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Sponsored by: |
Janssen Korea, Ltd., Korea |
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Information provided by: | Janssen Korea, Ltd., Korea |
ClinicalTrials.gov Identifier: | NCT00269919 |
The purpose of this study is to evaluate the long-term effectiveness and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) in patients with schizophrenia, and its influence on their quality of life.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: Risperidone long-acting injectable |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | The Efficacy, Safety, and Quality of Life With Long-Term Administration of Long- Acting Risperidone Microspheres (Risperdal® Consta®) in Patients With Schizophrenia |
Estimated Enrollment: | 50 |
Study Start Date: | August 2005 |
Although most schizophrenic patients in Korea are currently taking oral antipsychotic medications, it is estimated that up to 75% of them have difficulty in adhering to their daily oral regimen. A long-acting, injectable formulation may eliminate the inconvenience of daily medication. This is a prospective, open-label, single center study to determine the long-term effectiveness and safety of biweekly injections of risperidone microspheres (intramuscular injections of either 25, 37.5, or 50 mg of risperidone, every 2 weeks for 2 years) in schizophrenia patients in Korea, and its influence on their quality of life. The primary measure of effectiveness is the change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to 96 weeks. The study hypothesis is that risperidone microspheres will be effective in the treatment of schizophrenia as measured by the change from baseline in the total Positive and Negative Syndrome Scale (PANSS) score, and with improvements in the quality of life of the patients as measured by the WHO - Quality of Life score and the Global Assessment of Functioning score.
The patients will receive intramuscular injections of either 25, 37.5, or 50 mg of risperidone, every 2 weeks for 2 years.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR002089 |
Study First Received: | December 22, 2005 |
Last Updated: | April 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00269919 |
Health Authority: | Korea: Food and Drug Administration |
Risperidone long-acting injectable Schizophrenia |
Schizophrenia Dopamine Mental Disorders Risperidone |
Quality of Life Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |