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

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone Long-Acting injectable or oral antipsychotics

• Registration Number: NCT01026285
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

International Observational Registry on Schizophrenia

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1085

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
antipsychotic treatment	Risperidone Long-Acting injectable or oral antipsychotics	Risperidone Long-Acting injectable or oral antipsychotics According to label

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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