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

International Observational Registry on Schizophrenia

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Risperidone Long-Acting injectable or oral antipsychotics

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1085

Contacts and Locations

Study Locations

• Czech Republic
  • Brno, Czech Republic
  • Ceske Budejovice, Czech Republic
  • Most, Czech Republic
  • Olomouc N/A, Czech Republic
  • Praha, Czech Republic
  • Prerov, Czech Republic
• France
  • Bar Le Duc, France
  • Boulogne-Billancourt, France
  • Bourg En Bresse, France
  • Challans, France
  • Creteil, France
  • Dax, France
  • La Roche Sur Yon, France
  • La Seyne Sur Mer, France
  • Laxou Cedex, France
  • Marseille, France
  • Marseille Cedex 05, France
  • Mont St Martin, France
  • Montpellier, France
  • Morlaix Cedex, France
  • Plouguernevel, France
  • Rennes, France
  • Saint-Egreve, France
  • Sarreguemines, France
  • St Ave, France
  • Verdun, France
  • Villejuif, France
• Germany
  • Augsburg, Germany
  • Bad Honnef, Germany
  • Berlin, Germany
  • Bochum, Germany
  • Butzbach, Germany
  • Chemnitz, Germany
  • Coesfeld, Germany
  • Dortmund, Germany
  • Dresden, Germany
  • Düsseldorf, Germany
  • Ebensfeld, Germany
  • Frankfurt, Germany
  • Fürth, Germany
  • Geithain, Germany
  • Greifswald, Germany
  • Grevenbroich, Germany
  • Hamburg, Germany
  • Ilmenau, Germany
  • Krefeld, Germany
  • Köln, Germany
  • Köthen, Germany
  • Leipzig, Germany
  • Limburg, Germany
  • Lohne, Germany
  • Magdeburg, Germany
  • Mannheim, Germany
  • München, Germany
  • Neuss, Germany
  • Oranienburg, Germany
  • Plauen, Germany
  • Potsdam, Germany
  • Riesa, Germany
  • Schleswig, Germany
  • Stolberg, Germany
  • Stralsund, Germany
  • Ulm, Germany
  • Velbert, Germany
  • Wetzlar, Germany
  • Wismar, Germany
  • Wuppertal, Germany
• Greece
  • Arta, Greece
  • Athens, Greece
  • Chania, Greece
  • Crete, Greece
  • Ioannina, Greece
  • Larisa, Greece
  • Thessalonikis, Greece
  • Veroia, Greece
• Russian Federation
  • Ekaterinburg, Russian Federation
  • Kronshtadt, Russian Federation
  • Nizhni Novgorod, Russian Federation
  • Saint-Petersburg, Russian Federation
• South Africa
  • Pretoria, South Africa
  • AL
    • Birmingham, AL, South Africa
• Spain
  • Burgos N/A, Spain
  • Coruña, Spain
  • Getafe, Spain
  • Madrid, Spain
  • Monforte De Lemos, Spain
  • Salamanca, Spain
  • Valladolid, Spain
  • Vigo, Spain
• Turkey
  • Adana, Turkey
  • Ankara, Turkey
  • Erzurum, Turkey
  • Eskisehir, Turkey
  • Istanbul, Turkey
  • Izmir, Turkey
  • Kocaeli, Turkey
  • Manisa, Turkey
  • Mersin, Turkey
  • Trabzon, Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with schizophrenia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
antipsychotic treatment; Risperidone Long-Acting injectable or oral antipsychotics According to label	Drug: Risperidone Long-Acting injectable or oral antipsychotics; According to label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen-Cilag International NV

Publications and helpful links

Helpful Links

• InORS - International Observational Registry on Schizophrenia

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 3, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Risperdal Consta
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone; Antipsychotic Agents
• Other Study ID Numbers: CR016630; RISSCH4230 (Other Identifier: Janssen-Cilag International NV, Belgium)