrospective clinical records
- Newly initiated on or switched to RLAI or an oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago
- Signed informed consent (either signed by the patient or his/her legal representative) is available at the beginning of documentation
- any schizophrenic patient (including those for whom a legal representative must sign consent) can be involved in the study
You may not qualify if:
- Established treatment refractory schizophrenia, defined as treatment failures with adequate trials (adequate as judged by the treating physician) of more than 2 second generation (atypical) antipsychotics and/or clozapine
- History of neuroleptic malignant syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
Unknown Facility
Brno, Czechia
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České Budějovice, Czechia
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Most, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Přerov, Czechia
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Bar-le-Duc, France
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Boulogne-Billancourt, France
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Bourg-en-Bresse, France
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Challans, France
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Créteil, France
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Dax, France
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La Roche-sur-Yon, France
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La Seyne-sur-Mer, France
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Laxou, France
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Marseille, France
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Mont-Saint-Martin, France
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Montpellier, France
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Morlaix, France
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Plouguernével, France
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Rennes, France
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Saint-Avé, France
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Saint-Égrève, France
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Sarreguemines, France
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Verdun, France
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Villejuif, France
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Augsburg, Germany
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Bad Honnef, Germany
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Berlin, Germany
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Bochum, Germany
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Butzbach, Germany
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Chemnitz, Germany
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Coesfeld, Germany
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Cologne, Germany
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Dortmund, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Ebensfeld, Germany
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Frankfurt, Germany
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Fürth, Germany
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Geithain, Germany
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Greifswald, Germany
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Grevenbroich, Germany
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Hamburg, Germany
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Ilmenau, Germany
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Köthen, Germany
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Krefeld, Germany
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Leipzig, Germany
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Limburg, Germany
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Löhne, Germany
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Magdeburg, Germany
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Mannheim, Germany
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München, Germany
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Neuss, Germany
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Oranienburg, Germany
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Plauen, Germany
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Potsdam, Germany
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Riesa, Germany
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Schleswig, Germany
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Stolberg, Germany
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Stralsund, Germany
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Ulm, Germany
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Velbert, Germany
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Wetzlar, Germany
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Wismar, Germany
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Wuppertal, Germany
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Arta, Greece
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Athens, Greece
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Chania, Greece
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Crete, Greece
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Ioannina, Greece
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Larissa, Greece
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Thessalonikis, Greece
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Véroia, Greece
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Kronshtadt, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
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Yekaterinburg, Russia
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Birmingham, AL, South Africa
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Pretoria, South Africa
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A Coruña, Spain
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Burgos, Spain
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Getafe, Spain
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Madrid, Spain
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Monforte de Lemos, Spain
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Salamanca, Spain
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Valladolid, Spain
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Vigo, Spain
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Erzurum, Turkey (Türkiye)
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Eskişehir, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Manisa, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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Trabzon, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2009
First Posted
December 4, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 24, 2013
Record last verified: 2013-06