InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics

NCT ID: NCT01026285

Last Updated: 2013-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1085 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-03-31

Brief Summary

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International Observational Registry on Schizophrenia

Detailed Description

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This is an observational, non-interventional registry designed to assess medication usage patterns and to explore, in clinical routine practice, long-term outcomes and relevant factors for patient adherence to treatment, in patients receiving antipsychotic treatment with risperidone long-acting injectable (RLAI) or oral antipsychotics. Six month retrospective data and 1 year prospective data will be collected. According to label

Conditions

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Schizophrenia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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antipsychotic treatment

Risperidone Long-Acting injectable or oral antipsychotics According to label

Risperidone Long-Acting injectable or oral antipsychotics

Intervention Type DRUG

According to label

Interventions

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Risperidone Long-Acting injectable or oral antipsychotics

According to label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag International NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

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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)

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Countries

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Czechia France Germany Greece Russia South Africa Spain Turkey (Türkiye)

Related Links

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Other Identifiers

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RISSCH4230

Identifier Type: OTHER

Identifier Source: secondary_id

CR016630

Identifier Type: -

Identifier Source: org_study_id

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