Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone long-acting injectable. The goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past medication use.

Detailed Description
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This is an Observational, retrospective study on the use of Risperidone long-acting injectable. The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone. Patient outcomes will be evaluated based on pre-existing risk or disease factors and past medication use. Data will be collected from medical charts and other available medical records from one year prior to risperidone treatment until discontinuation of risperidone long acting injectable. The study will compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. Information about past use of anti-psychotic medications will be collected. The occurrence and frequency of adverse events [Extra-Pyramidal Symptoms (EPS) - the abnormal body movements sometimes associated with antipsychotic medications, body weight changes, drowsiness, sexual problems] and the dose or change in dose of Risperidone long-acting injectable will also be collected. The study will also investigate the relapse rate and the hospitalization rate before and after treatment. It is a chart review type of study. No study drug has been used in the study.

Official Title
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Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Other: Retrospective chart review study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria Patients who used to be treated with Risperidone long-acting injectable regularly for at least 3 months Patients whose medical charts or other medical records are available Exclusion Criteria: None
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 |
| --- | --- |
| 001<br> | Other: Retrospective chart review study<br>* Retrospective study chart review long acting risperidone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. |  | From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective disorder, Risperidone long-acting injectable, Long-term evaluation