Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizoaffective Disorder |
Other: Retrospective chart review study |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone |
- Compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. [ Time Frame: From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable. ] [ Designated as safety issue: No ]
- Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 342 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2007 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 001 |
Other: Retrospective chart review study
Retrospective study chart review long acting risperidone
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
This study will enroll patients with diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria and who have ever been treated with risperidone long-acting injectable for more than 3 months.
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Medical Director, Johnson & Johnson Taiwan Ltd |
| ClinicalTrials.gov Identifier: | NCT00644852 History of Changes |
| Other Study ID Numbers: | CR013993 |
| Study First Received: | March 24, 2008 |
| Last Updated: | April 26, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Johnson & Johnson Taiwan Ltd:
|
Schizophrenia Schizoaffective disorder Risperidone long-acting injectable, Long-term evaluation |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 21, 2013