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Sponsored by: |
Janssen Korea, Ltd., Korea |
Information provided by: | Janssen Korea, Ltd., Korea |
ClinicalTrials.gov Identifier: | NCT00294008 |
The purpose of this study is to collect sufficient retrospective outcome data to allow the evaluation of treatment outcomes with long acting medication compared to previous treatments ,document clinical effectiveness and long-term treatment outcomes of long-acting injectable risperidone and prospectively assess medication usage patterns
Condition | Intervention | Phase |
Schizophrenia |
Drug: long-acting injectable risperidone |
Phase IV |
MedlinePlus related topics: | Schizophrenia |
Drug Information available for: | Risperidone |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study |
Official Title: | Electronic Schizophrenia Treatment Adherence Registry (e-STAR) : An Observational, International Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres. |
Estimated Enrollment: | 40 |
Study Start Date: | December 2004 |
Schizophrenia is a psychiatric disorder affecting 1% of the general population but with treatment costs accounting for approximately 2.5% of total health care expenditures.The majority of health care costs (up to 74%) are accounted for by relapse and subsequent hospitalization or institutionalized care. This protocol proposes a multicentre, retrospective and prospective observational cohort (group of individuals that have similar trait) design, determining aggregate drug usage patterns and commonly used clinical outcomes associated with the use of long-acting injectable risperidone when used as in daily practice. It is believed that such a study can efficiently deliver crucial information for decision makers.
The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 2 years
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR005071 |
First Received: | February 16, 2006 |
Last Updated: | August 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00294008 |
Health Authority: | Korea: Food and Drug Administration |
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