Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.

Official Title
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Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone

Conditions
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Schizophrenia, Catatonic, Schizophrenia, Disorganized, Schizophrenia, Paranoid, Schizophrenia, Psychotic Disorders

Intervention / Treatment
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* Drug: Long-acting Risperidone microspheres injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic Subject has been symptomatically stable on a stable dose of an antipsychotic the last month Subject and/or patient's relative, guardian or legal representative has signed the informed consent form Exclusion Criteria: First antipsychotic treatment ever On clozapine during the last 3 month Serious unstable medical condition History or current symptoms of tardive dyskinesia History of neuroleptic malignant syndrome Pregnant or breast-feeding female Female patient of childbearing potential without adequate contraception. Participation in an investigational drug trial in the 30 days prior to selection Known intolerance/non-responder to risperidone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Long-acting Risperidone microspheres injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy/ Clinical Global Impression |  | Week 0, 4, 8,12 | 
| Personal and Social Performance Scale |  | Week 0, 12 | 
| Extrapyramidal Symptom |  | Week 0, 4, 8,12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| +Quality of life SF-36 |  | Week 0,12 | 
| Pain assoicated with injection VAS |  | Week 0, 4, 8, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Schizophrenia, Undifferentiated Schizophrenia, Schizo-affective disorders