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

Study Overview
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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

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Risperidone Long-Acting injectable or oral antipsychotics


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| antipsychotic treatment<br>Risperidone Long-Acting injectable or oral antipsychotics According to label | Drug: Risperidone Long-Acting injectable or oral antipsychotics<br>* According to label<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risperdal Consta