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Sponsored by: |
Johnson & Johnson Taiwan Ltd |
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Information provided by: | Johnson & Johnson Taiwan Ltd |
ClinicalTrials.gov Identifier: | NCT00644852 |
The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients received long-term treatment of Risperidone long-acting injectable with the aim to assess patient outcomes by existing risk or disease factors, patient characteristics, or previous medication.
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | Medical Charts Reviews of Patients With Long-Term Treatment of Risperidone Long-Acting Injectable |
Estimated Enrollment: | 250 |
Study Start Date: | January 2007 |
Study Completion Date: | September 2007 |
This is a non-interventional, retrospective study on the use of Risperidone long-acting injectable . This study is to evaluate the characteristics, clinical responses, and safety issues of patients received long-term treatment of Risperidone with the aim to assess patient outcomes by existing risk or disease factors, patient characteristics, or previous medication.The time duration of data collection will be from 1 year before Risperidone treatment to discontinuation of Risperidone long-acting injectable treatment. Data will be collected from medical charts and other medical records available.The primary efficacy interest of this study is to compare the Hospitalization Days Per Year for psychotic reasons before and after treatment with Risperidone long-acting injectable (this period is defined as starting one month after continuous Risperidone long-acting injectable treatment until last injection) . Full and partial hospitalization days will be collected and calculated separately. The patient's antipsychotic medication (start date, end date, drug, dose and frequency) and the treatment with other (non-antipsychotic) medication will be recorded. Data of records of adverse events (EPS, body weight, drowsiness, sexual problems, etc), frequency, dosage, and change of dosage of Risperidone long-acting injectable (date, reason, dose and frequency) will also be collected.The secondary efficacy interest of this study is the Relapse Rate and the Hospitalization Rate before and after treatment (as defined above).
It is a chart review type of study. No study drug has been used in the study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR013993 |
Study First Received: | March 24, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00644852 History of Changes |
Health Authority: | Taiwan: Department of Health |
Risperidone long-acting injectable, longterm evaluation Schizophrenia Schizoaffective disorder |
Neurotransmitter Agents Tranquilizing Agents Risperidone Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin |
Schizophrenia Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions |
Schizophrenia Serotonin Antagonists Serotonin Agents Mental Disorders Therapeutic Uses Dopamine Agents Psychotic Disorders Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |